FDA Regulations: Embryo Donation



welcome to today's webinar called donor eligibility what does the FDA have to say presented by dr. Michelle McClure with drumroll please with the Food and Drug Administration dr. Michelle McClure has been a biologist with the FDA's office of tissues and advanced therapies in the division of human tissue since 2004 her primary focus is policy development and regulatory review as it relates to the eligibility of donors of human cells and tissues a perfect guest for us dr. McClure has previous work experience in a cardiovascular and orthopedic tissue processing laboratory at a biotechnology company prior to joining the FDA dr. McCoy received a PhD in genetics and her studies focused primarily on improving our understanding of the biochemical defects that cause cystic fibrosis man that was a challenge to my pronunciation skills this morning dr. McClure we first met dr. McClure as a fellow presenter at the American Board of tissue banking convention in Arizona and we are so pleased to have so many fertility clinic professionals joining us this morning I know all of us will find some point of enlightenment from Michelle's presentation we won't have time for Q&A this morning but Michelle will be sharing with us how you can submit your questions and get timely answers from the FDA if you are experiencing any technical difficulties during the presentation please contact webex technical support get your pens and pencils ready here's the phone number eight six six two nine three eight six six two two nine three two three nine and as a reminder this presentation is being recorded today thank you so much dr. McClure for joining us I turn the presentation over to you okay well thank you can everybody hear me okay I can shake hands all right great well first I want to thank you for the opportunity to speak on this topic and I especially want to thank everybody who has taken time out of their busy schedules to tune into this so my goal for today is to provide an overview of FDA's regulatory approach as it applies to reproductive cells and tissues so I will begin taking today by providing a general overview of FDA's regulatory authority for human drive cells and tissues as well as some important information about registration and listing requirements for cell and tissue establishments the majority of this talk will focus on the donor eligibility requirements including some special exceptions that may be applied to donors our reproductive cells and tissues and then lastly I will provide some information about helpful resources including how to contact FDA should you have questions about the regulatory requirements so before we get started I do want to remind everybody that this presentation is not necessarily a complete listing of all SDA regulations and you should refer to title 21 of the Code of Federal Regulations part 12 71 for complete listing and a link to the electronic version of these regulations is provided at the end of this presentation so let's begin with a general overview of FDA's regulatory authority for cement drive cells and tissues so FDA divided up into several main centers such as those for drugs medical devices tobacco foods and veterinary medicine human reproductive cells and tissues are covered by the Center for biologics Evaluation and Research often called fever for short fever is further divided into offices and the slide that I've shown here shows the different offices and fevers and I've highlighted a few offices that you should be aware of the first was the office of compliance and biologics quality or OCD Q among other tasks this is the office that handles compliance issues that may arise during an inspection of your facility now then individuals that actually come in and inspect the facility are not part of OSI BTU they're actually under an office that is not part of Seaver directly but they communicate their findings to OSI BPO and an OSI BQ handles everything from there so the next office that I've highlighted is the office of communication outreach and development oh cause one key function of this office is to provide kunis communications to our stakeholders this includes providing a single point of contact for establishments or consumers that have questions about fever policies or products regulated by fever and then the last office that I've highlighted is the office of tissues and advanced therapies or air attacks this office handles policies for a variety of biological products including human cells and tissues some of you may have been familiar with the offices previous name which was the office of cellular tissue and gene therapies or OC PGT but as part of a reorganization that occurred in 2016 OCT 12 and o tat was created so okay is further divided up into five divisions and so on this slide I have highlighted a division of human tissues or DHT which is the office that specifically handles policies for human derived cells and tissues including reproductive cells and tissues and this is also the division that I work in so this slide just gives you an idea of some of the types of products that boat at handles such as cell and gene therapies which you see at the bottom of this list or is the product category that we're focusing on today and these are the human cells tissues and cellular and tissue based products or HTTPS so HTTPS are defined as articles containing or consisting of human cells or tissues that are intended for implantation transplantation and fusion or transfer and fewer human recipients the column on the left provide some examples of articles that are considered HTTPS then a column on the right list some examples of articles that are not considered HTTPS most importantly this table shows that reproductive HTTPS such as oocytes semen and embryos are considered HTTPS and therefore FDA's policies for HTTPS applies to oocytes semen and embryos so FDA Jerry framework for HTTPS is divided to regulatory fears the first here is what we typically refer to as 361 HTTP these are HTTP that are regulated solely under the authority of Section 361 of the Public Health Service Act or PHS Act but the authorizes FDA to make and enforce regulations necessary to prevent the introduction