Regulation Text
(a) Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
(b) Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9 . The device is 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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.
Related Guidelines (3)
CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
→Kit Certification for 510(k)s (Status: Final)
→Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff (Status: Final)
→