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

Hazards of Indication for Use Highlighted in FDA Draft Guidance

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 One of these—the draft guidance for 510(k) clinical data—brings several critical questions into focus, such as the circumstances in which a change in the indication for use may require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.

New FDA Draft Guidance Provides More Clarity Regarding Predicate Devices

A new draft guidance from the FDA offers insight into the process by which a manufacturer might select a predicate device for a new class II product under the 510(k) program.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.

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.

The Hazards of FDA’s When-to-File Policies for 510(k)s

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.

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.