The FDA is seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter to meet the goals of the Test Plan.
To ensure that the entire Pre-Cert framework is appropriately evaluated, the FDA intends to prioritize selection of premarket submissions (510(k) submissions or De Novo Requests) that will enable evaluation and testing of all four components outlined in version 1.0 of the Working Model. Recognizing the need to test the Pre-Cert model against a diverse set of test cases, the FDA is looking for volunteer cases to represent a broad spectrum of software developers:
- Small and large software development firms;
- Companies that develop a range of products, including both low- and high-risk SaMD; and
- Companies that are not considered to be traditional medical device manufacturers but who intend to make SaMD.
Who can volunteer test cases: The FDA is interested in conducting Excellence Appraisals with Software as a Medical Device (SaMD) sponsors who expect to submit traditional marketing submissions in 2019 or shortly thereafter to inform the development of the Pre-Cert program as the FDA seeks to validate the Software Pre-Cert Pilot program. The FDA does not intend to provide precertification for companies during the testing in 2019.
How to volunteer: To be considered for the voluntary Software Pre-Cert Test Plan, submit a statement of interest for participation to FDAPre-CertPilot@fda.hhs.gov.
Selection Qualities: The FDA intends to select test case participants on a rolling basis, based on the CDRH resources and availability to conduct Excellence Appraisals during the dates the companies are available. The FDA will select participants who best match the following selection qualities:
- The company plans (anticipated timing of the submission) to submit a De Novo Request or 510(k) submission for 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)) prior to June 2020.
- The organization volunteering for the test plan is in good standing and does not have any outstanding FDA compliance actions.
- 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 or other similar measures.
- While participating in the Test Plan, the company must agree to the following items, which are described in greater detail in the Working Model (v1.0):
- Provide access to measures described in selection quality number 3, listed previously (key performance indicators or similar measures).
- Collect real-world postmarket performance data and make it available to the FDA.
- Be available for real-time consultations with the FDA.
- Be available for Excellence Appraisal site visits from the FDA.
- Provide information about the firm's quality management system.
- The company provides dates that it expects to be ready and willing to participate in an Excellence Appraisal and participates in the planning of the Excellence Appraisal site visit in 2019.
The FDA may also consider, resources and time permitting, organizations willing to test individual components of the program, such as Excellence Appraisal, a review determination, or real-world performance analytics.
What to expect after you submit a statement of interest: The FDA will, on a rolling basis, notify companies accepted as Test Cases.