mdi Consultants
FDA Seeks Comments on Breakthrough Devices Guidance
On December 13, 2016, the Breakthrough Devices program was added to the Food, Drug, and Cosmetic Act. The program helps patients have more timely access devices and breakthrough technologies that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved alternatives.
The Breakthrough Devices program is an expansion on the Expedited Access Pathway (EAP) Program. It allows future 510(k)s, Premarket Approval Applications (PMA), and De Novo device submissions eligible. This means that any previously granted EAP designations would also be designated as Breakthrough Devices without any separate action being necessary.
A draft guidance for Industry and FDA Staff of the Breakthrough Devices program was recently released by the FDA on October 25, 2017 in order to obtain comments and suggestions. You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov/. Submit written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions about this document regarding CDRH-regulated devices, contact the Office of Device Evaluation (ODE) at 301-796-5550 or [email protected]. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.
When final, this guidance will supersede “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions,” issued
on April 13, 2015.