StacksVerified U.S. regulatory reference

21 CFR §117.280

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
An order to withdraw a qualified facility exemption is revoked if:
  1. (a)You appeal the order and request an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10-calendar days after the hearing, or issues a decision revoking the order within that time; or
  2. (b)You appeal the order and request an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time; or
  3. (c)You appeal the order without requesting an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time.