Is Quicker Really Better? The Overhaul of the 510(k) Process

By: Melissa M. Turczyn

On January 19, 2011, the Food and Drug Administration (the “FDA”) announced 25 steps it intends to take before year end to improve the agency’s 510(k) clearance program for medical devices. The purpose of the program is to allow medical devices to be marketed if the applicant can show that the device is substantially equivalent to a device already on the market.

In recent years, the FDA has come under increasing scrutiny by both medical device companies and outspoken critics who claimed the current process was inconsistent and slow, and has resulted in unsafe devices being cleared. The newly released action items, selected from a broader group which included more controversial proposals, are intended to speed along the approval process for medical devices (with most devices being cleared in roughly five months), while maintaining a commitment to public safety.

Action Items to be Completed before December 31, 2011:

1.The FDA will create Draft Guidance for each of the following, beginning June 15, 2011:

a. 510(k) Modifications;

b. Clinical Trials;

c. Evaluation of Automatic Class III Designations (De Novo);

d. Standards;

e. Appeals;

f. 510(k) Paradigm;

g. Pre-Submission Interactions; and

h. Product Codes.

2.  Beginning March 31, 2011, the FDA will modify certain internal and administrative matters, including the establishment of a Center Science Council, the enhancement of training provided to its internal staff and the development of a network of external experts to leverage scientific expertise found in the outside marketplace.

3.  Also beginning March 31, 2011, the FDA will begin certain programmatic and regulatory initiatives to implement new programs and improve existing processes. For example, a public meeting will be held on April 7th and 8th to provide additional information about the viewing of device photos in a public database without the disclosure of any unique proprietary information of the devices.

The Institute of Medicine (the “IOM”) is also conducting an independent evaluation of the process and will provide feedback to the FDA on certain controversial issues, including the scope and grounds for rescinding a 510(k) clearance, providing greater authority for postmarket surveillance, and providing clarification on when a device should no longer be available for use as a predicate.

Although early commentators are encouraged by the proposed changes, the action items are still only proposals, meaning the final look and operation of the 510(k) clearance process remain to be seen.


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