[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR806.30]

[Page 58]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS--Table of Contents
 
                     Subpart B--Reports and Records
 
Sec. 806.30  FDA access to records.

    Each device manufacturer or importer required under this part to 
maintain records and every person who is in charge or custody of such 
records shall, upon request of an officer or employee designated by FDA 
and under section 704(e) of the act, permit such officer or employee at 
all reasonable times to have access to, and to copy and verify, such 
records and reports.

[63 FR 42233, Aug. 7, 1998]