transmission or spread of communicable diseases these tissues are subject to the tissue rules listed in 21 CFR part 12 71 and premarket review is not required however to be regulated at a 361 HTTP the HTTP must meet all the criteria set forth and 21 CFR parts 1231 point 10 a reproductive cells and tissues that are intended for reproductive use are considered 361 HTTPS and therefore they must comply with the applicable tissue rule now the other regulatory tier is for HTTP that are regulated as drugs devices and/or biologics I will focus on you so much today because reproductive HP intended for use and reflection and tenets of Ragosa bees are not do not fall under these categories but in general DEET HTTP are those that do not meet all the criteria under 12 21 points in a and therefore are regulated under the authority of section 351 of the PHS F as well as section 351 of the PHS s and/or the Food Drug and Cosmetic Act so these products are subject to the topping on tissue rules as well as premarket review requirement that are listed in other sections of title 21 of the Code of Federal Regulations so as I mentioned the tissue rules are listed in title 21 of the Code of Federal Regulations or CFR part 12 71 the regulations in this part are divided into six sub parts there's subpart a general provision subpart B establishment registration and listing subpart C donor eligibility determinations the Part D current good teaching practices pppp step part ii additional requirements and subpart F inspection and enforcement now stuff Part D and E are in great on a slide because they do not apply to reproductive cells and tissues with the exception of two specific regulations nearby the asterisk and this mainly just refers to the option for requesting exemptions and alternatives to the donor eligibility requirements alright so now I want to move on to a high level of review of establishment registration and listing requirements California 1.10 explains that all establishments that manufacture at and HTTP must register and list their HTTPS which includes providing information about the establishment and the HTTP that they manufacture these requirements apply to both domestic and foreign establishments now it is important that you understand what FDA means by the term manufacturer manufacturer includes any and all steps and recovery ie the collection processing storage wavelength packaging or distribution of any semen cells or tissues and it screenings or testing of the cell or tissue donor and by establishment FPA means a place of business under one management at one general physical location that engages in the manufacture of HTTPS this includes an individual the partnership cooperation association or other legal entity and facilities that engage in contact manufacturing services so as explained an FDA small entity compliance guide ins one general physical location could include different buildings within close proximity provided that the activities and them are closely related to the same business enterprise under the supervision of the same local management and capable of being accepted at the same time so there are some exceptions from the registration and listing requirements few important exceptions that I want to highlight here are establishments that only receive a short ATT to solely for the youth within their own facility in other words no they are not performing any other manufacturing stuffs and establishment that only recover reproductive cells or tissues for immediate transfer and to the sexual enhancement partner so in these scenarios registration and listing are not required it is also very important to note that FDA's acceptance of an establishment registration and HTTP listing does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HTTP is licensed or approved by the FDA so some highlights of the registration and listing requirements includes that in an establishment must submit an amendment to their registration if there is a change in ownership or location and for international establishments if there is a change in the US agents name or contact information establishments are required to update their registration annually even if there are no changes the annual update period is November 15th through December 31st and additional details are listed in 21 CFR parts 1,200 1.21 and 1270 1.25 be also present as an establishment has gone out of business for no longer manufactures any HTTPS then the establishment should and activate their registration and again I want to remind you that these sites do not contain all the details about registration and listing and so I strongly encourage you to review the regulation today I've listed on these slides right so now we'll move on to the main focus of today's presentation which is the donor eligibility determination I will first start with some of the general requirements then I will move on to specific screening and testing requirements as well as some exceptions to the regulation the first what is a donor eligibility determination so a donor eligibility or de determination is based on screening testing of a GTP builders for relevant communicable disease agents or diseases which I may also research you as RC bags a de determination is required for all donors of cells and tissues used in HTTP with some exceptions that I will cover later in this talk and then a CPP must not be implanted transplanted and fused or transferred until the donor has been determined to be eligible again with some exceptions that I will cover later so for all donors SEM has identified the following barfy de HIV 1 & 2 hepatitis B and C viruses human transmissible spongiform encephalopathies including c je and vCJD Trevor NEMA column which is the agent that causes syphilis vaccinia sepsis West Nile virus and Zika virus now the first part agents on this list are described directly and the 1221 regulations last for however were identified as RP dads after the 12 billion regulations have been published so they are described through guidance documents so vaccinia sepsis and West Nile virus were identified and described in the 2007 donor eligibility guidance and Zika virus was described and the recent Zika Zika specific guidance that was