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.
Additive manufacturing (AM) held a prominent place in the response to the COVID-19 pandemic, which was explicitly acknowledged by the FDA. The agency collaborated with other federal government agencies to encourage rapid innovation in manufacturing for the pandemic, but with the pandemic having come to a close, it may be time to examine the FDA’s standing guidance for AM.
If a traceability analysis isn't performed correctly or at the right time or frequency, gaps may go unnoticed that could negatively impact patient safety, device effectiveness, overall patient experience, regulatory submissions, and even result in a recall once the device is commercialized.
Predetermined change control plans (PCCPs) may be the way of the future for 510(k) medical device software, but the vast majority of both hardware and software device products still do not incorporate a PCCP. As a consequence, the FDA’s existing policies for when to file a new 510(k) are still in effect, and this blog will provide a closer look at the related guidances.
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.
The FDA’s draft guidance for predetermined change control plans (PCCPs) is months away from conversion into a final guidance, but that hasn’t stopped software developers from creating products with a PCCP component for the U.S. market. The FDA approved the de novo application by Caption Health on Feb. 24, 2023, for a machine learning (ML) product that processes ultrasound images to calculate left ventricular ejection fraction (LVEF).
This new paper on AI and machine learning (ML) in drug development includes the use of any software that is regulated as a medical device for the drug development process. Indications are that such a software development project may require deep pockets.
Michelle will review submissions for Enzyme clients and consult with them on regulatory strategy as well as provide valuable input on Enzyme’s product roadmap. She has authored and led numerous premarket submissions and regulatory strategies for Class I-III devices.
An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market.
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
