The U.S. FDA has posted yet another two regulations for devices granted market access via the de novo petition program, one of which addresses dry eye by means of pulsatile light emissions. This device may serve as a predicate for many 510(k) devices if estimates of prevalence in the tens of millions in the U.S. are any indication.
Bringing notified bodies (NBs) into a med-tech regulatory system has proven to be no mean feat in the European Union, but the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) seems not to suffer from such impediments. The agency just added several in vitro diagnostic (IVD) technological areas to the roster of tests that can be reviewed by UL International UK, an addition that will help ensure patients can obtain the tests they need.
The fifth medical device user fee agreement (MDUFA V) is a generous bump in monies for the U.S. FDA, some of which will go toward advancing the use of real-world evidence (RWE) in the agency’s regulatory decisions. The FDA just opened a docket for comment on how those monies might be doled out to entities other than the Medical Device Innovation Consortium (MDIC), an expansion that might nudge the regulatory science along a little more quickly and thus enhance the use of RWE for premarket submissions.
The new year always brings with it a series of New Year’s resolutions, and the U.S. FDA has apparently resolved to catch up on its backlog of de novo notifications. The earlier of the two de novo regulatory announcements is for a digital product by Minneapolis-based Nightware Inc., and its namesake kit for reduction of sleep disturbances, a regulation that arrives more than two years after the product was granted market access.
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) each allow a hospital to develop a device or an in vitro diagnostic for use solely in that hospital, but there is no regulatory free pass despite the lack of commercial intent. While the latest guidance on these in-house tests acknowledges that the hospital must determine the degree to which it must comply with the relevant regulation, any hospital that makes and uses an in-house diagnostic or device must develop a risk management mechanism for that device or diagnostic, not an easy lift for entities that may be glancingly familiar at best with conventional regulatory schemes.
At a time when Chat GPT is making waves in the world of artificial intelligence (AI), new legislation is making the rounds in Washington that would allow an AI algorithm to write prescriptions for pharmaceuticals. Rep. David Schweikert (R-Ariz.) introduced H.R. 206 to the House Energy and Commerce (E&C) Committee Jan. 9, although at present the bill enjoys the backing of no other members of the House, suggesting that this legislation has a steep climb in front of it.
The U.S. FDA and Health Canada announced that they will roll out a pilot program that allows a medical device manufacturer to submit a medical device application to both agencies simultaneously for class II and class III medical devices.
The U.S. FDA’s 510(k) program is yet again under assault, this time from the authors of a Jan. 10 article in the Journal of the American Medical Association (JAMA). The authors’ primary point seems to be that any 510(k) devices that recite a predicate that is the subject of at least three recalls are themselves more likely than average to be the subject of a recall, although there was no discernible association between recall status and technological differences between the predicate and the follow-on devices.
The U.S. FDA’s surveillance of endoscopes related to reprocessing issues has yielded two more warning letters, one each for Tokyo-based Olympus Medical and its Aizu Olympus subsidiary, both of which were cited for inadequate procedures for medical device reports (MDRs).
Sotera Health Services LLC, the parent company of Sterigenics US LLC, has agreed to pay $408 million to settle more than 870 lawsuits pending against the company in Illinois as a means of moving past the specter of ongoing litigation over Sterigenics’ use of ethylene oxide (EtO) for contract medical device sterilization. The settlement may open the doors to litigation over other sterilization plants’ use of the sterilant, constituting an industry-wide attack on device sterilization services that may crimp supplies of devices that are not candidates for other methods of sterilization.