published in March of 2016 so going on for viable leukocyte rich tissues such as semen htlv-1 appeal are also considered RC dads and then for all reproductive cells and tissues chlamydia and gonorrhea are also considered or if you dad now I just want to point out that these are everything that we have listed as an RF e dad however somebody to require screening for some of them we require testing for some we require both and I'll go through the details of screening and testing later in this presentation but I just want to point out that just because something is on this list so that must really mean that testing is required for example there are no appropriate test for vaccinia or sepsis therefore we cannot require testing however we have screening recommendations that we put in place instead and again I will go into that more in just a moment all right so when is a donor eligible an order for donors because that are eligible donor screening results must indicate that the donor is free from risk factors for and clinical evidence of infections due to an RC data and that the donor is free from communicable disease risk associated with xenotransplantation in addition donor testing results for RC x must be negative or nonreactive with one exception for a non trip animal syphilis test which I will discuss more about in just a moment so for Reproductive HTTP the type of donor is based on the relationship of the gamete donor to the recipient and there's a regardless of who the intended parent is the for example a gestational carrier is considered the recipient of the HTTP even if that gestational carrier is not the intended parents so in other words an intended parent may also be considered a donor so for regulatory purposes a donor for Reproductive HTTP may be an anonymous donor a directed donor or a sexually intimate partner so FDA defines a directed donor as a direct as a donor of regionals of cells or tissues to a specific recipient who knows and is known by the recipient before donation so this includes semen FOA site and embryos to which the donor contributed the spermatozoa or Ella site okay so now I'll move on to some specific specific information about donor screening so the 12:31 regulations explain that you must determine a donor to be ineligible if you are ignorant by any communicable disease risk associated with Dino transplantation or if you identify a risk factor for or clinical evidence of any of the RC death for which screening is required currently donor screening are following our seed on for all donors this includes HIV HPV HCV UNT SES including CJD Treponema pallidum West Nile virus Zika virus sepsis and vaccinium for donors of viable leukocyte rich tissues such as semen this also includes hp/lb and meant for donors of all reproductive cells and tissues you must also screen for chlamydia and gonorrhea so part of the donor screening process includes review of relevant medical records relevant medical records include a current donor screen or current donor medical history examinations a current report of the physical examination and other records is available so other records may include that are not limited to you additional raft test results others in those are required by FDA medical records or any relevant information from other sources I know you see on the side there are also things like corner and autopsy reports but just keep in mind that some of these regulations that I'm going through apply few donors of other types of tissues that are is recovered usually after death alright so you must review these relevant medical records and ask questions about the donors medical history and relevant social behavior including risk factors for RC dads and communicable disease risks associated with xenotransplantation a list of conditions and behaviors that increase the donors relevant communicable disease risks can be found in section 4 e of the donor eligibility guidance due to time limitations I will not go through this entire list but I strongly encourage you to use a list closely you must also review with the relevant medical records for clinical evidence of RC Duns and again I won't go through this list but a list of examples of clinical evidence that you should consider is provided in section 4f of the donor eligibility guidance and all documents that are mentioning throughout this presentation for all of my provided a link to them at the end of the talk state and then in addition you should review the records of the physical examination for any signs that might indicate a high risk behavior for an inspection with an RC bag for this you may rely on records or recent report of a physical examination by other health professionals and for living donors may examine only those parts of bodies that are necessary necessary to evaluate for our feed ads based on results of the medical history interviews and review of available records so a list of examples of physical evidence of our CDs or high risk behaviors can be found in sections for G of the donor eligibility guidance so if you have performed a complete donor screening procedures on a living donor within the previous six months then you may use an abbreviated donor screening procedure for repeat donations however you still must determine and document any changes in the donors medical history that have occurred since the previous donation that would make the donor ineligible including relevant social behavior support example you do not need to conduct a new physical examination or a new review of relevant medical records but you should remind the donor about behaviors that could put him or her at risk of relevant communicable diseases and you should ask the donor if there have been any changes in the donors history or risk factors since the previous donation and again this thirst applies only as a complete donor screening procedures hastens has been performed within the previous six months now since week o virus is a relatively new RC dad I wanted to take a moment to provide some additional information about the virus and FDA screening policy a guidance document for screening HTTP donors for Zika virus was published on March 1st 2016 to date this is the only Zika related guidance that