White Paper on the FDA's Importer Guidance for Medical Device Manufacturers is Issued by AssurX

The leader in quality management and regulatory compliance solutions, AssurX, Inc., has released a white paper titled: “FDA Importer Guidance For Devices: Guidance on Good Importer Practices signals 2009 will be a year of a more focused, active agency” for the medical device industry. This complimentary white paper throws light on the part of a broader effort by the FDA to place more responsibility for quality control on manufacturers and the agency’s roadmap for producing safer products.

Background: The FDA has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug and food recalls.

Off the record, current and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

Now with a new president and renewed focus on government regulation in Washington, it’s likely pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.

The public comment period for the “Good Importer Practices Draft Guidance” is April 12, 2009.

http://www.assurx.com/FDAImporterGuidanceWhitePaper.html