Face Masks | 合法醫療器材資訊網

2021年4月9日—Facemasksmarketedtothegeneralpublicforgeneralnon-medicalpurposes,suchasforuseinconstructionandotherindustrialapplications, ...

The FDA encourages health care facilities which anticipate a potential shortage or are experiencing an actual shortage to notify the FDA. For potential or actual supply issues, e-mail information to the FDA at [email protected][1].

For manufacturers:

Certain device manufacturers are now required under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to notify the FDA of an interruption or permanent discontinuance in manufacturing. Section 506J of the FD&C Act[2] requires manufacturers to notify the FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States.

The FDA has issued a guidance[3] to assist manufacturers in providing the FDA with timely and informative notificat...