FDA has published for HTTP any other that you might see are written for blood and blood components and do not apply to HTTP so with regards through the HTTP guidance that was published on March 1st 2016 this guidance identified Zika virus as an RFC dad and provided information about donor screening for living donors of HTTPS which includes Siemens Louis Ison embryos you should consider the donor and eligible if they have any of the following risk factors one a medical diagnosis of Zika virus within the past six months two resident and/or travel to an area with active Zika virus transmission within the past six months and I'll talk more about active areas in just a moment or three specs within the past six months with a male who is known to have either the third risk factors listed in items one or two so this slide was some of the reasons why we had established the current screening approach for living donors we know that approximately 80% of infected individuals are asymptomatic and the virus can cause serious birth defects numerous cases of sexual transmission have been reported and sexual transmission has even occurred from asymptomatic males visa RNA has been identified and semen I've waited six months after the point of infection although in these cases is unclear at what point the virus may have become non infection however infectious virus has been detected and semen as late as 69 days after symptom onset and the upper limit of the viral persistence remains unclear Zita RNA has been detected and tissues such as semen even after it is no longer detectable on blood which makes the traditional approach to drug testing a challenge and lastly you can have been detected and a cellular component of semen which suggests that sperm washing techniques may not be effective against Zika virus however there are numerous studies currently underway to help us better understand this virus so as I mentioned on an earlier slide as part of FDA screening approach for Zika virus risk factors is based on residents and/or travel to you an area with active ie mosquito-borne Zika virus transmission and this is as identified by the CDC so in the guidance document that was published in March 2016 FDA divided a link to a CDC website on Zika this website contains a special link for the blood and tissue collection community and the specific URL for that link is what's not here on the slide the page that this link goes to is what establishments should use to identify active areas for the purpose of donor screening we recommend that you check this page often for updates and changes to the active areas when you go to its website you will notice that the page identifies areas as active or previously active there is no map on this page and there are no red or yellow areas so if you're looking at a map or information about red or yellow areas then you're looking at the wrong page for the purpose of donor screening and this is important to be aware of because these defined areas of active transmission may be different from areas for which PPS issued travel guidance and this is because the risks and concerns for different populations may be evaluated differently for example the information that CDC provides for pregnant women which is listed on their pregnancy website is different from the information for determining eligibility of a donor so this is a screenshot of the top of the website that you should be using when screening a donor for travel a red mattress and there's a qrl is listed at the top of the slide the red arrow points at the beginning of the list of areas of active transmission this list contains areas within and outside of the United States and also the dates through which the area is considered active now I want to point out this little gray box at the top which the blue area of arrow is pointing to this box talks about a potential increased risk to donors based on the potential that donors in certain non active areas in Florida could travel in and out of areas with active transmission as part of their normal daily activities and not be aware that they traveled into an area with active transmission therefore out of an abundance of caution CDC provided information about these additional counties the area subscribed in this gray box are not areas with active transmission unless they are also listed under the active areas section below so residents in or travel to an area that is not active would not make a doughnut ineligible and establishments can decide if there's any additional considerations that they want to make regarding these non active but potentially increased risk areas so people often ask about testing Dornish for Zika virus currently FDA does not provide any recommendations on donor testing for Zika we work closely with US government partners and manufacturers interested and developing testers for HTTP donors and will consider testing recommendations once appropriate tests are available in the meantime if testing is performed in addition to donor screening the results of that test must be included in the donors relevant medical records a donor is considered ineligible if a test is reactive or positive even if it was an investigational test that was used however a negative or nonreactive test does not override any risk factors identified in the March 2016 featured items so in other words if a doughnut if a donor with an or has traveled through an active area within the past six months there is no scenario in which the donor can be considered eligible regardless of any testing that is done and as I mentioned earlier certain cells and tissues such as semen haven't bounced because of and infectious evil and a virus is no longer detectable and that individualists was therefore a negative blood test does not guarantee that other cells and tissues are free of the virus and so keep in mind that there are certain scenarios in which you are allowed to use these HTTP from an ineligible donor and scenarios in which screening testing are not required go through more those in detail later in this talk right so now we move on to some information about donor testing so in general testing must be performed using an appropriate FDA license cleared or approved donor