21 CFR § 1.610 General Enforcement Regulations

§ 1.610 Who is eligible to seek recognition?

Current through Sep 8, 2026 · Read all of Part 1

⚠ 1 pending change to Part 1

An accreditation body is eligible to seek recognition by FDA if it can demonstrate that it meets the requirements of §§ 1.611 through 1.615. The accreditation body may use documentation of conformance with International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17011:2004, supplemented as necessary, in meeting the applicable requirements of this subpart.

← § 1.601 Who is subject to this subpart?§ 1.611 What legal authority must an accreditation body have to qualify for recognition? →