"Unpredictable" is one term devicemakers have used to describe the premarket approval and de novo submission process with the FDA. But now, a ray of hope for some clarity. The agency has published guidance for manufacturers detailing how the risks and benefits of certain medical devices are considered during premarket review.
As a result of the guidance, manufacturers will have a tool explaining what the agency considers during the review of PMA applications for high-risk medical devices, as well as for de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices.
The guidance names the factors the agency considers when assessing potential benefits; these include the extent of the benefits as well as duration of effect. However, these benefits will be balanced against potential risks--whether serious or non-serious--as well as the risk of false-positive or false-negative results in the case of diagnostics.
In addition, the agency assesses whether alternatives are available, if risk-mitigation schemes (such as labeling to restrict the indication) should be employed, the need for post-marketing studies, and if an unmet need will be met with 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," explained CDRH Director Jeffrey Shuren.
CDRH will train medical officers, as well as update staff managers and device reviewers, on the guidance to assure it 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 May 1.
- see the FDA release
- get the guidance (PDF)