Federal Policy Advocacy Alert: May 9, 2014
Friday, May 9, 2014
Posted by: Stephen Rapundalo
FDA Seeks Company Partners for Experiential Learning Program
FDA's Center for Devices and Radiological Health (CDRH) is seeking interested organizations to participate in the Experiential Learning Program (ELP).
The ELP provides a formal training mechanism for CDRH's regulatory review staff to visit research, manufacturing, and clinical facilities to observe firsthand how medical devices are designed, developed, and utilized.
This opportunity to observe the device development life cycle will provide review staff a better understanding of the medical devices they review, and the challenges faced throughout development, testing, manufacturing, and clinical use. On May 1, 2014 we issued a Federal Register Notice inviting medical device manufacturing and clinical facilities to participate in this formal training program for CDRH review staff.
The Federal Register Notice describes the ELP, the current areas of focus, the types of facilities we are seeking, and the process for applying can be found online here
Requests to participate in the ELP must be submitted by Monday, June 2, 2014. The request should include a description of your facility relative to CDRH product areas of interest and must identify the docket number FDA-2013-N-0338-0047.
Requests maybe submitted either electronically on the Regulations.gov website
, or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852.
If you have questions about the ELP Program, please contact: Latonya Powell at
FDA Reports on Approval Times
FDA Commissioner Margaret Hamburg wrote
in the FDA's official blog, FDA Voice, about study results examining trends in drug approvals and approval times by FDA and its regulatory counterparts in Europe and Japan. The study found FDA to be consistently faster in its new drug approval times, and reported new data indicating that the Agency's medical device division is on track to meet its commitments under the most recent Medical Device User Fee Act (MDUFA)
Drug Safety Oversight Board Policies Issued
FDA's Center for Drug Evaluation and Research (CDER) released a Manual of Policies and Procedures (MAPP) entitled "Drug Safety Oversight Board (DSB)." This MAPP
describes the organizational structure, roles, and responsibilities of the DSB and its staff.
FDA Issues Report on Medical Device Inspections
FDA issued a report
on medical device inspections that showed foreign medical device manufacturers make up a disproportionate number of process and quality violations that result in formal warning letters. Foreign firms make up 40% of manufacturing violations that result in warning letters, even though they only make up 10% of inspections.
Members of the Senate Health, Education, Labor and Pensions (HELP) Committee sent a letter
to FDA Commissioner Margaret Hamburg expressing significant concern about the Agency's use of draft guidances to make substantive policy changes. The letter notes draft guidances are becoming default FDA policy, despite the fact they are issued for comment purposes only - see article in FDA Law Blog
MichBio Joins in Co-Hosting Congressional Briefings on NIH
A group of regional life science trade associations including MichBio will conduct Congressional briefings on "Public-Private Partnerships - Advancing Treatments and Cures." Two briefings are planned, one each for the House and Senate, on May 20. Guest speakers will include representatives from NIH, academia, industry (BD's Accuri Cytometer will be featured) and patient advocacy. The sessions are meant to educate staff and elected officials about the benefits of partnership with NIH and the positive outcomes that public funding for life science research mean to patients. Rep. Fred Upton (R-6th), Chair of the House Energy & Commerce Committee is a co-sponsor of the House briefing that will be held in one of the E & C Committee rooms.
Changing Landscape for Medical Device Regulation
Read an article
authored by NSF Health Sciences
that discusses the challenges facing the quality professional as regulation of the medical device industry intensifies, particularly in Europe.