U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Safer Technologies Program for Medical Devices
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Safer Technologies Program for Medical Devices Guidance for Industry and Food and Drug Administration Staff January 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-4048
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center 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 classification request ("De Novo request"), or premarket notification (510(k)), taking into account the specific eligibility factors described in this document. 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 Novo marketing 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 (DDPs), sprint discussions, and senior management engagement.

For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus 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 the Center for Biologics Evaluation and Research."

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 this guidance. FDA does not intend to accept requests for inclusion in STeP within this time period.

1 A 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.

2See section 1003(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Submit Comments

Submit Comments Online

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:

Dockets Management
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.

Back to Top