Re: Adult Diaper & Medical Device requirements
You're in luck. This device (and it is a device) has been exempted from everthing. Read directly from CDRH Website:
Sec. 876.5920 Protective garment for incontinence.
(a)Identification. A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
garment, protective, for incontinence
Regulation Description Protective garment for incontinence.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product Code EYQ
Submission Type 510(k) Exempt
Regulation Number 876.5920
Device Class 1
GMP Exempt? Yes
Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Note: FDA has exempted almost all class I devices (with the exception of Reserved Devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment. Please see the Registration and Listing website for additional information.
Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence