The Senate Health, Education, Labor and Pensions (HELP) Committee has posted its version of U.S. FDA user fee legislation, a bill that echoes many of the primary features of the version already at play in the House of Representatives. One critical difference is that the Senate bill includes legislation that would enable the FDA to regulate lab-developed tests (LDTs), the so-called Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the omission of which from the House bill ruffled a few feathers. The American Clinical Laboratory Association (ACLA) responded to the Senate bill with a May 17 statement applauding the inclusion of the VALID Act in the Senate user fee bill.
The European Commission (EC) has proposed new legislation directed toward formation of a European Health Data Space (EHDS), which is nominally intended to address some perceived gaps in the General Data Protection Regulation (GDPR). While this legislative proposal seems to interact with both the GDPR and pending EU legislation on artificial intelligence, the EHDS takes on the massive challenge of compulsory interoperability of electronic health records (EHRs). The EC unveiled the proposal with an emphasis on health data accessibility, although both the European Council and the European Parliament will now have their say over how the legislation will ultimately read.
Regulatory harmonization is seen as vital to the development of markets for artificial intelligence (AI) and machine learning (ML), but there is some variation in the terminology used to describe these algorithms. The International Medical Device Regulators Forum (IMDRF) has posted a document that includes some definitions for ML terms such as unsupervised machine learning, a key development if regulations across the globe are to avoid a hopeless state of balkanization.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
The U.S. FDA posted a final guidance for feasibility and early feasibility studies for non-traditional devices for type 2 diabetes, a document that is largely unchanged from the draft. This in the eyes of some stakeholders is precisely the problem as the final guidance retains a set point for rescue medication that some in industry believe is inappropriate for a study that does not seek to establish device effectiveness.
Intersect ENT Inc., of Menlo Park, Calif., picked up Fiagon AG Medical Technologies less than two years ago in a bid to expand its footprint in the ear/nose/throat (ENT) business, but that acquisition is about to be undone. The U.S. Federal Trade Commission (FTC) said Intersect will have to jettison Fiagon because of Dublin-based Medtronic plc’s acquisition of Intersect, thus unwinding a transaction that was valued at €60 million (US$62.4 million) in September 2020.
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House.
The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.
The Medical Device Innovation Consortium (MDIC) ran a series of 14 test cases to evaluate the value of real-world evidence (RWE) for regulatory decision making, but there were several sources of drag in this first phase of the project, such as a lack of availability of unique device identifiers (UDIs) for some devices.
Cybersecurity remains a pressing issue for medical technology, in part because there are new, small companies jumping into this space seemingly every day. However, there is a shortage of talent in cybersecurity, something that Dan Lyon, director of cybersecurity at Boston Scientific Corp., of Marlborough, Mass., said will not ease soon due to a lack of interest among colleges and universities in providing curriculum and degrees in this area.
