FDA Publishes “First-of-a-Kind” Guidance for Medical Device Premarket Approval and De Novo Decisions

Mar 30, 2012   

On March 27, 2012, the U.S. Food and Drug Administration (“FDA”) published a “first-of-a-kind” guidance document for industry and FDA staff entitled, “Guidance for Industry and Food and Drug Administration Staff:  Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Determinations” (the “Guidance”). The Guidance is meant “to provide greater clarity for FDA reviewers and industry regarding the primary factors the FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices.” According to Jeffrey Shuren, M.D., director of FDAs Center for Devices and Radiological Health (“CDRH”), “[t]his 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.”

The factors explained in the Guidance are applicable to devices subject to premarket approval (“PMA”) applications or de novo classification petitions. Under section 513(a) of the Food, Drug, and Cosmetic Act (“FDCA”), a PMA is the FDA process of scientific and regulatory review to evaluate the safety and efficacy 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 FDCA requires that FDA determine whether a PMA application provides a “reasonable assurance of safety and effectiveness” by “weighing any probably benefit to health from the use of the device against any probable risk of injury or illness from such use,” among several other factors. Pursuant to section 513(f)(2) of the FDCA, a de novo petition is available to sponsors of low to moderate risk medical devices that have been determined to be not substantially equivalent (“NSE”) through the 510(k) program.

According to the FDA, the Guidance:

  • Outlines the systemic 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; and
  • Describes an approach that takes into account patients tolerance for risks and perspectives on benefits, as well as the novelty of the device.

In an effort to bring much needed clarity and consistency to the review and decision-making processes for PMA and de novo submissions, the Guidance provides worksheets that the FDAs reviewers will use in making the benefit-risk. Additionally, the worksheet analysis will be described in the Summary of Safety and Effectiveness Data for PMAs and in the decision summary review memos for de novo decisions. The FDAs press release for the Guidance states, “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.” The factors outlined in this Guidance will be applied to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1, 2012.

This Guidance only applies to PMA and de novo submissions but does not address any benefit-risk determination in the 510(k) decisions. We will continue to monitor the FDA to determine if it will be apply a different or the same standards in 510(k) decisions. For more information about the regulation of medical devices, including the submission of a 510(k), PMA, or de novo petition, please contact us at contact@fidjlaw.com or (305) 350-5690.