FDA cGMP on Feedback, Advisory Notice and Customer Property

somashekar

Staff member
Super Moderator
#1
I request help from experts about where in the FDA cGMP document / or other parts, the following have been mentioned.
1. Customer property as in ISO 13485, clause 7.5.4
2. Feedback as in ISO 13485, clause 8.2.1
3. Advisory notices as in ISO 13485, clause 8.5.1

:thanx:
 
Last edited:
Elsmar Forum Sponsor

Sam Lazzara

Trusted Information Resource
#2
Hello Soma,

1. No CFRs specific to this matter (to my knowledge). FDA does not have the authority to protect customer property.

2. 820.198 for product complaints. The "early warning" aspect is not covered in 820 but there is the possiblility of post market surveillance studies being required per PMA approval conditions under authority of FD&C Act (aka The Law).
http://www.fda.gov/MedicalDevices/D...irements/PostmarketSurveillance/ucm134497.htm

3. 21 CFR Part 806: Medical Device Corrections and Removals
 

Ajit Basrur

Staff member
Admin
#3
I request help from experts about where in the FDA cGMP document / or other parts, the following have been mentioned.
1. Customer property as in ISO 13485, clause 7.5.4
2. Feedback as in ISO 13485, clause 8.2.1
3. Advisory notices as in ISO 13485, clause 8.5.1

:thanx:
In addition to Sam, you could find some references here -

1. Customer property - FDA Staff Manual, SMG 2020, where it is mentioned under 3.4

(e) If the customer supplies the organization with information or material (example: trade secret information), determine

(1) if it needs protection and, if so, how to identify and safeguard the property; and

(2) how to notify the customer if the property is unsuitable, lost, or harmed; and maintain records of any notifications.​

3. Advisory notices - the GHTF document, GHTFISG2/N54R8:2006 applies.

.
 
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