Source : Medtech Insight
The US Food and Drug Administration on 3 August announced a new online webform to make it easier for makers of medical devices deemed critical to fighting the ongoing COVID-19 pandemic to report product shortages.
The webform is “intended to further assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical devices,” the agency says.
The FDA debuted its product shortage list in August 2020. The online list was mandated by Sec. 506J of the Federal Food, Drug and Cosmetic (FD&C) Act, which gave the agency new powers to help prevent or mitigate device shortages before or during a public health emergency. ("Experts Ho-Hum About FDAs First-Ever Device Shortage List" "Medtech Insight" )
Sec. 506J was added to the FD&C Act by way of the CARES Act, a massive stimulus bill signed into law by former President Donald Trump in early 2020.
Under Sec. 506J, makers of particular devices must inform the FDA of “an interruption in the manufacture of [a] device that is likely to lead to a meaningful disruption in supply of that device” in the US during a declared public health emergency.
The FDA’s new webform gives reporting manufacturers the ability to:
Submit notifications directly into the webform;
Submit larger numbers of notifications using a spreadsheet template; and
Voluntarily notify the FDA that the company isn’t experiencing an interruption or discontinuance.
Device makers can update information in their submissions when necessary, the agency says.
In a November 2020 guidance document, the FDA said companies that fail to notify the agency of shortages could be issued a letter of noncompliance. ("FDA Will Fire Off Noncompliance Letters To Firms That Dont Report Device Shortages Agency Warns" "Medtech Insight" )
By Shawn M. Schmitt