On May 22 the FDA posted a call for test cases to participate in the 2019 Digital Health Software Precertification (Pre-Cert) Program Test Plan (see my previous post here). They are looking for volunteers who expect to submit traditional 510(k) marketing submissions in 2019 and are representative of the following groups:

• 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.

Companies who volunteer need only submit a statement of interest via email and will be assessed against the 5 selection criteria listed in the notice. The agency will not be provide precertification for companies during the test plan – this is a data collection exercise only. It is, however, an excellent opportunity to participate at an early stage of an exciting new program and growing industry.

Text Copyright © 2019 Katrina Rogers