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.
The U.S. Centers for Medicare & Medicaid Services (CMS) is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
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.
Apple Inc., of Cupertino, Calif., has prevailed over Masimo Corp., in a ruling at the U.S. Court of Appeals for the Federal Circuit, an outcome that invalidated several Masimo patents for physiological monitoring. However, the two companies are not finished with each other yet as the International Trade Commission has yet to rule on a similar case that could foreclose importation of Apple devices on grounds of patent infringement.
Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.
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.
China’s National Medical Products Administration (NMPA) has largely completed its development of overarching regulations for medical devices and is now drilling down into more granular matter, such as a guidance on assessments of benefits and risks for medical devices. Grace Fu Palma, CEO of China Med Device LLC, told BioWorld that this new guidance is a much more detailed version of the 2019 edition, but added that China’s anticorruption efforts will be ramped up with an eye toward health care, just one of several current and impending developments of interest in this massive market.
The question of third-party litigation funding has been front and center for life science companies in recent years, with one of the key considerations a lack of transparency as to the source of the funding behind much of this litigation. That lack of transparency was front and center in the Sept. 13 hearing in the U.S. House of Representatives, but the tenor of the hearing made clear that some members of Congress will stand in opposition to any reforms even though the lack of transparency is widely seen as enabling meritless litigation.
The Medical Imaging & Technology Alliance (MITA) has filed its comments for two draft Medicare rules, citing ongoing concerns over how Medicare pays for a variety of aspects of medical imaging procedures.
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).
