The FDA’s draft guidance for predetermined change control plans (PCCPs) is just that, a draft guidance, but that has not stopped the agency from incorporating the underlying concepts into existing guidances. An example of this is the September 2023 guidance for antimicrobial susceptibility test (AST) system for breakpoints in device labeling, a document that represents a jarring update to the legacy version published in 2009.
The U.S. FDA has finally let fly with a draft rule for regulation of lab-developed tests (LDTs), an 83-page document that delves into the legal controversies regarding whether the agency has the requisite statutory authority. However, Allyson Mullen, a director in the D.C. office of Hyman, Phelps & McNamara P.C., told BioWorld that the emergence of this draft rule doesn’t mean Congress won’t eventually be dragged back into the LDT fray, particularly if stakeholders litigate to overturn the draft.
The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome.
Patent challenges for radiotherapy equipment might not make the splash that in vitro diagnostic patents have, but Elekta AB and Zap Surgical Inc., have been locked in a dispute over an Elekta patent for the past four years.
The Consolidated Appropriations Act of 2023 covered a lot of budget terrain for the U.S. federal government, but Section 3305 was unusual for this type of bill in that it called on the FDA to require cybersecurity features as a part of the Quality System Regulation (QSR).
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is one of a number of efforts on the agency’s part to reduce the drag on premarket medical device submissions, but the agency has now converted the ASCA pilot into a full-blown regulatory program. Fortunately for both the FDA and industry, most of the guidance groundwork is already in place, making the ASCA program a ready-to-go method for streamlining at least one element of premarket applications for medical devices.
Developers of combination products face an unusual dilemma in their interactions with the U.S. FDA, given that the data for the constituent products reside in multiple product centers. Some of the related clunkiness may soon be a thing of the past thanks to a new four-year proposal to overhaul the FDA’s information technology infrastructure, which among other things will emphasize a more seamless sharing of data across centers, precisely the kind of initiative that would facilitate reviews of combination products.
The U.S. FDA has broken out of the summer guidance doldrums in fine form, inking a series of nine draft and final guidances in the first half of September alone. The latest bolus includes a revised version of a guidance for the breakthrough devices program and two draft guidances for devices for weight loss, giving industry plenty to mull over as the final days of fiscal year 2023 trickle away.
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
The U.S. FDA is keen on developing policies to guide testing regimes for future pandemics based on the experience with COVID-19, and the FDA’s Tim Stenzel said on a Sept. 8 advisory hearing that automated reporting of at-home tests would clarify questions such as the spread of the pathogen and how well the tests are performing. Stenzel, who is the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said the U.S. government agencies have made a number of grants for development of automated reporting mechanisms for at-home tests, signaling an interest on the FDA’s part that automated reporting capabilities will be a priority when the next pandemic strikes.
