Over the years, we have blogged many times on FDA’s approach towards laboratory-developed tests (LDTs) (see, e.g., prior posts here, here, here, here, and here). On October 31, 2018, FDA issued a Safety Communication relating to one particular type of LDT: pharmacogenomic (PGx) assays. On …
The distinction between a drug and a device is a critical one: drugs and devices are subject to different regulatory schemes, with the drug pathway being significantly more onerous and expensive. User fees alone for a generic drug total $300,000 for the first year compared …
On November 5, 2019, the U.S. District Court for the Northern District of California ruled in favor of Theranos founder Elizabeth Holmes and former Theranos president Sunny Balwani, in a battle over access to government documents. While this represents a small victory for these defendants, …
FDA is issuing final guidance on how device firms may request review of a decision to withhold issuance of a Certificate to Foreign Government (CFG). What is a CFG? In many cases, foreign governments will seek official assurance that products exported to their countries are …
Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …
A warning letter issued earlier this year by the Food and Drug Administration (FDA) to Inova Genomics (Inova) prompts some reflections on where things stand now with the regulation of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FDCA). An LDT, …
Nearly three years after Section 3060(a) of the 21st Century Cures Act amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by removing certain software functions from the device definition in section 201(h) of the FD&C Act, FDA has released Changes to …
On September 27, 2019 FDA issued several updates to advance their digital health policies. One of these updates was a new draft guidance, Clinical Decision Support Software (“Guidance”). This draft guidance replaces the 2017 draft guidance, Clinical and Patient Decision Support Software (“Prior Draft”), which …
FDA formally announced the Safer Technologies Program (STeP) in a December 2018 press release from then-FDA Commissioner Scott Gottlieb, M.D., and Director of CDRH Jeff Shuren, M.D. Details on the program were limited other than to say that the program would be designed to complement …
There is little or no debate that patients are the experts on their own diseases. The FDA has promoted this concept for years and on September 24, 2019, the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) …
On September 13, 2019 FDA issued a final guidance document The Special 510(k) Program (“Guidance”). We blogged about the prior draft guidance here. This Guidance, along with The Abbreviated 510(k) Program, supersedes the 1998 guidance document The New 510(k) Paradigm – Alternate Approaches to Demonstrating …
On September 9, 2019, FDA issued a final guidance, Acceptance Review for De Novo Classification Requests. The guidance is meant to provide clarity on the Agency’s expectations for information to be submitted in a De Novo request and to ensure predictability and consistency for sponsors. …
Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. The recent Supreme Court ruling in Kisor …
Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …
FDA recently finalized the guidance document, Postmarketing Safety Reporting for Combination Products (“PMSR Guidance”). The PMSR Guidance addresses compliance with the final rule on postmarketing safety reporting (PMSR) requirements, 21 C.F.R. Part 4, Subpart B (“PMSR final rule”), for combination products. This is a complicated …
