Title 21 Part 880 → Subpart F → §880.5680

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5680

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5680

e-CFR data is current as of July 12, 2019

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5680

Title 21: Food and Drugs
Subpart F—General Hospital and Personal Use Therapeutic Devices

§880.5680   Pediatric position holder.

(a) Identification. A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.

(b) Classification. Class I (general controls). The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001]