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.
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.
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.
This short, 6-page guidance casts a long shadow across the medical device landscape. The guidance states that the agency will reject an application that fails to provide adequate cybersecurity measures in premarket applications — just one of several recent developments that show just how serious the U.S. federal government is about cybersecurity.
Several features of this draft suggest companies will have to do a significant amount of work in the premarket phase for development of a predetermined change control protocol (PCCP), making the development process potentially lengthier and more expensive.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
