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 One of these—the draft guidance for 510(k) clinical data—brings several critical questions into focus, such as the circumstances in which a change in the indication for use may require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A new draft guidance from the FDA offers insight into the process by which a manufacturer might select a predicate device for a new class II product under the 510(k) program.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.
During the COVID-19 public health emergency (PHE), FDA's enforcement discretion policies allowed Americans to have access to numerous medical devices that would traditionally undergo FDA review and clearance/approval without this review. Although this was good for the American public, there was always an outstanding question of what would happen once the PHE ended: How would FDA approach these medical devices and regulate them again? Here's the details of the FDA's transition plan for medical devices as these enforced discretion policies come to an end.
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.
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.
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.
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