FDA Issues Draft Guidance on Discontinuance or Interruption of Manufacturing of Certain Devices Implementing CARES Act
Arnold Porter
JANUARY 24, 2022
For purposes of the Draft Guidance, FDA interprets the term "manufacturer" to mean the entity that holds the medical device marketing submission authorization; if a medical device marketing submission is not required, the "manufacturer" is the entity responsible for listing the medical device under section 510(j) of the FDCA.
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