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

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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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

FDAnews Management Report Available

http://www.onlinetmd.com/fda-management-report-040312.aspx

Despite years of harmonization talks, the EU and United States still follow very different marketing approval processes for medical devices. In addition, when the EU's MDD went into effect in 2010, those differences are more pronounced.
Failing to know the differences could critically handicap your time to market and ability to operate efficiently.
Failing to comply with those differences could shut you out of EU markets completely.
EU and FDA regulators continue to apply different sets of requirements for medical device market approval, despite longstanding attempts at harmonization.
Do you understand how CE marking, PMA approval, and 510(k) clearance processes differ? Are you prepared for the impact of recent major revisions to the EU Medical Devices Directives?
Here is how to make sure you're fully informed – and in compliance.