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

The Implications and Timing of the FDA Draft Rule for LDT Regulation

The FDA draft rule for regulation of lab-developed tests (LDTs) is no radical departure from the Agency’s traditional regulatory scheme, but it would force clinical labs to conduct a major overhaul of their regulatory operations. There is still a debate as to whether the Agency is fully legally authorized to regulate LDTs, but there are other considerations which suggest the FDA’s timeline for this draft rule is highly ambitious.

Hazards of Indication for Use Highlighted in FDA Draft Guidance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 One of these—the draft guidance for 510(k) clinical data—brings several critical questions into focus, such as the circumstances in which a change in the indication for use may require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New FDA Draft Guidance Provides More Clarity Regarding Predicate Devices

A new draft guidance from the FDA offers insight into the process by which a manufacturer might select a predicate device for a new class II product under the 510(k) program.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

FDA Guidance Provides Road Map for Use of Real-World Data and Evidence

The new FDA guidance on the use of real-world data (RWD) and real-world evidence (RWE) is a long-anticipated playbook for how a drug manufacturer can employ a non-interventional study for regulatory decision-making. The process is not as simple as extracting observational data from a registry, although the benefits are potentially immense given that the sponsor can avoid the need for an expensive and cumbersome randomized controlled clinical trial (RCT).

How to Navigate the End of FDA’s Enforcement Discretion Policies

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.

Key Takeaways from New FDA Guidance on Off-the-Shelf Software

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.

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.

Guidance for Additive Manufacturing Post-Pandemic

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.

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.