screening test with the exception of chlamydia and gonorrhea which are clarified in 1281 point ABC for chlamydia and gonorrhea there are no screening tests available and therefore we make an exception for these of certain types of diagnostic tests instead but in all cases the test must be performed according to the manufacturer's instructions for use and they must be performed in a laboratory that has been certified by CLIA for performing those functions or equivalents as determined by CMS assessment that's used for donor testing must be collected at the time of recovery or collection of the HTTP or within seven days before or after II before or after recovery for donors of oocytes and certain hematocrit progenitor cells the specimen may be collected up to 30 days prior to or within 7 days after the HTTP is recovered hour please note that this 30-day extension does not apply to semen donors there are some additional criteria for anonymous semen donors for all anonymous semen donors you must collect a new specimen at least six months after donation of the semen and test assessment again for all required communicable disease agents in other words each donation must be quarantined for at least six months and you must have at least one complete set of test results both before and after the six-month quarantine period so for repeat dollars discontinue donations you should wait at least six months from the final donation and retest the donor to qualify the final donation with the exception that you can use the results for chlamydia gonorrhea and West nine that were obtained at the final donation or anytime afterwards as a follow-up test and an addition to repeat team and donors for whom retesting edge required such as anonymous donors that I just described you do not have to collect a new specimen for testing at the time of each donation all right so when is a donor considered else ineligible based on testing so to me a donors assessment test positive or reactive on a stain test for an RT guy would be considered ineligible with one exception for syphilis test so for syphilis a donor with a reactive non Treponema screening test for syphilis may be eligible if a subsequent company no specific test is performed and found to be negative however if the donor has a positive traveling all specific test they are considered ineligible donors must also be assessed for classman dilution sufficient to effect test results although this is likely a rare finding for Reproductive HTTP donors so this slide to survive is provided as a reference to help you understand when a donor is eligible or ineligible based off of syphilis test results as you can see if you start with an entrepeneur screening test if that test is nonreactive then no further testing is required however if you start with an entrepeneur screening test and the result is reactive then that donor is considered ineligible and less you retest using a specific animal test and that result is found to be nonreactive if that result is reactive to direct and knowledgeable on the other hand if you do your initial screening using a trap animal specific screening test then the algorithm is much simpler if that test is reactive the donor is knowledgeable regardless the follow testing and or if that test is nonreactive the donor is eligible and the reason for this difference is that a donor who has been previously successfully treated for syphilis they may stay positive on a technical specific test for much of their life and they aren't next that they don't especially have an active syphilis infection and still because of that reason we allow with other options for an entrepreneurial screening test however the non-technical screening test may show up as progress for other types of conditions and therefore we have that often to do a trappin anal confirmatory test so each establishment may choose which of these algorithm they want to follow all right so the key thing to remember here is that if a donor has a positive Trek normal specifics at the endpoint they will be considered ineligible however keep in mind that Martha Doran had been successfully treated for syphilis and at least 12 months have prospect successful treatments then our new joint eligibility can be made which includes repeating this all discrete required screening and testing and the donor may be eligible provider that syphilis testing is now negative an information about how you handle past syphilis tests can be found in section 4 e of the 2007 donor eligibility guidance so what agents do you have to test for as I mentioned just because something's an RFC dad doesn't mean that there's a test available so this slide lists the agents that we currently require testing board so all donors of HTTPS must be tested for HIV 1 & 2 HBV HCV and Treponema pallidum all living donors must also be tested for West Nile virus donors of viable leukocyte rich HTTP such as semen must also be tested for htlv cuts 1 & 2 and CMV now you may have noticed that CMV was not our DRC guide list since sandy is not an Archie dad a positive test would not necessarily make the donor ineligible instead FDA requires that you establish and maintain procedures governing the reason HTTP Thermidor net tested positive for CMV now if you have questions about the clinical significance of using an HTTP from a CMV positive donor you may want to contact appropriate healthcare professionals or the CDC although use of a CMV HTTP from the cmd+ donor is not prohibited by FDA there may be other clinical reasons why you may or may not want to use a HTTP and in for donors of any reproductive HTTP you must also test for chlamydia and gonorrhea and for some of these agents more than one type of test might be necessary to adequately and appropriately test for the are feed on so I'm not going to go through this entire table but this provides a summary of the specific types of tests that FDA has identified as necessary to adequately and appropriately test for each RC guide for example for HIV one FDA recommends using an FDA licensed screening test for against HIV one in the body as well as an HIV one math test or nucleic acid test and that's just one example where more than one test is considered necessary