21 C.F.R. § 880.6280 Medical insole.
Title 21 - Food and Drugs
(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. [45 FR 69682–69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38806, July 25, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart G—General Hospital and Personal Use Miscellaneous Devices
§ 880.6280 Medical insole.
