FDA issues policy for manufacturers to prevent medical device shortages
The Food and Drug Administration today issued guidance implementing section 3121 of the Coronavirus Aid, Relief, and Economic Security Act, which requires manufacturers to notify FDA of a permanent discontinuance or significant interruption in the manufacture of certain medical devices to prevent or mitigate shortages during the COVID-19 emergency.
FDA said the guidance aims to clarify and make recommendations regarding who must notify FDA and how, and what information to include in the notification.
Related News Articles
Headline
The Centers for Disease Control and Prevention is predicting a similar combined number of peak hospitalizations from COVID-19, the flu and respiratory…
Headline
The Occupational Safety and Health Administration today announced a 60-day extension of the comment period on its proposed rule to remove the remaining…
Headline
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…
Headline
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…
Headline
The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one underlying condition that…
Headline
The Occupational Safety and Health Administration June 30 released a proposed rule to remove what remains of its emergency temporary standard for occupational…