Medical Device Regulation Dilemma

Spotlight on Medical Device Regulation Policies

On 7 February, President Obama gave a speech to the Chamber of Commerce during which he addressed some issues regarding regulations, such as:

We’re improving the way FDA evaluates things like medical devices, to get innovative and life-saving treatments to market faster.

According to the FDA’s device regulation and guidance, medical devices are classified into Class I, II, and III.  Most Class I devices do not require notification.  Most Class II devices require premarket notification 510(k) and most Class III devices must have both 510(k) clearance and receive premarket approval.  In other words, the higher the class, the more stringent the regulatory requirement.  Recent news about medical devices is centered on 510(k).  So what is 510(k)?  From FDA’s website:

The 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

Medical Device Review Standard Challenged

Recently, the FDA has reviewed its 510(k) approval actions, aiming to streamline and shortening review processes.  But there were alarming signs that past review processes already existed flaws that could potentially challenge the FDA’s attempt to simplify medical device review processes. For instance, the New York Times reported that in the past five year there were over 68 recalls and more than 22,000 reports of malfunctioning external defibrillator devices.  This prompted the FDA’s advisory panel to request tighter oversights.  A study also found that about 70% of the recalled devices received FDA abbreviated agency protocol review, which again alerts current regulatory processes.  Despite these seemly increasing numbers of recalls and defective devices, medical device makers complained that the FDA’s stricter and prolonged regulatory scrutiny had already forced them to move operations to overseas, like China, Brazil, India, and Europe.  Again FDA is sandwitched between medical device makers who prefer simpler approval processes and consumers who demand stricter standards and safer devices.  A tough role.

Greenlights on Recent Medical Devices

From my Google Alert notice, at least four companies received greenlight on their 510(k) clearance and approval, here they are (and hope more to come):

1. Diazyme’s 25-Hydroxy Vitamin D Assay (January 24, 2011)

2. Pacific Consolidated Industries’s On-Site Oxygen Generators (February 7, 2011)

3. Depuy Orthopaedics’s New Titanium Foam Implants and revision hip system (February 15, 2011)

4. Allergan’s Lap-Band Device (February 16, 2011)

Until next post, keep on reading and writing!!


About fdabiomed
I like to read, organize, and write about biomedical related topics. I am passionate to learn new things, particularly news related to the Food and Drug Administration's decision and announcement, as well as the decision impacting on company's stock price.

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