Mediqol

Legislation has recently been introduced into Congress that would provide more power to FDA to inspect both domestic and foreign device manufacturers facilities.

The legislation, which was introduced by US senators Charles Grassley and Ted Kennedy, also suggests commissioning a stuffy to examine the FDA’s system for approving medical devices.

It will be very interesting to see if the 2009 version of this legislation called the Drug and Device Accountability Act makes progress as it will:

•    expand the FDA’s authority to inspect foreign manufacturers

•    allow the FDA to issue subpoenas and to detain devices where inspectors believe the product is misbranded

•    require companies submitting device applications to certify that the application complies with applicable regulations and is not false or misleading

Senator Grassley told senate that he hoped the legislation would help to resolve issues he had encountered with the FDA namely; the quashing of scientific opinion within the agency, delays in informing the public of emerging safety problems and too cosy a relationship between the FDA and the industry.

“Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work,” Senator Grassley said on April 23.

Does anyone know the likely timetable for approval of this legislation?