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FDA scrutinizes 510(k) premarket clearance process for medical devices

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WASHINGTON — The U.S. Food and Drug Administration is re-examining its 510(k) premarket clearance process for medical devices. A public meeting on the process was held Feb. 18.

The 510(k) process, introduced in 1976, requires that a device be "substantially equivalent" to a predicate device, one that was approved before the process was enacted. The FDA is considering possible updates to the process in light of burgeoning technological developments.

"It has been more than 30 years since the establishment of the premarket notification process for medical devices," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health (CDRH), said in an FDA press release. "We are looking forward to hearing from the public on issues related to this program to help us improve it."

The regulatory process must keep pace with evolutionary changes to medical devices, Donna-Lee Tillman, PhD, MPA, director of the FDA's Office of Device Evaluation, said at the public meeting.

"As science evolves, our regulatory approach also needs to evolve," she said. "We need to be continually assessing the regulatory framework for the review of medical devices to ensure that it is still accomplishing our fundamental mission - to promote and protect public health."

Heather S. Rosecrans, director of the 510(k) staff at the CDRH's Office of Device Evaluation, noted the importance of ensuring that device regulations are clear and consistent.

"Developing clear definitions, guidance and additional authorities may be required," Ms. Rosecrans said. "Utilizing rational application of guiding principles is vital."

Presentations from the meeting are posted at www.regulations.gov, Docket No. FDA-2010-N-0054. Electronic comments may be submitted to the docket. Written comments may be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The deadline for all submissions is March 5.

An agency task force is scheduled to announce recommended policy changes in June.

The Institute of Medicine is scheduled to release a report on device regulation next year, according to an FDA press release.