21 CFR § 880.6280 - Medical insole.
§ 880.6280 Medical insole.
(a) Identification. A medical insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.
(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 the limitations in § 880.9.