Medical Devices

PreCert Pilot Program - Frequently Asked Questions

  1. How much time commitment should I expect as part of the pilot?
    We don’t know exactly how much time the pilot will require, as such will depend on variables such as the size of the company and the stage of the product that may be involved.
    We also do not expect the pilot to be a multiyear commitment; we want to learn as much as we can—as quickly as we can.
  2. Could participating ultimately lead to some sort of compliance action?
    If we identify any issue of compliance concern during the pilot, we will discuss it directly with the company, as appropriate.
  3. Can companies outside of the U.S. participate?
    Yes, the PreCert program is open to anyone who is interested in distributing products in the U.S.
  4. Can companies who do not yet have a device on the market participate?
    We are open to companies with products at any phase of development.
  5. Can companies who are in the Pre-510(k)/Pre-Submission process participate?
    Yes. However, we encourage a company that is ready and has urgency to go to market with a product now to engage with the FDA in the traditional manner in addition to participating in the pilot.
  6. My company is in the early stages of start-up, but we’re attempting to get our device to market before the end of the year. We do not have any prior experience or products. Do we qualify for the PreCert program? If we do participate in the PreCert program, will it exclude us from the 510k submission process?
    The PreCert pilot is separate from premarket review. While we encourage you to apply for the pilot, as it is experimental, and there may be much to learn from that experience, if you are already on the path to seeking 510(k) clearance, we encourage you to continue that process instead.
  7. Has CDRH’s Digital Health group collaborated with the software group at CBER that also reviews a number of software products? Are there plans to collaborate with CBER in the future?
    The PreCert pilot is limited to products that would be regulated only through CDRH.
  8. My company is working on submitting an official Statement of Interest. In the statement, do we need to include a description of the quality management system or the plan for real-world data?
    Yes, your Statement of Interest should demonstrate that you meet the pilot’s criteria listed in the Federal Register notice, which includes a description of the quality management system and your company’s plan for real-world data.
  9. I missed the PreCertification webinar. Will the presentation be posted online?
    Yes, the slides and a transcript of the webinar can be found here.
  10. Given the potential to use the traditional regulatory pathways, there will likely be a risk-benefit analysis performed by each company when deciding the best path forward (i.e., using the 510(k) process versus the PreCert program). Do you have an estimate of how long it will take a company to get from entry into the Precert program to final market authorization for products that fall under the PreCert pilot program?
    The PreCert program is separate from premarket review and because it is still being developed we do not have a time estimate.
  11. Can regulated medical devices (Class I and II) that are exempt from 510(k) be included in the pilot, or only those that FDA would have to review and approve to go to market?
    Yes, regulated medical devices that are 510(k) exempt may be included.
  12. When does the pilot program end? What is the last date for companies to apply to participate in the program?
    There is no current deadline for applications— or a set conclusion date.
    We intend to start the pilot by September 1, 2017, but we are limiting participation to nine. We encourage interested participants to apply as soon as possible.
  13. Does FDA have a preferred page limit or format for applicants to use for their submission?
    No, there is not a particular format or page limit that must be adhered to in order to apply. As noted in the Federal Register notice, we will consider the applicant’s Statement of Interest when making our selections.

    FDA will evaluate the statements of interest for participation and select no more than nine participants, who best meet the following:

    1. The company must be developing or planning to develop a software product that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (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. Companies may be traditional medical device manufacturers, or non-traditional device manufacturers

    If your company meets this profile or the selection criteria in the FR notice, the company should email FDAPre-CertPilot@fda.hhs.gov with subject line “FDAPre-Cert: Statement of interest”.

    A typical statement of interest submitted by the company addresses the following points highlighted in the federal register:

    1. Range/Type of products being developed or planning to be developed (e.g. low / high risk) – potentially use IMDRF framework as a reference));
    2. Size of the company (e.g., small /large software development firms); and
    3. Type of the company (e.g. companies that are not considered to be traditional medical device manufacturers, but who intend to make digital health technology or traditional device manufacturers)
    4. Company 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.
    5. While participating in the pilot, the company agrees to:
      1. Provide access to measures described in selection quality number 2, listed previously (KPIs or similar measures).
      2. Collect real-world postmarket performance data and provide it to FDA.
      3. Be available for real-time consultations with FDA.
      4. Be available for site visits from FDA officials.
      5. Provide information about the firm's quality management system.
  14. What type of product is the Precertification Program Pilot looking for?
    At this time we are looking for software products that are being developed, or planning to be developed that meet the definition of a medical device, particularly those products considered to be “software as a medical device.” IMDRF defines “software as a medical device” as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

Page Last Updated: 08/14/2017
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