FDA CDRH Office of Device Evaluation’s “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices”.This defines submission requirements for information related to use of off-the-shelf software used as part of a medical device. It does not apply directly to production and quality system software.
Pocket booklets of this guidance are available from SoftwareCPR for $3 apiece up to 3 copies and $2 a piece for each copy over 3. Just send email to firstname.lastname@example.org and include contact information so we can arrange shipment and payment.
SoftwareCPR keywords: OTSS, COTS, Software submissions