Section 22-B10908. INVESTIGATIONAL PLAN

 

10908.1The investigational plan shall include, in the following order:

 

(a)The name and intended use of the device and the objectives and duration of the investigation;

 

(b)A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound;

 

(c)A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized; a justification for the investigation; and a description of the patient population, including the number, age, sex, and condition;

(d)A description of each important component, ingredient, property, and principle of operation of the device and of each anticipated change in the device during the course of the investigation;

 

(e)The sponsor's written procedures for monitoring the investigation and the name and address of any monitor;

 

(f)Copies of all labeling for the device;

 

(g)Copies of all forms and informational materials to be provided to subjects to obtain informed consent;

 

(h)A list of the names, locations, and chairpersons of all IRBs that have been or will be asked to review the investigation, and a certification of any action taken by any of those IRBs with respect to the investigation;

 

(i) The name and address of each institution at which a part of the investigation may be conducted that has not been identified in § 10908.1(h); and

 

(j)A description of records and reports that will be maintained on the investigation in addition to those prescribed in §§ 10927, 10928, and 10929.

 

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).