ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

Key Takeaways from New FDA Guidance on Off-the-Shelf Software

As the number of medical devices that include software continues to grow, so too does the use of off-the-shelf (OTS) software in regulated medical devices. Defined as “a generally available software component used by a device manufacturer for which the manufacturer cannot claim complete software life cycle control (e.g., operating system, printer/display libraries),” OTS software has its own regulatory/quality considerations and deliverables when incorporated into a medical device.

Could Your Company Benefit from FDA’s Q-Submission Program?

FDA’s approach to regulating medical devices can sometimes be confusing and overwhelming. Thankfully, there is a voluntary program, The Q-Submission Program, that device manufacturers (also called sponsors) can use to obtain FDA feedback during device development, submission review, or even prior to clinical study commencement.

FDA Demands Greater Level of Software Documentation in New Guidance

Software as a medical device (SaMD) has evolved rapidly in the past 20 years, and the FDA has responded with a new final guidance for the content of premarket submissions for device software functions. This guidance calls for a substantially greater amount of documentation than was required by the 2005 version — an especially important point for companies that file infrequently with the FDA.