21 CFR 864.3010
§ 864.3010 Tissue processing equipment.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.3010, § 864.3010 Tissue processing equipment, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89317
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Full text
(a) Identification. Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
(b) Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The devices are also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.