New devices added to the device discontinuance list.
The FDA is constantly reviewing their emergency use list. As we have been writing and warning that as the amount of needed products come to market via the EUA and 510(k) the FDA will discontinue the items.
Companies should be away that they will need to have their 510(k)s cleared to continue to market the devices once the EUAs are lifted.
On January 22, 2021 the FDA added two new devices to the device discontinuance list. The FDA releases this list to provide transparency to the public as well as fulfilling a statutory obligation within section 506J of the FD&C Act. There have been no new additions to the device shortage list at this time. As the COVID-19 crisis evolves the lists will be updated.
The two new additions to the device discontinuance list are as follows:
- 3M company’s 3M Triple layer Molded Face Mask (2042F) and 3M Triple Layer Molded Face Mask Petite (2042FP)
- BioFire Diagnostics, LLC’s FilmArray Instrument (FLM1-ASY-0001)
For information on this discontinue list please click here.
If you are interested on the EUA and the 510(k) process needed to assure a smooth transition to continue market medical devices email us at: firstname.lastname@example.org and ref: device discontinue