On November 15, HHS announced that it was withdrawing the prior administration’s policy that prevented FDA from requiring premarket review of laboratory developed tests (LDTs) without notice and comment rule making. See the prior post on this policy here. This statement comes at least six …
Sixteen years after the publication of the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005, FDA issued a new draft guidance document on November 4, 2021 that describes the recommended documentation that a sponsor should include …
In England, over‑the‑counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. In America, these tests are scarce and relatively high‑priced. Why is that? Background Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence …
FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. An eCopy is an electronic copy of the 510(k) that is comprised …
After 23 years, de novo classification review finally has an implementing regulation! The other major review processes have had their regulations in place for many decades. The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only …
In recent years, for novel robot assisted surgery (RAS) devices, FDA’s Center for Devices and Radiological Health (CDRH) has taken the approach of clearing RAS devices for specific indications for use. Gone are the days of tool type indications for this type of device. Rather, …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15. This conference will analyze the latest regulatory issues related …
On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. We have previously posted blogs about FDA’s increasing interest on cybersecurity both in the premarket (see our past blog posts here, here, and here) and the postmarket …
Companies often use rebranding to reposition and refocus their business. Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally. The federal government does its own version of rebranding with each change in administration. Just before the July 4 holiday weekend, …
A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. It is embodied in parallel drug and …
On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. and the Court of Appeals for the D.C. Circuit, FDA published a Federal Register Notice today (August 9) soliciting comments …
For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). Distributed IVD products are regulated by FDA, while laboratories that perform LDTs are regulated by the Centers for …
In the first challenge ever brought against FDA’s rarely used power to ban a medical device, a court found FDA overstepped its authority and overturned the ban. In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to …
On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices, which has been several years in the making. The draft guidance distinguishes between “remanufacturing” and “servicing” of devices. This distinction can be critical, due to the significantly increased regulatory requirements that …
In our last post on Laboratory Developed Tests (LDTs), we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. Coincidentally, on the same …
