D.C. Mun. Regs. tit. 22, r. 22-B10913

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10913 - CONFIDENTIALITY OF DATA AND INFORMATION

10913.1

The Department will not disclose the existence of an IDE unless its existence has previously been publicly disclosed or acknowledged, until DOH approves an application for premarket approval of the device subject to the IDE; or a notice of completion of a product development protocol for the device has become effective.

10913.2

The Department shall make available summaries or data under the following conditions:

(a) DOH will make publicly available, upon request, a detailed summary of information concerning the safety and effectiveness of the device that was the basis for an order approving, disapproving, or withdrawing approval of an application for an IDE for a banned device. The summary shall include information on any adverse effect on health caused by the device.

(b) If a device is a banned device or if the existence of an IDE has been publicly disclosed or acknowledged, data or information contained in the file is not available for public disclosure before approval of an application for premarket approval or the effective date of a notice of completion of a product development protocol except as provided in this section. The Department may, in its discretion, disclose a summary of selected portions of the safety and effectiveness data, that is, clinical, animal, or laboratory studies and tests of the device, for public consideration of a specific pending issue.

(c) If the existence of an IDE file has not been publicly disclosed or acknowledged, no data or information in the file are available for public disclosure except as provided in this subsection.

(d) Notwithstanding Subsection (b), the Department will make available to the public, upon request, the information in the IDE that was required to be filed in Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., Rm. 1-23, Rockville, MD 20857, for investigations involving an exception from informed consent. Persons wishing to request this information shall submit a request under the Freedom of Information Act.

10913.3

Upon request or on its own initiative, the Department shall disclose to an individual on whom an investigational device has been used a copy of a report of adverse device effects relating to that use.

10913.4

Except as otherwise provided in this section, the availability for public disclosure of data and information in an IDE file shall be handled in accordance with § 10602.

D.C. Mun. Regs. tit. 22, r. 22-B10913

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

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.