The U.S. FDA’s regulation of commercial speech under the First Amendment has been controversial and has handed the agency several losses in court, but Arun Rao of the U.S. Department of Justice (DOJ) let it be known that DOJ is still keen on commercial speech enforcement. Rao said the case of Gonzalez v. Google, which will be heard by the Supreme Court, is an example of potentially precedent-setting litigation, and that manufacturers of drugs and devices may experience an uptick in enforcement depending on where the Supreme Court lands in Gonzalez.
The U.S. FDA’s agreement with industry for the fifth device user fee agreement (MDUFA V) included a pilot for the total product life cycle advisory program, or TAP, which is designed to ensure that potential device problems are addressed before production of the finished device design. However, the agency acknowledged that the TAP program will require significant numbers of new hires, which promises to be a significant hurdle given that the agency struggled to meet its hiring goals under the previous device user fee agreement.
Applied Tissue Technologies LLC (ATT) has won U.S. FDA clearance for a negative pressure wound therapy (NPWT) system that eliminates foam as a potential impediment to complete wound healing. ATT CEO Michael Broomhead said negative pressure wound therapy is ripe for a true innovation to kick its Platform Wound Dressing (PWD) and the treatment “into its next generation.”
The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly, an example of which is the increase for new drug applications (NDAs) requiring clinical data from $3.12 million to $3.24 million. Fees for medical device premarket approval (PMA) filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation, a problem that may plague the user fee schedules for fiscal 2024 as well.
The U.S. FDA’s device center recently advised companies that make tests for the COVID-19 pandemic that the emergency use authorization program for tests is winding down, albeit with a few exceptions.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
The U.S. FBI is not typically seen as playing a meaningful role in medical device cybersecurity, but the agency recently released a report regarding unpatched and outdated medical devices, nonetheless. The report includes five recommendations to deal with these devices, but the agency gives no indication as to whether the report signals an interest in enforcement activities related to medical device cybersecurity.
Millions of patients with fibromyalgia have battled widespread pain with few effective treatment options for decades. The U.S. FDA has offered reason for hope and better health with four recent decisions. On Oct. 4, Solon, Ohio-based Multi Radiance Medical Inc. (MRM) received clearance for its Fibrolux therapy laser for the condition, following Neurometrix Inc.’s de novo authorization for its transcutaneous electrical nerve stimulation device, Quell, in May. Remedee Labs SA received breakthrough device designation (BDD) for its endorphin stimulation system in May and Swing Therapeutics Inc. was granted BDD for its digital therapy in Aug. 2021.
The U.S. FDA’s finalized guidance for clinical decision support (CDS) software was not an entirely isolated policy change inasmuch as there were several other guidances that were edited and reissued two days after the CDS final was published. One of these is the guidance for device software functions and mobile medical apps, which now encodes a transparency requirement as seen in the CDS guidance, a change that may represent a hazard for the unwary medical software developer.
The U.S. Congress has finally managed to pass legislation that reauthorizes several FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year.
