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FAQ:
Q: What happens if I don’t meet the requirements of part 493?
A: (e)Failure to meet the applicable requirements of part 493, will result in an action by HHS to suspend, revoke or limit the certificate of accreditation. HHS will –
Q: What does § 493-553 mean?
A: § 493.553 Approval process (application and reapplication) for accreditation organizations and State licensure programs. (a)Information required.
Q: What is § 493 15 of the FDA?
A: § 493.15 Laboratories performing waived tests. (a)Requirement. Tests for certificate of waiver must meet the descriptive criteria specified in paragraph (b)of this section. (b)Criteria. Test systems are simple laboratory examinations and procedures which – (1)Are cleared by FDA for home use;
Q: What does § 493 1251 standard mean?
A: § 493.1251 Standard: Procedure manual. (a)A written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory’s written procedures for testing or examining specimens.