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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Page 5

 

Guide to Inspections of Medical Device Manufacturers 

 

 December 1997 

 

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 Establish and Maintain Complaint Handling Procedures - 21 CFR 820.198(a) 

The firm must have written complaint handling procedures to process information in a uniform and timely manner. Indicators that the firm may not be in compliance would be shown in the firm's failure to pursue additional follow up to determine some or all of the following complaint information: 

a. Identification of the complainant, including address and phone number and situation where reported event occurred. 

b. Identification of complaint product to the extent necessary to identify the specific device history record for the manufacture of the implicated product. 

This would be the lack of a model and serial number where one or both are necessary and the firm failed to try to obtain the information. 
c. Information needed to determine time to failure and/or if the product has failed within its warranty period. This would be the lack of a beginning use or failure date (for IVDs - the expiration date). 

d. Information to determine cycle to failure if the product's life is determined by cycle of use and not time. This would be failing to obtain how many times a mechanical device may have been used when the device has a built-in counter. 

e. Information relative to contributing factors to the reported failure mode. 

An example of this would be failing to obtain information about additional devices in use at the time, and the electrical environment during the reported failure that could be due to an Electromagnetic Compatibility (EMC) problem. 

 Determining Whether An Investigation Is Necessary - 21 CFR 820.198(b) 

The firm should evaluate complaints thoroughly to determine whether an investigation is necessary. Indicators that the firm may not be in compliance would be shown by: 

a. A history of one or more similar failure modes and has not investigated to confirm the reported failure mode. 

b. The complaint records lack the reason for not investigating and/or the name of the individual responsible for the decision not to investigate. 

If the firm states it has never received complaints and because of this it does not need a complaint handling system, it should be cited on the FDA 483 for failure to have a complaint handling system. 

 

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