The FDA is Currently Accepting Requests for Participation in a New Precertification Pilot for Medical Software Developers

As of August 1, the U.S. Food and Drug Administration began accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017.  The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products.  The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.

In a Notice submitted by the Agency on July 27, the FDA began by acknowledging that the Agency’s “traditional approach to … higher risk hardware-based medical devices is not well suited for the faster iterative design, development, and type of validation used for software products.”  The goal of the pilot program is to develop precertification criteria for software companies that engage in high-quality validation and ongoing support of their products.  The purpose of such a precertification program would be to:

1.              Obviate the need for premarket submissions for certain products;

2.              Lessen the required content when premarket submissions are required; and/or

3.              Allow for faster review of marketing submissions for certain products.

In summary, the Notice states that the purpose of the precertification pilot is to “develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices.”

Digital health and medical software development companies interested in participating in the program must submit a Statement of Interest for Participation to by August 31, 2017.  The Statement of Interest should address the following program participation selection qualities:

1.              The company must be in the process of developing or planning to develop a software product that meets the definition of a “device” at 21 U.S.C. § 321(h).*

2.              The company has an existing track record in developing, testing, and maintaining software products demonstrating a culture of quality and organizational excellence measured and tracked by Key Performance Indicators (KPIs) or other similar measures.

3.              While participating in the pilot, the company agrees to:

(a)          Provide FDA access to the KPI or other measures used;

(b)          Collect real-world post-market performance data and provide them to the FDA;

(c)           Be available for real-time consultations with the Agency;

(d)          Be available for site visits from FDA officials; and

(e)          Provide information on the company’s quality management system.

The full Notice [82 FR 35216] is available here.

            If you have questions about FDA medical device regulation and how Agency regulations and policies may impact your digital health product, please contact Nixon Law Group


* “[D]evice … means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”