Archive for May, 2009
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?
Should the EMEA have medical device regulatory over-sight?
I’ve been catching up on my regulatory reading lately and I’ve come across an article from a device consultant recommending that the European Medicines Agency (EMEA) gets involved in medical device regulatory over-sight (http://tinyurl.com/qghar4). We’ve had a bit of a chat about this internally and we aren’t so sure. Where would it lead? What impact would it have on device approval timelines? What expertise do EMEA have in device approval?
We think the medical device regulatory environment in Europe faces challenges and changes need to be made but we don’t think this is the solution.
New Brazilian Regulatory Requirements
The Brazilian Regulatory Agency, ANVISA, has recently officially published RDC 25/09 which calls for Brazilian companies (manufacturers, distributors or local agents) registering products in risk class III and IV (medical devices and equipment) and risk class II, III and IIIa (products for in-vitro diagnostics) to request GMP certificates from the device manufacturers (local and international) otherwise the company will not be allowed to register these categories of product in Brazil.
The GMP certificate issued by ANVISA is a mandatory item on the check-list of documents for registration for these products and will be issued after an audit of the respective plant/manufacturing site. Manufacturers will need to pay ANVISA’s fees for the GMP inspection (we are still seeking clarification on these fees) and submit a request for a GMP inspection by ANVISA staff. At this stage we aren’t sure if this is going to lead to a delay in product approvals but we’ll keep you posted with feedback from our client base.
For assistance with registering your products in South America please contact our International Product Registrations expert at sarah.ramsay@mediqol.com
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.
European Notified Bodies look to strengthen system
Read an interesting article lately that associations representing the majority of European Notified Bodies are working hard to finalise a paper outlining how they plan to strengthen their oversight of medical device manufacturers. This would appear to be in response to the European Commission’s proposed recast of the medical device directives but is the move too late, will it go far enough and how will it work given the diversity of the notified bodies? An issue we’ll definitely be keeping an eye on.
