StacksVerified U.S. regulatory reference

21 CFR §809.20

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)[Reserved]
  2. (b)Compliance with good manufacturing practices. In vitro diagnostic products shall be manufactured in accordance with the good manufacturing practices requirements found in part 820 of this chapter and, if applicable, with § 610.44 of this chapter.