The U.S. FDA’s guidance for electromagnetic compatibility (EMC) in medical devices has several moving parts, a consequence of the fact that the scope included cardiac electrophysiology devices and non-implantable medical devices. For the most part, the terms of the guidance will go into force within 60 days, but the compliance deadline for in vitro diagnostics (IVDs) doesn’t go into force until June 6, 2023, giving these manufacturers much more breathing room than their non-IVD counterparts.
The U.S. FDA determined that the pandemic required an adjustment to applicant turn-around times for the agency’s responses to regulatory filings, an allowance that was unavoidable given the impact of the pandemic on applicants’ ability to respond. That policy has now been reversed, the agency said, which means that a failure to respond to queries about 510(k) filings within 180 days will lead to an assumption on the agency’s part that the applicant has withdrawn the submission.
The U.S. FDA has received a citizen’s petition regarding the use of neuropsychological testing prior to placement of a deep brain stimulation (DBS) device for treatment of Parkinson’s disease. The petitioners, most of whose names were redacted, said that there is no standardized test for this purpose, and thus the patient should have sole discretion of evaluating the meaning of their own tests or the use of these tests should not be seen dispositive of the question of whether to go ahead with placement of a DBS device for Parkinson’s.
U.K.’s Angle plc has become the first company to receive a U.S. FDA product clearance for harvesting intact cancer cells for analysis. Angle reported it scored FDA clearance for its Parsortix system for the capture and harvest of circulating tumor cells (CTCs) from metastatic breast cancer patient blood. Shares in the AIM-listed company soared by more than 50% following the news.
Ethylene oxide (EtO) has been a mainstay in medical device sterilization for decades, but fears of carcinogenicity sparked protests outside EtO sterilization plants in Georgia and Illinois in 2018. While the COVID-19 pandemic overrode those concerns for two years, the FDA has opened a pilot program for conversion of sterilization methods that would require fewer regulatory filings than would otherwise be the case.
Device makers do not engage in direct-to-consumer advertisement at the same pace as drug makers, but advertising and promotions are still a minefield of potential enforcement action for the unwary manufacturer. According to Jesse Atkins and Nate Downing of Gardner Law in Stillwater, Minn., even a minor skirmish with the FDA can result in an extensive review of standard operating procedures, a potentially expensive and time-consuming distraction from companies fighting for market share in the hotly contested U.S. market.
The U.S. FDA has granted de novo approval for Bonesupport AB’s Cerament G, an antibiotic-eluting bone graft designed to osteomyelitis. The company plans to launch in the U.S. in late September or early October.
In the last week, the U.S. FDA has taken two steps to expand treatment options for the millions of patients with fibromyalgia who find little relief from the three approved drugs for the condition. Neurometrix Inc. reported that the agency granted de novo authorization to its Quell device Thursday and Remedee Labs SA announced it received breakthrough device designation for its endorphin stimulation system May 12.
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
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.
