[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: 21CFR821.55]

[Page 164-165]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821_MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                    Subpart D_Records and Inspections
 
Sec. 821.55  Confidentiality.

    (a) Any patient receiving a device subject to tracking requirements 
under this part may refuse to release, or refuse permission to release, 
the patient's name, address, telephone number, and social security 
number, or other identifying information for the purpose of tracking.
    (b) Records and other information submitted to FDA under this part 
shall be protected from public disclosure to the extent permitted under 
part 20 of this chapter, and in accordance with Sec. 20.63 of this 
chapter, information contained in such records that would identify 
patient or research subjects shall not be available for public 
disclosure except as provided in those parts.
    (c) Patient names or other identifiers may be disclosed to a 
manufacturer or other person subject to this part or to

[[Page 165]]

a physician when the health or safety of the patient requires that such 
persons have access to the information. Such notification will be 
pursuant to agreement that the record or information will not be further 
disclosed except as the health aspects of the patient requires. Such 
notification does not constitute public disclosure and will not trigger 
the availability of the same information to the public generally.

[58 FR 43447, Aug. 16, 1993, as amended at 67 FR 5951, Feb. 8, 2002]