Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products. Specifically, a number of device types will now be exempt from premarket notification requirements.
The move, which affects 30 medical device types ranging from blood testing to radiology film processors, was prompted by the long track record of safety and effectiveness of each respective product. CDRH director Jeffrey Shuren stated that “the agency is taking a smart regulatory approach that eases unnecessary requirements for manufacturers,” without risking the health of the public in the process. The FDA has also stated that this is the first step in what will be a gradual loosening of 510(k) requirements across the board for low-risk radiology and in vitro diagnostic devices.
There is no question that exempting so many medical device products from premarket notification will do more than just “ease” the burden for device makers – it will also go a long way towards freeing up additional FDA resources and allow for greater regulatory attention to be focused in areas where it has been perceived as lacking (innovative high tech products, for example). Despite the 510(k) change, the FDA will still require that each device meet GMP and Quality System regulations.
The FDA has published a guidance document that explains the Administration’s position on the relaxing of 510(k) review for the affected medical device types. Eventually, the plan is for Class II devices implicated in the change to have their status revised to Class I, with Class I devices then undergoing a further revision of their own classification regulations. Until this occurs, the FDA will exercise what it calls “enforcement discretion” in handling premarket notification submissions for the 30 medical device types described within the document. There is as of yet no timetable for the adoption of this dramatic shift in medical device regulatory approval standards, but a 90-day comment period on the proposal is currently in effect.
Benjamin Hunting, MDCI Blogging Team
August 10, 2011
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- FDA premarket notification rules for radiology medical devices may change (medcitynews.com)
- Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs (earlsview.com)
- FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units (earlsview.com)
- FDA Asked To Reexamine Approval System after 35 Years (health-insurance-carriers.com)
- Sadwin gets to the heart of the Issues with FDA 510(k) (earlsview.com)
- IOM Gives FDA The wrong prescription on medical devices & 510(k) (earlsview.com)
- FDA Seeks Public Views on Proposed 510(k) Plans (earlsview.com)
- FDA medical device review times to be subject of House hearing (earlsview.com)
- 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)