FDA Proposes New Guidelines To Make Some Medical Devices Safer

Federal health officials have issued a new draft guidance to improve the safety and availability of medical devices used to treat serious and potentially life-threatening diseases or conditions.

The U.S. Food and Drug Administration (FDA) issued a draft guidance for the Safer Technologies Program for Medical Devices this month, which would fast-track the pre-market approval process for medical devices used to treat serious conditions not eligible under the Breakthrough Device Program.

Officials said the Safer Technologies Program (STeP) initiative is intended to help patients have more timely access to medical devices and device-led combination products by expanding their development, assessment, and review.

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Medical devices qualified under the voluntary program will include those reasonably expected to significantly improve the safety of currently available treatments for diagnostics targeting underlying diseases or conditions associated with mortality.

The guidance states the statutory standards for premarket approval of these medical devices will be maintained, however the agency will be providing additional resources to help finalize products for market and patient use.

Similar to the Breakthrough Device Program which was created by the FDA to give patients more timely access to devices being developed to effectively treat or diagnosis life-threatening or irreversibly debilitating diseases or conditions, STeP will be offering a similar fast-track program for medical devices that do not qualify for the Breakthrough Device Program.

The program will offer manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics that will be addressed during the premarket review phases. These qualifying devices are also granted a prioritized review after being submitted for market approval to the FDA.

Often, medical devices can be held in the pre-market approval process while the FDA evaluates and ensures the safety for public use. Revisions of devices once ruled upon by the FDA can also cause significant delays in devices entering the market for medical use. The FDA claims that by allowing manufacturers a timely means of communication with FDA regulatory officials, devices that could save lives may be able to reach the hands of healthcare professionals and patients faster.

The FDA is accepting written documents to Docket Number FDA-2019-D-4048 until November 18, which can be sent to :

Dockets Management

Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852


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