D.C. Mun. Regs. tit. 22, r. 22-B10627

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

Rule 22-B10627 - DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION

10627.1

The Department may deny approval or withdraw approval of an application if the applicant fails to meet the requirements of 21 U.S.C. § 360j(m) or of any condition of approval imposed by an IRB or by the Department, or any post-approval requirements imposed under § 10631. In addition, the Department may deny approval or withdraw approval of an application if, upon the basis of the information submitted in the HDE or any other before the agency, the Department determines that:

(a) There is a lack of a showing of reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(b) The device is ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

(c) The applicant has not demonstrated that there is a reasonable basis from which to conclude that the probable benefit to health from the use of the device outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment;

(d) The application or a report submitted by or on behalf of the applicant contains an untrue statement of material fact, or omits material information;

(e) The device's labeling does not comply with the requirements in Chapter 103;

(f) A nonclinical laboratory study that is described in the HDE and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study;

(g) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in § 10631 or the informed consent regulations in 21 C.F.R., part 50, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected;

(h) The applicant does not permit an authorized Department employee an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and controls, and to have access to and to copy and verify all records pertinent to the application; or

(i) The device's HUD designation should be revoked in accordance with § 10619.3.

10627.2

If the Department issues an order denying approval of an application, the agency will comply with the same notice and disclosure provisions required for PMAs under §§ 10612.2 and 10612.4, as applicable.

10627.3

The Department will issue an order denying approval of an HDE after an approvable or not approvable letter has been sent and the applicant. The following also applies:

(a) Submits a requested amendment but any ground for denying approval of the application under § 10627.1 still applies;

(b) Notifies the Department in writing that the requested amendment will not be submitted; or

(c) Petitions for review under 21 U.S.C. § 360e(d)(3) by filing a petition in the form of a petition for reconsideration under 21 C.F.R. § 10.33.

10627.4

Before issuing an order withdrawing approval of an HDE, the Department will provide the applicant with notice and an opportunity for a hearing as required for PMAs under §§ 10613.3 and 10613.4, and will provide the public with notice in accordance with § 10613.5, as applicable.

D.C. Mun. Regs. tit. 22, r. 22-B10627

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.