[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: 21CFR821.55]

[Page 158]
 
                        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) 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.
    (b) Patient names or other identifiers may be disclosed to a 
manufacturer or other person subject to this part or to 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.

    Effective Date Note: At 67 FR 5952, Feb. 8, 2002, Sec. 821.55 was 
amended by redesignating paragraphs (a) and (b) as paragraphs (b) and 
(c), respectively, and by adding a new paragraph (a), effective May 9, 
2002. For the convenience of the user, the added text is set forth as 
follows:

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.

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