Which Of The European Regulations For Medical Devices Are Going To Be Adapted By The FDA? - Sponsored Whitepaper

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The FDA is currently reviewing the 510(k) regulations. The current regulations are designed to assure the safety and effectiveness of medical devices. These regulations govern various aspects of the design, clinical evaluation (where required), manufacturing, packaging, labeling (including promotional information), commercial distribution, and post-market surveillance of medical devices. In a memo from 2009, the former (as of March 26, 2010) Director of the Office of Device Evaluation at FDA, Donna-Bea Tillman, stated there is an indication that the FDA is already clamping down on the current 510(k) process by which the majority of medical devices are approved. The Institute of Medicine (IOM) has initiated a study that will address questions including:

"Does the current 510(k) process optimally protect patients and promote innovation in support of public health?"

In 2007, the 501(k) process was used to review 3,052 devices and-approved 2,640 of them. Using the more comprehensive PMA approval process which includes IDE clinical trials, only 27 applications were accepted out of the 41 novel devices submitted. However on the other side of the coin most of the products approved under the 510k process were for improvements in predicate medical device products that were already being used by the medical community.

In The European Community (EC) there is no 510(k) approval process. The regulation and approval of medical devices in the EC are covered under an umbrella of regulations called the Medical Device Directives (MDD). A new medical device directive — 2007/47/EC — was approved, clarifying and updating the current regulations. On account of these regulations, some of the key changes that the FDA will be looking at carefully are:

• Clinical data (in the form of a Clinical Evaluation Report) will be required for ALL devices, regardless of classification. • The entire regulatory data package will need to be collated into a central database and include information on registration, vigilance reports and certificates as well as data relating to clinical investigations. • All medical devices will be classified by their primary mode of action and not by intended use. • Companies will be required to conduct sustained and coordinated clinical post- market surveillance of their products. Under the new directive, the surveillance rules are further tightened. The vigilance system will need to proactively monitor
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