FDA-CDRH Seeks Greater Authority to Regulate Medical Devices

Feb. 27, 2010 - PRLog -- On February 18, 2010 the U.S. Food and Drug Administration (FDA) officials announced that it is considering approaching Congress for greater authority over the medical-device industry.  This move comes as the FDA works with industry representatives to alter and strengthen the 510k medical device approval process.

FDA officials at the Center for Devices and Radiological Health (CDRH) who oversee the agency's medical-device approval system believe the agency’s powers are too narrow when it comes to instituting medical devices recalls,  oversight of devicemaker labeling, post-market surveillance, and other program areas.  

The FDA’s 510k approval process is generally used when a company wishes to promote a new, moderate-risk, medical device, also known as Class II or Class III devices.  Through the 510k submission, the submitter provides CDRH with data to demonstrate “substantial equivalence” to another legally marketed device, or, in other words new devices must at least be as safe and effective as the predicate medical device.   The  510k process requires the compilation of a detailed product and manufacturing information including Quality System Regulations (QSRs) and Good Manufacturing Practices (GMP) reporting; product design date; quality and assurance statistics; and/or verification reports, among others.    

FDA’s concerns over medical device regulation are contributed  to the notable a number of high-profile safety problems with heart defibrillators, contact lens solution and other products which raised public anxiety. Although critics say the FDA’s 510k accelerated process is too widely used and leads to increased problems after devices are sold, devicemakers worry that increased regulatory oversight by CDRH will inevitably  lead to longer review times, higher costs and other hurdles that will make it harder to bring new medical devices to market.

The threat of greater regulation will affect all players in the medical device industry, from small distributors to large multi-national manufacturers.

For more guidance on how to bring a new medical device to market in the United States, please contact Ann Marie Gaitan, Esq., at amgaitan@gaitanmorales.com.  Ann Marie Gaitan, Esq.  is a partner at Gaitan Morales, PLLC, and dedicates her legal practice to providing specialized regulatory and corporate legal representation to clients in the food, drug, device and cosmetic industries. For more information, please visit the Gaitan Morales website at: www.gaitanmorales.com.

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About Gaitan Morales, PLLC: Gaitan Morales, PLLC is a boutique law firm dedicated to serving the needs of clients in the food and dietary supplement, drug, cosmetics, and medical device industries. Gaitan Morales, PLLC, your regulatory and business partners.