Avita Medical Ltd.’s Recell system won FDA breakthrough device designations in soft tissue repair and vitiligo. Melbourne-headquartered Avita, a regenerative medicine company developed the Recell system, a technology platform that enables point-of-care autologous skin restoration.

The U.S. FDA held a two-day advisory hearing in the last week of October 2022 to address some lingering regulatory questions, including the question of whether therapeutic nail prostheses should be a class I device. The potentially more dramatic shift, however, would be the application of a class III risk designation to tissue expanders used in breast surgery.

Shortages of medical devices were not particularly topical before the COVID-19 pandemic, but they have dotted the landscape in the past three years despite the U.S. FDA’s best efforts to manage such issues. The agency recently announced that tracheostomy tubes are now among the device types that are in a state of shortage, a problem created by a paucity of the raw materials used to manufacture these items.

The U.S. CMS has peeled back a proposed 4.2% rate cut in the home health payment draft rule for calendar year 2023, replacing it instead with a 0.7% increase in overall payments for home health services, a category that affects sales of durable medical equipment and home infusion therapy items. That change was insufficient to mollify the National Association for Home Care & Hospice (NAHC), which argued that the final rule will nonetheless severely hit home care providers and leaves NAHC with no choice but to take its concerns to Capitol Hill.

A U.S. FDA advisory panel saw a number of problems in the clinical trial for the Avertd test for opioid use disorder (OUD), including the fact that the study failed to enroll a sufficiently ethnically diverse body of subjects. Perhaps more damning was that the advisory panel was uncertain as to whether the 15 single nucleotide polymorphisms (SNPs) evaluated in the test were helpful in sorting out which patients were truly at high risk of OUD, leading to an 11-2 vote that the probable benefits of the test do not outweigh the risks.

Innovative medical devices are the norm for reviewers at the U.S. FDA’s Center for Devices and Radiological Health (CDRH), but regulatory innovation is a tougher climb. In response, CDRH director Jeff Shuren said at this year’s Medtech Conference in Boston that the agency is eyeing a voluntary alternative pathway (VAP) for novel digital technologies, although this concept is unlikely to see the regulatory light of day other than as a pilot program at any point in the next year or two, given the need for statutory authorization.