to adequately and appropriately test for evidence of an RC down so all of this information can also be found in the guidance document which I've listed and the white box at the bottom of this slide and again links to all these documents are provided at the end of this presentation so I just wanted to take a moment to provide some additional information about West Nile virus testing the guidance was published in September 2016 which explains in mica tests living donors for West Nile virus using a licensed nucleic acid test or NAT tough and the United States this testing may be limited to June 1st through October 31st of each year however for establishments that are located outside of the US they should implement West Nile virus testing year-round and the reason for this is that data is available epidemiological data is available to us to review for the United States and so we can identify when the peak mosquito fevers are and continue to monitor that however that type of information is not necessarily available to us for other countries and there for West Nile virus testing year-round should be implemented now any donor with a reactive or positive West Nile RFS is considered ineligible and the testing requirement is an addition is in addition to the screening criteria described in the 2007 zona eligibility guidance which explains that if the donor had a medical diagnosis or suspicion of West Nile West Nile virus infection within the past 120 days or they had a positive a reactive cluster West Nile virus within the past 120 days then the donor is ineligible that means that if a donor test prod live you may wait 120 days then perform a whole new donor eligibility determination including testing for West Nile virus at the donor test non-reactive at this point then he or she may be eligible to donate provided that all other screening and testing requirements are met now for repeat Steam donors from him assessment has already been collected and tested and for him the six-month quarantine and retesting is required you are not required to collect the donor specimen for testing at the time of each donation however you should collect a specimen for West Nile virus mat testing for the first donation that occurs within that June 1st through October 31st testing period even if an earlier specimen was collected and tested so now I'm going to take just a few minutes to go through some important exceptions to the donor eligibility requirements that you should be aware of first there are scenarios in which you may use an HTTP from a donor who has been determined to be ineligible this includes reproductive HTTP from a directed Reproductive donor which is defined and 1230 1.3 L if you use an HTTP under this exceptions there are special labeling the physician notification requirement that you must follow I mean this document that you notify the physician of the results of are see death screening and testing so although FDA permits the use of HTTPS under this exception and a stem or treating physicians may decide not to depress each risk there is still a clinical decision there as to that has to be made regarding whether or not you're going to still use each HTTP even though SCA does not prohibit their use now this exception applies only to donors for whom the donor eligibility determination had been completed and the donor was found to be ineligible for example if you identify that a donor has a risk factor that reads that will result in an ineligible determination you cannot just stop there and call the donor and eligible you must complete the donor eligibility determination that you identify all potential risk factors so you can communicate those to the physician appropriately there are some exceptions for use of HTTP prior to completion of the donor eligibility determinations but those exceptions do not apply to reductive HTTP there are also several scenarios in which a donor eligibility determination is not required so this includes cells and tissues for taller disputes reproductive cells and tissues donated by a sexually intimate partner of the recipient for Reproductive Youth crier preserved reproductive cells or tissues other than embryos that at the time of donation were exempt from the te requirement but were subscript subsequently intended for a directed donation note that this is only for a directed donation and not fair anonymous this exception may be used when additional donations are unavailable such as due to infertility or the health condition of the donor and appropriate measures are taken to screen and test the donor before transfers to recipients our last exception here applies to embryos that were exempt from the donor eligibility requirements at the time of cryopreservation ie they were originally intended for use and a sexually intimate partner but are now stuff to consented for a directed or anonymous donation so in this scenario appropriate measures should be taken to screen and test of donor or donors before transfer to the recipient when and for all these exceptions there are special labeling requirements that apply again just like with ineligible donors and some of these scenarios you might have identify or unknown risk factors and although FDA permits the use of these embryos under this exception there is still a clinical decisions that the establishment and treating physician may want to make as far as whether or not they actually want to implement these embryos into your recipients the recently an additional exception for embryos was added to the regulation this new rule says that an embryo originally intended for reproductive use for a specific individual or couple that is subsequently intended for directed or anonymous donation for Reproductive use is accepted from the prohibition on use under 12 21 point 45 C you know applicable donor eligibility requirements under subpart C of this part are not met and I'll try to simplify in a moment what that regulatory mood will actually mean so however the rule does point out that this did not create an exception for deficiencies that occurred in making the donor eligibility determination or in performing the donor screening or testing proceeding and of course if you use an embryo under this