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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products1 that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classificationrequest ("De Novo request"), or premarket notification (510(k)). Consistent with the Agency's statutory mission2 to protect and promote public health, FDA believes that this "Safer Technologies Program" or "STeP" will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novomarketing authorization, and 510(k) clearance. FDA has modeled STeP on the principles and features of FDA's Breakthrough Devices Program as mandated in section 515B of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360e-3) and further described in the FDA guidance document entitled "Breakthrough Devices Program" (hereinafter referred to as the "Breakthrough Devices Program guidance document"). As resources permit, FDA intends for STeP to incorporate similar features offered under the Breakthrough Devices Program, such as interactive and timely communications, early engagement on Data Development Plans (DDP), prioritized review, and senior management engagement.
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of standards in regulatory submissions, please refer to the FDA guidance titled "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices" and "Standards Development and the Use of Standards in Regulatory Submissions Reviewed in CBER."
FDA recognizes and anticipates that the Agency may need up to 60 days to perform activities to operationalize this Safer Technologies Program following issuance of the final guidance. FDA does not intend to accept requests for inclusion in STeP within this time period.
1A combination product is defined in 21 CFR 3.2(e). For purposes of this guidance, device-led combination products refer to combination products subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-4048.