Final 510(k) Refuse-to-Accept, Premarket Reviews and eCopy Guidances Two Experts Decode the FDA’s Latest Requirements

Held Feb. 21, 2013

The FDA has recently issued three guidances to help you with your 510(k) and PMA submissions.  While the guidances are full of checklists and other helpful tools, there are still questions about how to use them.  Does a “yes” or “no” in a particular box mean a refuse-to-accept (RTA) letter?  Do some answers fall into a gray area — where the answer is “maybe.”

If your 510(k) or PMA filings are typically complicated or you’re not experienced at preparing them, be prepared for more RTAs, lots of rework and lengthy delays getting to market.

To help you understand these important new guidances, FDAnews has secured one of the industry’s leading 510(k) experts and a former FDA senior device reviewer to walk you through each detailed page and checklist of the guidances.

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On Dec. 31, 2012 the FDA released three final guidance documents:

  1. “Refuse to Accept Policy for 510(k)s”: Comprising 79 pages the guidance’s message is relatively simple — use the included 3 checklists and you are on your way to fulfilling the filing acceptance criteria.  Fail to include a complete, well thought out filing and you’re going to get a RTA letter and you have to try again.  Plus, the FDA’s review clock doesn’t start until your 510(k) submission is accepted.
  2. “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)”: Only 31 pages, the PMA guidance is similar to the RTA guidance.  It includes a checklist that reviewers follow to determine if a submission is “administratively complete.”  If the filing is sufficiently complete, a substantive review occurs.  If not, it’s back to the drawing board for you and your team.
  3. “eCopy Program for Medical Device Submission”:  This guidance now requires that all submission data must be sent through the FDA’s eCopy program to be reviewable.  No more attaching CDs with large data sets to paper submissions.

These guidelines form the foundation for successful 510(k) and PMA submission.  If you don’t understand the nuances of these guidances, you are doomed to delays, rework and most importantly, lost profits!

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Order the CD and transcript of the CDRH Issues Final 510(k) Refuse-to-Accept, Premarket Reviews and eCopy Guidances webinar and you will get:

  • An understanding of the background behind the issuance and the FDA’s motivation for these guidances
  • Point-by-point review of the “Acceptance Checklists” focusing on many of the points that have been deemed difficult or subjective in nature
  • Insights into how the guidances differ from previous FDA policies — what’s changed and what’s stayed the same
  • How the guidances might impact your products in previously unforeseen ways

Meet Your Instructors

Laurie Clarke is a partner in Partner in King & Spalding’s FDA & Life Sciences Practice Group. She specializes in premarket submissions, including 510(k) premarket notifications, investigational device exemption (IDE) applications, pre-IDE submissions, premarket approval (PMA) applications, amendments, and supplements, reclassification petitions, de novo review submissions, device designation requests for combination products, and requests for humanitarian use designation. She has represented clients ranging from small start-up companies to multi-national corporations on a broad spectrum of medical device issues. Ms. Clarke obtained FDA clearance or approval for virtually all of the devices for which she served as regulatory counsel, including many devices that FDA had previously rejected or for which the Agency had issued major deficiency letters before she represented their manufacturers. She received a unanimous recommendation for approval from FDA’s panel of outside medical, ethics, and statistical experts for a client’s product to regrow bone even though the clinical data was equivocal. Ms. Clarke negotiated favorable indications for many clients’ devices, including devices for which their competitors’ devices had much more limited indications. Ms. Clarke graduated, cum laude, from Smith College and received her Master of Public Policy degree, with a concentration in health policy, from Harvard University’s John F. Kennedy School of Government. Ms. Clarke graduated from Stanford Law School, where she served as an associate editor of the Stanford Law Review.

Lynette Zentgraft is a Senior Regulatory Consultant in King & Spalding’s FDA & Life Sciences Practice Group. Prior to joining King & Spalding, Ms. Zentgraft was a Senior Scientific Reviewer for medical devices at CDRH’s Office of Device Evaluation. There, her responsibilities included the review of premarket notification (510(k)), investigational device exemption (IDE), premarket approval (PMA) applications, and other regulatory submissions. Ms. Zentgraft is a graduate of Rensselaer Polytechnic Institute where she received her Bachelor of Science degree in Biomedical Engineering in 1992. She also received her masters degree in Applied Physics and Engineering in Biomedicine from Johns Hopkins University in 1998.

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This Audio CD/Transcript package is a must for professionals in the device industry, including

  • Representatives of manufacturers and marketers of 510(k) medical devices
  • Regulatory affairs professionals
  • Strategic planning and business development staff
  • In house counsel
  • Outside FDA counsel

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