Posts Tagged ‘FDA’
FDA promises tighter enforcement action
In a 6 Aug press release FDA Commissioner Margaret Hamburg outlined how the FDA is implementing a five point strategy to improve their effectiveness system – http://bit.ly/3mEH0x
The plan involves setting post inspection deadlines, speeding up warning letters, the prioritization of enforcement issues and quicker action being taken against infringers. The agency will also introduce a formal warning letter close out process to make it clear when remedial action has been taken satisfactorily.
Tighter device legislation in the US?
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?
FDA notice on pre amendment Class III devices
The Food and Drug Administration recently notified manufacturers of 25 different types of Class III medical devices, all marketed prior to 1976 for which PMA’s have not been issued, that further information on their safety and efficacy will be required by 7 August. The FDA is considering whether the products should be subject to a pre-market approval application (PMA) or indeed whether they should be down classified to Class I or Class II.
Here’a link to the FDA news release (http://tinyurl.com/fdapreammend)
It will be very interesting to see if any of these products which have obviously been on the market for a long time are required to go through the PMA process.
