Section 22-B10401. PUBLIC AVAILABILITY OF REPORTS

 

10401.1The Department may disclose to the public any report, including any record of a telephone report, submitted under this part.

 

10401.2Before the Department discloses a report to the public, the Department shall delete the following:

 

(a) Any information that constitutes trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61;

 

(b) Any personal, medical, and similar information, including the serial number of implanted devices, which would constitute an invasion of personal privacy under 21 C.F.R. § 20.63.  However, if a patient requests a report, the Department shall disclose to that patient all the information in the report concerning that patient; and

 

(c) Any names and other identifying information of a third party that voluntarily submitted an adverse event report.

 

10401.3The Department shall not disclose the identity of a device user facility that makes a report under this part except in connection with:

 

(a)An action brought to enforce 21 U.S.C. § 331(q), including the failure of refusal to furnish material or information required by 21 U.S.C. § 360i;

 

(b)A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under § 10415 of this chapter; or

 

(c)A disclosure to employees of the Department of Health and Human Services, the Department of Justice, the District of Columbia Department of Health, or to the duly authorized committees and subcommittees of the Congress.

 
 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).