Proposal to restrict 510(k) submissions sparks debate

02/29/2012 | Bloomberg

A House bill introduced this month that would allow the FDA to refuse 510(k) submissions with designs based on previously recalled products has incited debate between the industry and regulators. Jeffrey Shuren, director of the FDA's device center, said the bill would close a "loophole" that has called into question certain medical device approvals. The Advanced Medical Technology Association, however, maintains the bill would put more strain on companies already facing lengthy delays in FDA reviews, spokeswoman Wanda Moebius said.

View Full Article in:

Bloomberg

Published in Briefs:

SmartBrief Job Listings for Health Care

Job Title Company Location
Product Development Manager, Disposable Medical Products
ASAHI INTECC, Orange County CA R&D Center
Santa Ana, CA
Neurovascular Intervention Product Sales Rep, North East
ASAHI INTECC
Multiple Locations, SL_Multiple Locations
Vice President of Regulatory Affairs
Pentec Health
Boothwyn, PA
Sr Coordinator Clinical Research (US/TA/00/0073/SL) - 1400000AQX
Abbott
Santa Clara, CA
Senior Director, Biostatistics
Edwards Lifesciences
Irvine, CA