FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.
”The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).
The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspections. (RELATED: FDA Drafts Guidance on Inspections of Medical Device Establishments, Regulatory Focus 28 March 2019)”