[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.180]

[Page 148-149]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                           Subpart M--Records
 
Sec. 820.180  General requirements.


    All records required by this part shall be maintained at the 
manufacturing establishment or other location that is reasonably 
accessible to responsible officials of the manufacturer and to employees 
of FDA designated to perform inspections. Such records, including those 
not stored at the inspected establishment, shall be made readily 
available for review and copying by FDA employee(s). Such records shall 
be legible and shall be stored to minimize deterioration and to prevent 
loss. Those records stored in automated data processing systems shall be 
backed up.

[[Page 149]]

    (a) Confidentiality. Records deemed confidential by the manufacturer 
may be marked to aid FDA in determining whether information may be 
disclosed under the public information regulation in part 20 of this 
chapter.
    (b) Record retention period. All records required by this part shall 
be retained for a period of time equivalent to the design and expected 
life of the device, but in no case less than 2 years from the date of 
release for commercial distribution by the manufacturer.
    (c) Exceptions. This section does not apply to the reports required 
by Sec. 820.20(c) Management review, Sec. 820.22 Quality audits, and 
supplier audit reports used to meet the requirements of Sec. 820.50(a) 
Evaluation of suppliers, contractors, and consultants, but does apply to 
procedures established under these provisions. Upon request of a 
designated employee of FDA, an employee in management with executive 
responsibility shall certify in writing that the management reviews and 
quality audits required under this part, and supplier audits where 
applicable, have been performed and documented, the dates on which they 
were performed, and that any required corrective action has been 
undertaken.