exception then special labeling requirements must be applied so what does this really mean in general this exception was created to better accommodate individuals or couples learning access to embryos intended for reproductive youth while continuing to emphasize applicability of the donor screening and testing requirement for the individual gamete donors so although the donor eligibility requirements still apply this rule gives establishments the option to use embryos already formed even as a deficiency occurred when making the donor eligibility determination so for example if an establishment discovers that an error was made which being an along the seam and donor whose gametes for you to create embryos for example David donor answered yes to a risk question however when making the donor eligibility determination that was that answer was missed and the donor would inappropriately identified as being eligible when they should have been ineligible so in this case the establishment can still and there's a scenario in which that error was not notice was not identified until after the embryos had been formed so in this scenario that establishment can still proceed with using the embryos under this exception however upon inspection by FDA that establishment may still be held accountable for any deficiencies identified and their donor eligibility determination process but the use of the embryo is permitted so in other words if that mistake if a CIA if FDA identified that the mistakes occurred because there is a problem in your quality program then they may just identify that as a problem during an inspection however just because I did identify that it doesn't mean you can't use the embryos so but hopefully that explains a little bit what this rule actually means forever is important to keep in mind that basically this rule is creating an exception so that embryos that have been formed can be used there is a process in mind for you to be able to use pretty much any embryos that have been created now add with all these past several slides that I have shown which explain scenarios in which embryos may be used even when risks have been identified or risks are unknown while FDA does not prohibit the use of these embryos there may still be risk factors and so an establishment or treating physician may want to discuss these risks with the intended recipient and based on those risks may decide that is they do not want to implant these embryos or make them available for subsequent donations so even though the use is not prohibited by FDA the establishment or individuals may choose not to use or make Andrea's available for using themselves or with other donation okay so clear now I just wanted for about Krishna and his presentation so I just wanted to provide some additional information about helpful resources especially since the information recovered is really only an overview of some of FDA's policies so here as a writer that links to FDA's tissues home page this page will connect to multiple other pages related to tissues that contain helpful information such as a page that lists all of the the currently available tests that can be used for donor screening or for donor testing I've also provided a link to the electronic version of 21 CFR part 12 71 so this is a very important resource to make sure that you have and there are two different versions of the electronic Code of Federal Regulations this specific URL will take you to the most up-to-date version I've also provided a link that provides additional information about tissue establishment registration and a link to a page that with all the HTTP related guidance documents now this next slide lists the specific URLs for the guidance documents that I discussed today but I just want to remind you that all of these can also be accessed using the general guidance document link that I provided on the previous slide so I also want to encourage you to sign up for automatic updates from FDA using the URL provided here you can subscribe to the biologics mailing list and receive notification about new guidance new regulations upcoming workshops and advisory committee meetings and all kinds of other helpful information related to HTTPS so even as an employer FDA I am subscribed to these updates and I strongly strongly encourage you to do the same and lastly and short to emphasize that you should please feel free to contact FDA if you have any questions consumers can contact FDA at OSI OD or okata at seaf hhs.gov manufacturers which includes establishments handling reproductive HTTPS in contact fda at industry that biologics at fda HHS gov these emails go to our office of communication outreach and development or oh god they are there to serve as a primary point of contact and to answer your questions as quickly as possible if they are unable to answer your question then they will forward your inquiry to be a perfect product office or division now some of those once and great get sorted those offices or divisions a response might take longer therefore it is that the go to oh cause first to see if it is something that they can answer right away if not available for your inquiry long to the appropriate personnel so in addition if you want to speak directly to a consumer Safety Officer or public affairs specialist you may call two four zero four zero two eight zero one zero or one eight hundred eight three five four seven zero nine and again these numbers go directly to our office of communication outreach and development I just want to thank you all for taking time out of your day to witness this presentation and I hope that you have found this information helpful thank you yeah thank you so much all that was wonderful just as a reminder for everybody who's still here this webinar was recorded and we will be sending out the link to the recording for any registrants along with a copy of the slide so all of those helpful resources and links that she provided you will have access to and if you have any further questions you will also have that contact information so you can reach out for whatever that might be so thank you so much for everybody that attended we really

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