§880.1. Scope. — Inbound Citations

(2) “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for use by the General Public in Public Health Medical Emergencies.” See § 880.1(e) for information on obtaining a copy of this guidance document.

(b) Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

(b) Class II (special controls). The special control is: The FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Remote Medication Management System.” See § 880.1(e) for availability of this guidance document.