Spring AMDM in Review

The Association of Medical Diagnostics Manufacturers (AMDM) held its annual meeting April 22-23, with an OIR Submissions workshop and Pre-Submissions workshop April 20-22.  The two workshops were “FDA 101” for regulatory professionals, with the majority of speakers being from the FDA and covering all aspects of OIR submissions.  But, even for seasoned regulatory professionals, there was plenty to learn.

For example, there was a session on FDA’s Medical Device Development Tool (MDDT) pilot program, to which FDA has accepted five proposals.  MDDT is a voluntary process to qualify tools that are used in the development and evaluation of medical devices outside of the regulatory submission; they are intended to save time on the development and review side. There also was a session on Unique Device Identifiers, or UDIs, which are global unique numbers that will identify almost every individual device. UDI compliance is already in effect for Class III devices and the majority of Class II devices will need to comply by September 24, 2016.

Of course, it wouldn’t be an FDA-industry meeting without a discussion of Laboratory Developed Tests (LDTs).  Elizabeth Hillebrenner, policy advisor at FDA, gave an overview of the proposed LDT regulation during the OIR Submissions workshop and Liz Mansfield, deputy officer director for personalized medicine at FDA, gave an update on LDTs and personalized medicine during the final day of the annual meeting. In response to the draft guidance documents, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the FDA received more than 1,400 comments from approximately 300 individual commenters. FDA also announced that it has formed a joint task force with CMS on LDT quality requirements so as to not duplicate compliance efforts.

Overall, the AMDM workshops and annual meeting provided a great opportunity for learning and networking, allowing Beaufort to continue to stay in the forefront with regard to FDA thinking and new industry developments.

Melissa Barhoover, PhD, RAC

Date posted: May 8, 2015

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