[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.12]

[Page 169]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822_POSTMARKET SURVEILLANCE--Table of Contents
 
                 Subpart C_Postmarket Surveillance Plan
 
Sec. 822.12  Do you have any information that will help me prepare my
submission or design my postmarket surveillance plan?

    Guidance documents that discuss our current thinking on preparing a 
postmarket surveillance submission and designing a postmarket 
surveillance plan are available on the Center for Devices and 
Radiological Health's Web site and from the Center for Devices and 
Radiological Health, Office of Surveillance and Biometrics (HFZ-510), 
1350 Piccard Dr., Rockville, MD 20850. Guidance documents represent our 
current interpretation of, or policy on, a regulatory issue. They do not 
establish legally enforceable rights or responsibilities and do not 
legally bind you or FDA. You may choose to use an approach other than 
the one set forth in a guidance document, as long as your alternative 
approach complies with the relevant statutes (laws) and regulations. If 
you wish, we will meet with you to discuss whether an alternative 
approach you are considering will satisfy the requirements of the act 
and regulations.