FDA helps provide clarity on developing new drug products in age of individualized medicine
The U.S. Food and Drug Administration (FDA) announced it is introducing a new, voluntary program for certain medical devices and device-led combination products 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 mission to protect and promote public health, the 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."
