President Joseph Biden signed into law the CHIPS and Science Act of 2022, a bill that calls for investment of $280 billion overall into the development and manufacturing of semiconductor products and which should ease the crunch on these products for medical device manufacturers. However, some have estimated that bringing new production capacity online can take three to five years, suggesting that the med-tech industry will need to continue to devise workarounds to the current supply crunch for the immediate future.
The controversies over the use of ethylene oxide (EtO) as a medical device sterilant were quelled by the COVID-19 pandemic, but the U.S. Environmental Protection Agency (EPA) has resurrected the issue.
The shortage of semiconductor products has plagued the U.S. medical device industry for better than a year, but there is legislation in play in Washington that might bring some relief. The White House held a July 25 briefing during which President Joseph Biden promised his support for the CHIPS Plus Act of 2022, a development that could break a legislative logjam.
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network.
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 shortage of semiconductor products, such as computer processors, was an artifact of the COVID-19 pandemic, but the shortage has yet to ease, to the detriment of hospitals, device makers and patients. That dilemma surfaced again as the U.S. Department of Commerce met with device makers to discuss the dilemma, which in the views of some still constitutes a crisis of health care.
The U.S. FDA has been scrutinizing surgical meshes for safety considerations for longer than a decade, but litigation continues to dot the legal landscape. An appeals court in the state of California decreed recently that Johnson & Johnson of Franklin Lakes, N.J. must pay more than $300 million over allegations that its Ethicon subsidiary had downplayed to patients the risks associated with its pelvic meshes, but J&J said its next step is to appeal the outcome in the state’s highest court.
The U.S. FDA’s draft device user fee agreement was months late in arriving on Capitol Hill, a fact which also delayed the public meeting on the draft, an event that finally took place April 19. The meeting kicked off with an acknowledgement by second-time FDA commissioner Robert Califf of the growing role of user fees in FDA finances, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said that the quality of FDA reviews was at least as important as the timeliness of those reviews even though the user fee deals include many deadline-based metrics.
The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.
