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On May 14, 2024, FDA hosted a webinar to provide an overview of its final rule “Medical Devices; Laboratory Developed Tests” as well as FDA’s phaseout of its general enforcement discretion approach to laboratory developed tests (LDTs).   

The October 2023 proposed rule sought to phase out enforcement discretion for LDTs more broadly. However, FDA seems to have considered some of the concerns commenters raised about access to LDTs and the cost of compliance. The final rule retains varying degrees of enforcement discretion for specific types of LDTs.Continue Reading FDA LDT Rule Begins Enforcement Discretion Phaseout, But Some Discretion Remains

[Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (referred to hereafter as 2023 CAA). Part 1, available here, covered changes in Medicare payment rates.]

Buried in the “Miscellaneous” chapter of Subtitle F (“Cross-Cutting Provisions”) of the Food and Drug Administration Title (Title III) of the 2023 CAA is Section 3630, a provision without a short title called “Facilitating exchange of product information prior to approval.”

This provision was originally proposed as the Pre-approval Information Exchange Act (or PIE Act) in March 2022 and was included in the House version of the Food and Drug Administration user fee legislation before being dropped from that legislation along with almost all other policy riders in a deal to get the FDA User Fee program approved before it expired.

But the same language was included in the 2023 CAA that was signed into law on Dec. 29, 2022. And again, while it was not directly entitled as such in the law, it is the PIE Act and that is how this post will refer to it. So, exactly what is the PIE Act and what does it do?  Before assuming there is “PIE” for everyone, read more for important content on the boundaries of this law, and remaining challenges for companies seeking to exchange information under this statutory authority.Continue Reading Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act

On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act.

The final rule, which takes effect January 3, 2022, comes nearly three years after the FDA first proposed it and, notably, sets forth the procedures and criteria for a manufacturer’s voluntary submission and withdrawal of a De Novo request.  Additionally, the rule clarifies how agency staff intends to accept and review the requests, as well as how FDA staff will determine whether to grant or decline the requests.  Finally, the rule also provides a way for combination products to use the De Novo pathway.

Useful for novel, low risk medical devices

The implementation of the De Novo classification process is especially significant for manufacturers of novel, low-risk medical devices.  Prior to the De Novo program, which was created in 1997, any device that lacked a predicate automatically became designated as a Class III device and, therefore, required premarket approval to legally reach the market.  Because this premarket pathway is designed to regulate the riskiest category of devices, manufacturers typically had to endure longer than anticipated wait times for approval of their low-risk devices.Continue Reading FDA codifies requirements for the medical device De Novo classification process

This post was written by Jillian W. Riley.

Earlier this week, FDA’s Center for Devices and Radiological Health (CDRH) published two separate draft guidance documents to advance the dual goals of FDA and industry to provide pathways for medical devices to reach the market quickly while ensuring the safety and efficacy of the product.

The…

This post was written by Erin Janssen.

FDA has announced the release of a draft guidance document concerning the necessary elements and contents of a complete premarket approval (PMA) application and the key decisions that are made during the filing process. The draft guidance applies to all devices reviewed in a PMA application and,…

On October 7, 2011, the Centers for Medicare & Medicaid Services and the Food and Drug Administration announced they are soliciting nominations from sponsors of medical devices to participate in a parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the “Notice”), with an effective date…