[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

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]