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Adult Diaper & Medical Device requirements - Page 2


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  Post Number #9  
Old 18th June 2009, 01:19 PM
MIREGMGR

 
 
Total Posts: 3,475
Re: Adult Diaper & Medical Device requirements

If FDA regulation is relevant, you might want to review Product Code EYQ.

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  Post Number #10  
Old 18th June 2009, 02:24 PM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 601
Re: Adult Diaper & Medical Device requirements

Adult diaper is a medical device classified in FDA, PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES, Subpart F--Therapeutic Devices, 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.

(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 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records, and 820.198, regarding complaint files.

Thanks and Regards
S. Subramaniam

Last edited by bio_subbu; 18th June 2009 at 02:26 PM. Reason: Rephrased the sentences
Thank You to bio_subbu for your informative Post and/or Attachment!
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  Post Number #11  
Old 21st June 2009, 03:30 AM
DRDDO

 
 
Total Posts: 94
Re: Adult Diaper & Medical Device requirements

Quote:
In Reply to Parent Post by bio_subbu View Post

Adult diaper is a medical device classified in FDA, PART 876 -- GASTROENTEROLOGY-UROLOGY DEVICES, Subpart F--Therapeutic Devices, 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.

(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 876.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records, and 820.198, regarding complaint files.

Thanks and Regards
S. Subramaniam
Profesiional information

DRDDO
  Post Number #12  
Old 21st June 2009, 03:36 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,757
Re: Adult Diaper & Medical Device requirements

Thanks subbu
  Post Number #13  
Old 21st June 2009, 09:19 AM
DRDDO

 
 
Total Posts: 94
Re: Adult Diaper & Medical Device requirements

Quote:
In Reply to Parent Post by Ajit Basrur View Post

Thanks subbu
Thanks you too
DRDDO
  Post Number #14  
Old 22nd June 2009, 12:36 PM
Watchwait's Avatar
Watchwait

 
 
Total Posts: 247
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.
Guidance Document

Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence
Thank You to Watchwait for your informative Post and/or Attachment!
  Post Number #15  
Old 22nd June 2009, 01:08 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,757
Re: Adult Diaper & Medical Device requirements

Hi Watchwait,

Thanks for the detailed info
Reply

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