The FDA’s three September draft guidances for the 510(k) program provide much-needed clarity regarding premarket notifications under the 510(k) program and are part of a set of reforms the Agency proposed in 2018. One of these—the draft guidance for 510(k) clinical data—brings several critical questions into focus, such as the circumstances in which a change in the indication for use may require clinical testing.
A new draft guidance from the FDA offers insight into the process by which a manufacturer might select a predicate device for a new class II product under the 510(k) program. While this document does not necessarily constitute a new approach to the selection of a predicate device, it does make clear that the FDA strongly prefers that a predicate have a clean record for adverse events (AEs) and device malfunctions.
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The FDA’s draft guidance for predetermined change control plans (PCCPs) is months away from conversion into a final guidance, but that hasn’t stopped software developers from creating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).
One of the essential elements of this guidance is that the end-of-life/end-of-service (EOL/EOS) declaration for a software or firmware component can precipitate the same state for the medical device manufacturer’s (MDM’s) product, a problem that must be dealt with in advance to ensure that the MDM is not forced to prematurely withdraw its medical device.
While SBOMs may not fundamentally change your perspective on cybersecurity, they can be tremendously useful not just in managing cybersecurity across the total product life cycle (TPLC), but also in sustaining good relationships with customers and regulatory agencies.
Clinical trial monitoring for FDA-regulated products can be expensive and troublesome, but digital health technologies (DHTs) can make the process less painful and more cost-efficient. However, in order for clinical trial sponsors to enjoy these benefits, proper planning and execution will be necessary, according to a new FDA guidance for clinical trial monitoring.
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.
The FDA has released a draft guidance for an alternative to its traditional medical device reporting (MDR) program — the voluntary malfunction summary reporting (VMSR) program — which eases the burden of post-market surveillance for a large number of device types.
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