Bullet Proof 510(k) – Latest FDA Proposed Changes to the Process – GlobalCompliancePanel

welcome ladies and gentlemen to global compliance panels live webinar on a bulletproof 510 K latest FDA proposed changes to preach to the process my name is Ricardo and I am going to be your host today on behalf of the global compliance ballentine I would like to thank you for being part of this event today's webinar will be presented by mr. David R Dill's mr. Bill's currently an independent quality regulatory and compliance consultant with an accomplished and proven track record has more than 19 years of direct and hands-on experience in the FDA regulated industry with emphasis and focus on class 1 2 & 3 medical devices in whiterow Diagnostics pharmaceuticals and biologics operations in the areas of regulatory affairs compliance and QA systems mr. dill has provided regulatory and compliance consultative services on behalf of global clients and subcontracted by third party service providers as well as providing independent services involving all stage of the product approval submission and commercialization process clinical affairs auditing etc he has been previously affiliated with well-known medical device manufacturers with increasing responsibilities in the regulatory and quality arena his background in cabooses brought capabilities in quality systems validation regulatory affairs compliance and interfere interfaces with FDA and international regulatory agencies he tries to optimize business performance through proactive strategies to mitigate compliance exposure and represents companies to regulatory agencies and facilitates company decision-making by Framing issues presenting options remediation and objective business or by advice for manufacturers we are honored to have such a distinguished person such as David our deals with us today to present this webinar before we like to before we begin I would just like to inform your the program outline for today's training session this webinar is for three hours duration first able to take you to today's webinar highlighting the areas that would be covered and he would then share with you his presentation also just like to keep our attendees informed that we will have a short break maybe NR or almost 90 minutes into the session wherein we could take a short break and then get back to the session once again and if you do have any questions as well do send me a chat message so that we can gather up all the questions and attend to all the gathered questions at the end that just towards the Q&A session so if if any of our attendees do have or do get disconnected from the conference all the teleconference as well we request you to please follow the same procedure to join back again now that we are all ready to start I request David to take it from here thank you Ricardo I also would like to extend my warm welcome to our participants online today for webinar for approximately three hours on how to construct and maintain a bulletproof 510 K and more importantly as a special supplement to our presentation today the most current and hot off the press latest FDA proposed changes to the fighting 510 K program for 2011 and going forward there has been some recent developments over the past 45 days which the group may find to be quite interesting since it will have an impact on the premarket notification process stay tuned and we're going to go into substitute details as to what these changes reference as well as the impact to defied Kincaid process again welcome as stated previously this is a three hour primer and overview to the premarket notification process that be in the 510 K delays update to FDA's proposed changes to the program something changes absolutely will go live and be fully deployed and implemented for 2011 and I will identify and confirm those changes here today part of our other agenda related items include the differences between the traditional special and abbreviated submissions understanding substantial equivalence and how that's going to be applied and also why that's going to be very important on behalf of you the manufacturer whether your class 12 device manufacturer and or in vitro diagnostics we also will address who is required to submit the application to the agency where to submit the 510 K and some of the other administrative responsibilities that you must conform to and adhere to in order to ensure success and then certainly when is and is not required if your device company there are certain assumptions and exclusions which will briefly identify here today also where to submit the 510 K it's going to be very important terms of the administrative responsibilities and I will certainly go into morals in detailed as to why that will be extremely business critical on your behalf before you submit your application yes there are some assumptions to the process and also additional special considerations that will identify and certainly a very critical item that we will expound on is how to locate a predicate device and go through the content and the appropriate and required format of your 510 K process another term which will introduce you to and gives examples on is the de novo process and certainly the expectations for possibly marketing a low risk device cool we certainly want to understand the potential and real impact of FDA's proposed changes to the 510 K process and white manufacturers absolutely will need to pay attention and then finally we'll have adequate time for our Q&A and also faq is which I will redirect back to our audience as we proceed to our wrap-up and debrief however as alluded to from earlier we will take a short break probably within 90 minutes upon initial of our presentation duration for this break will be anywhere from approximately five to seven minutes and then we'll immediately resume our presentation contact information great self-explanatory for those who should have any questions inquiries or request for clarification on any of the materials and content to be presented hereand today and certainly contact global compliance panel with any additional inquiries and we will certainly follow up as padishah slee to all of your requested information as well as other inquiries as deem appropriate and necessary now as we get started here today a couple of things I would like to share with the group this course is certainly designed and constructed for someone at the beginning as well as to the intermediate level 2 510 K program however even for the veterans that we have online today on the 510 K process this is certainly going to be a good refresh in a nice overview some of the key expectations highlights and your prescribed set of responsibilities in order to ensure that you're able to prepare for construct process manage handle and submit your application to the agency for review in dis positioning so it really will encompass all of our groups based on various areas of expertise or lack thereof and that certainly hope this will provide a nice overview of the entire 510 K process from pre to post but nonetheless we have major changes proposed for the 510 K program more than 60 proposals and changes from 2010 today you will be aware of the most recent changes have been approved that will be fully implemented in 2011 also following the public comment period CDRH that it will announce which recommendations it will implement for judge it tomm lines for implementation We certainly have timelines that we will disseminate to the group here today and I will give you a brief historical snapshot and narrative behind see derechos 510 K working and also additional information regarding our medical device trade groups and cleaning Avva med so stay tuned to the latest news and updates in our presentation first and foremost sup little background information the submission first and foremost is not required if your device categorically has been exempt by the classification regulations and the respective 21c of our parts as noted in addition most of our class 1 devices certainly are going to be exempt / FDA or your device obviously will require a PMA which would be a life-supporting life-sustaining device which means a higher classification that being a class 3 or your summation is not going to be required if your device was already legally distributed and in the supply chain by the same firm in the US prior to that very famous date of May 28 1970 such and it has not been significantly changed since then or the rights to market pre amendment or a 510 K co device had been acquired from another firm more importantly the device in question has not been

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