The Food and Drug Administration (FDA) has announced that it will open a public docket and
receive public comments in response to a report from the Institute of Medicine
on the 510(k) program.
According to a news release, the FDA commissioned the Institute of
Medicine (IOM) report in September 2009 in response to concerns raised by its
stakeholders. The report was part of efforts to determine what — if any
— changes should be made to improve the 510(k) program. None of the
IOM’s recommendations are binding, but the FDA plans to hold a public
meeting in the near future to foster discussion.
“We appreciate the IOM’s report on the 510(k) program, and
agree that the public should continue to feel confidence in the medical devices
on the market today,” FDA Center for Devices and Radiological Health
Director Jeffrey Shuren, MD, stated in an FDA release. “The 510(k) program
has helped support a robust medical device industry in the United States and
has helped bring lower-risk devices to market for the patients who need
The statement also noted that while the FDA believes the 510(k) process
should not be eliminated, it is open to additional proposals and approaches for
improvement of the device review program.
According to the release, the 510(k) program is the most common pathway
to market for lower-risk medical devices. In order for a manufacturer to begin
marketing a device subject to 510(k) review, the FDA must clear a 510(k)
premarket notification demonstrating the new or modified product is
substantially equivalent to another legally marketed “predicate”
Congressional action will be required if some of the IOM’s
recommendations — such as the design of a new regulatory framework for
class II (moderate risk) devices — are to be followed, but the FDA noted
in the release that it plans to continue its review of the report and further
solicit input from stakeholders regarding recommendations in the report that
involve existing FDA authorities.
The IOM noted in a brief that it has found the current 510(k) process
flawed based on legislative foundation.
“Rather than continuing to modify the 35-year-old 510(k) process,
the committee concludes that the FDA’s finite resources would be better
invested in developing an integrated premarket and postmarket regulatory
framework that provides a reasonable assurance of safety and effectiveness
throughout the device life cycle,” as written in the brief, which added
that this framework should, among other things:
- Be self-sustaining and self-improving;
- Ensure the life-long safety and effectiveness of medical devices
through use of relevant and appropriate regulatory authorities; and
- Be risk-based.
The FDA has also committed to a plan designed to improve the 510(k)
program and other device review programs.
“Many of the IOM findings parallel changes already underway at the
FDA to improve how we regulate devices,” Shuren stated in the release.
“These actions, plus a sufficiently funded device review program, will
contribute to a stronger program.”
Actions completed as a part of this plan include the issuance of a draft
guidance to clarify when manufacturer changes to a 510(k)-cleared device
already on the market warrant a new 510(k) submission. The FDA has also begun
addressing all outstanding “pre-amendment” Class III device types
subject to 510(k) review.
Actions the FDA noted in the release that it will seek to complete in
the near future include:
- The issuing of a draft guidance to strengthen and streamline the
“de novo classification” path to market for novel low- and
moderate-risk devices that are not substantially equivalent to an existing
- The drafting of a “510(k) Paradigm” guidance to clarify
certain aspects of the FDA’s 510(k) substantial equivalence review; and
- The issuing of a proposed rule on Unique Device Identifiers this
fall — a move which the IOM noted would be a meaningful change to the
agency’s postmarket capability.
For more information:
Institute of Medicine. Medical devices and the public’s
health: The FDA 510(k) clearance process at 35 years. Accessed on July 29,