Section 22-B10901. APPLICABILITY

 

10901.1This chapter applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in § 10901.3.

 

10901.2The following categories of investigations are considered to have approved applications for IDE unless the Department has notified a sponsor under § 10907.1(a) that approval of an application is required:

 

(a)An investigation of a device other than a significant risk device, if the device is not a banned device and the sponsor:

 

(1)Labels the device in accordance with § 10902;

 

(2)Obtains investigational review board (IRB) approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintains such approval;

 

(3) Ensures that each investigator participating in a § 10907.1(a) investigation of the device obtains from each subject under the investigator's care, informed consent and documents it, unless documentation is waived by an IRB under 21 CFR § 56.109(c).

 

(4)Complies with the requirements of § 10918 with respect to monitoring investigations;

 

(5)Maintains the records required under § 10927.2(d) and (e) makes the reports required under § 10929.2 (a)-(c) and (e)-(j);

 

(6)Ensures that participating investigators maintain the records required by § 10927.1(c)(1) and make the reports required under § 10929.1(a), (b), (e), and (g); and

 

(7)Complies with the prohibitions in § 10903 against promotion and other practices; and

 

(b)An investigation of a device other than one subject to § 10901.5, if the investigation was begun on or before July 16, 1980, and to be completed, and is completed, on or before January 19, 1981.

 

10901.3This chapter, with the exception of § 10926, does not apply to investigations of the following categories of devices:

 

(a)A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time;

 

(b)A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that the Department has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling the Department reviewed under §§ 10512 through 10521 in determining substantial equivalence;

 

(c)A diagnostic device, if the sponsor complies with applicable requirements in § 10901.3(h) and if the testing:

 

(1)Is noninvasive,

 

(2)Does not require an invasive sampling procedure that presents significant risk,

 

(3)Does not, by design or intention, introduce energy into a subject, and

 

(4)Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure;

 

(d)A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two (2) or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;

 

(e)A device intended solely for veterinary use;

 

(f)A device shipped solely for research on or with laboratory animals and labeled in accordance with § 10902.3;

 

(g)A custom device as defined in § 10999, unless the device is being used to determine safety or effectiveness for commercial distribution; and

 

(h)A shipment or other delivery of an in vitro diagnostic product shall:

 

(1)For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: “For Research Use Only. Not for use in diagnostic procedures.”; and

 

(2)For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: “For Investigational Use Only. The performance characteristics of this product have not been established.”.

 

10901.4In the case of a class II or class III device described in § 10901.3(a) or (b), this section applies beginning on the date stipulated in a Department regulation or order that calls for the submission of premarket approval applications for an unapproved class III device, or establishes a performance standard for a class II device.

 

10901.5A sponsor that, on July 16, 1980, has an effective investigational new drug application (IND) for an investigation of a device shall continue to comply with the requirements of 21 C.F.R., part 312 until ninety (90) days after that date. To continue the investigation after that date, a sponsor shall comply with § 10901.2(a), if the device is not a significant risk device, or shall have obtained Department approval under § 10910 of an IDE application for the investigation of the device.

 

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).