(a) Identification. A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 880.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of Sec. 820.180 of this chapter, with respect to general requirements concerning records, and Sec. 820.198 of this chapter, with respect to complaint files. [45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]