D.C. Mun. Regs. tit. 22, r. 22-B10910

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

Rule 22-B10910 - DEPARTMENT OF HEALTH ACTION ON APPLICATIONS

10910.1

The Department will notify the sponsor in writing of the date it receives an application. DOH may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:

(a) Thirty (30) days after the Department receives the application at the address in § 10906 for the investigation of a device other than a banned device, unless DOH notifies the sponsor that the investigation may not begin; or

(b) The Department approves, by order, an IDE for the investigation.

10910.2

The Department may disapprove or withdraw approval of an application if it finds that:

(a) There has been a failure to comply with any requirement of this part or the act, any other applicable regulation or statute, or any condition of approval imposed by an IRB or the Department;

(b) The application or a report contains an untrue statement of a material fact, or omits material information required by this section;

(c) The sponsor fails to respond to a request for additional information within the time prescribed by the Department; and

(d) There is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained, or informed consent is inadequate, or the investigation is scientifically unsound, or there is reason to believe that the device as used is ineffective;

(e) It is otherwise unreasonable to begin or to continue the investigation owing to the way in which the device is used or the inadequacy of:

(1) The report or prior investigations or the investigational plan;

(2) The methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device; or

(3) Monitoring and reviewing the investigation.

10910.3

If the Department disapproves an application or proposes to withdraw approval of an application, the Department will notify the sponsor in writing.

(a) A disapproval order will contain a complete statement of the reasons for disapproval and a statement that the sponsor has an opportunity to request a hearing under 21 C.F.R., part 16.

(b) A notice of a proposed withdrawal of approval will contain a complete statement of the reasons for withdrawal and a statement that the sponsor has an opportunity to request a hearing. The Department will provide the opportunity for hearing before withdrawal of approval, unless the Department determines in the notice that continuation of testing under the exemption will result in an unreasonable risk to the public health and orders withdrawal of approval before any hearing.

D.C. Mun. Regs. tit. 22, r. 22-B10910

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.