A Device Primer: 510(k)s, PMAs, IDEs

A Device Primer: June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for RA managers, business development managers and staff; principal investigators, IRB members, CRAs, academic sites; lawyers, R&D, and those working on combination products, cross-functional medical products and those wishing an introduction to devices. Get up to speed on medical device clearances and approvals! This tutorial demystifies FDA's medical device requirements.

Instructor:

Barry S. Sall, RAC
Principal Consultant
PAREXEL Consulting, United States

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GAO Says Device Reviews Are Taking Longer…and FDA Says It Is Because Your Submission had Quality Issues

In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and premarket approval (“PMA”) applications.

The study found that while FDA met performance goals for 510(k)s and the average number of submissions per year remained generally steady during fiscal year (“FY”) 2003 through FY 2010, the review times for 510(k)s increased.  Likewise, review times for PMAs also increased despite FDA meeting most performance goals for PMA applications.  There has also been a decrease in the number of 510(k) clearance determinations and PMA approvals.  In sum, FDA is taking longer to complete the reviews of 510(k)s and PMAs when the purpose of the user fee program was to streamline the regulatory process.

And who is responsible for this unintended effect?  While assuming some responsibility, FDA points a heavy finger at industry stakeholders.  We will explain this further below, after first providing a brief overview of the device user fee program and discussing the noteworthy GAO study results.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/04/gao-says-device-reviews-are-taking-longerand-fda-says-it-is-because-your-submission-had-quality-issu.html

FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions

Article preview from "The Gray Sheet"-  April 2, 2012
Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions Article preview from "The Gray Sheet"-  April 2, 2012
FDA’s final guidance describing how the risks and benefits of devices are considered during pre-market reviews excludes 510(k)s from its scope after industry objected to inclusion of 510(k)s in draft guidance issued last summer.
Released March 27, the final guidance also includes information on risk-benefit determinations for de novo classification petitions that was not included in the August 2011 draft version.

http://www.medicaldevicestoday.com/2012/04/fdas-final-risk-benefit-guidance-excludes-510ks-adds-de-novo-petitions.html