(71 days)
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§ 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). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is 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.