The request is part of President Trump’s budget and has taken on new urgency with the spread of the coronavirus worldwide.
The FDA does not have the same authorities for medical device shortages as it does for drugs and biological products, according to Hahn. Medtech manufacturers are under no legal obligation to notify the FDA of a potential shortage or to respond to agency requests about potential supply-chain disruption, he added.
“Enabling the FDA to have timely and accurate information about likely or confirmed national shortages of essential devices would allow the agency to take steps to promote the continued availability of devices of public health importance,” Hahn said in a statement.
The agency proposes:
- All medtech companies notify the it of an “anticipated meaningful interruption in the supply of an essential device.” The FDA defines essential devices as those that may be prone to potential shortage if there is a supply disruption.
- Requiring all essential device manufacturers to periodically update the FDA about the manufacturing capacity for the essential devices they produce.
- Authorizing the temporary importation of devices that it would otherwise exclude when the benefits of the device in mitigating a shortage outweigh the risks.
“Overall, this remains an evolving and very dynamic issue,” Hahn said.
Several of the 72 medtech factories in China that supply the U.S. market have been affected by the coronavirus, but no shortages have emerged for these types of devices, according to the FDA chief. The agency has been in touch with the 63 companies that own the factories, some of whose workers are under quarantine, and it continues to assess the situation, Hahn said.
Medtech trade group AdvaMed commended the Trump administration for its efforts to ensure the integrity of the U.S. medical supply chain, but advised caution before promulgating any new regulations.
“The medical technology industry has a long history of working with FDA and other federal agencies during national disasters, pandemics, and other public health emergencies to ensure the continued availability of the medical technologies patients need most,” AdvaMed president & CEO Scott Whitaker said in a statement to MassDevice. “That collaborative approach continues now as we all work together to address the coronavirus crisis. Mandatory reporting requirements impact every health care sector differently, which means the question is really about getting the policy right. We need to be sure any requirement actually helps public health officials and isn’t counterproductive — particularly during this time of crisis. We look forward to working with the administration on this, as well as with our partners in the coronavirus task force.”
The FDA said orders for personal protective equipment such as surgical gowns, gloves, masks, respirator protective devices are on the rise in the U.S. as some healthcare facilities prepare for potential needs if the outbreak becomes severe, he added, but no widespread shortages have been reported.
“As with prior emergencies, the FDA has taken proactive steps to establish and remain in contact with medical device manufacturers and others in the supply chain, including hospitals and group-purchasing organizations,” Hahn said. “The agency also encourages manufacturers and healthcare facilities to report any supply disruptions to the device shortages mailbox, deviceshortages@fda.hhs.gov. This mailbox is closely monitored and has proven to be a valuable surveillance resource to augment FDA efforts to detect and mitigate potential supply chain disruption.”
This article has been updated with comments from AdvaMed.
