FDA NEWS RELEASE
For Immediate Release: March 27, 2012
Media Inquiries: Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
New FDA guidance on considerations used in device approval, de novo decisions
Clinical data, risks, benefits and patient risk tolerance outlined in process
The U.S. Food and Drug Administration today published a first-of-a-kind
guidance1 for medical device manufacturers, describing how the benefits and
risks of certain medical devices are considered during pre-market review.
Premarket approval (PMA) is the FDA process of scientific and regulatory review
used to evaluate the safety and effectiveness of Class III medical devices.
Class III devices are those that support or sustain human life, are of
substantial importance in preventing impairment of human health, or which
present a potential unreasonable risk of illness or injury. The de novo process
is available for low- and moderate-risk devices that have been found not
substantially equivalent (NSE) to existing devices.
When evaluating PMA applications or de novo petitions, the FDA relies upon valid
scientific evidence to assess safety and effectiveness. Both clinical and
non-clinical data play a role in FDA’s benefit-risk determinations.
The guidance includes a worksheet for device reviewers that incorporates the
principal factors that influence benefit-risk determinations, such as the type,
magnitude and duration of a risk or benefit, the probability that a patient will
experience the risk, patient tolerance for risk, availability of alternative
treatments, and the value the patient places on treatment.
outlines the systematic approach FDA device reviewers take when making
benefit-risk determinations during the premarket review process
provides manufacturers a helpful tool that explains the various principal
factors considered by the agency during the review of PMA applications, the
regulatory pathway for high-risk medical devices, and de novo petitions, a
regulatory pathway available for novel, low- to moderate-risk devices
describes an approach that takes into account patients’ tolerance for risks and
perspectives on benefits, as well as the novelty of the device.
"This guidance clarifies this process for industry, which will provide
manufacturers with greater predictability, consistency and transparency in FDA
decision-making while allowing manufacturers and the FDA to use a common
framework for benefit-risk determinations," said Jeffrey Shuren, M.D., director
of FDA’s Center for Devices and Radiological Health (CDRH).
The FDA will also increase the transparency of the decision-making processes by
describing the worksheet analysis in the Summary of Safety and Effectiveness
Data for PMAs and the decision summary review memos for de novo decisions.
"In addition to bringing clarity to our decision making for industry, this
guidance will provide our reviewers with uniform and consistent guidelines to
assess probable benefits and risks," said Shuren.
CDRH will train medical officers, review staff managers and device reviewers on
the guidance to assure the guidance is applied consistently to submissions and
petitions. CDRH reviewers will begin applying the guidance to incoming PMA and
de novo submissions and to submissions already under review with decisions
beginning on May 1.
The FDA is also developing external training modules to help industry and device
sponsors understand how CRDH will apply the guidance.