MITA Comments on FDA Software Precertification Pilot Program

On September 13, 2017, MITA submitted comments on FDA Docket FDA-2017-N-4301, Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program. MITA commends the Agency for taking proactive steps in considerations for regulatory review of software products. Additionally, the comments include a set of essential tenets for the software precertification program, which MITA jointly developed with other stakeholders. Click here to view our letter.