D.C. Mun. Regs. tit. 22, r. 22-B10411

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

Rule 22-B10411 - EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS

10411.1

The following persons are exempt from the adverse event reporting requirements of this section:

(a) A licensed practitioner who prescribes or administers devices intended for use in humans and manufactures or imports devices solely for use in diagnosing and treating persons with whom the practitioner has a "physician-patient" relationship;

(b) An individual who manufactures devices intended for use in humans solely for the individual's use in research or teaching and not for sale. This includes any person who is subject to alternative reporting requirements under the investigational device exemption regulations, which require reporting of all adverse device effects; and

(c) Dental laboratories or optical laboratories.

10411.2

If you are a manufacturer, importer, or user facility, you may request an exemption or variance from any or all of the reporting requirements in this section. You must submit the request to the Department in writing. Your request must include information necessary to identify you and the device; a complete statement of the request for exemption, variance, or alternative reporting; and an explanation why your request is justified.

10411.3

The Department may grant, in writing, to a manufacturer, importer, or user facility, an exemption or variance from, or alternative to, any or all of the reporting requirements in this section and may change the frequency of reporting to quarterly, semiannually, annually, or any other appropriate time period. The Department may grant these modifications in response to a request made pursuant to § 10411.2, or at the Department's discretion. When the Department grants modifications to the reporting requirements, we may impose other reporting requirements to ensure the protection of public health.

10411.4

The Department may revoke or modify in writing an exemption, variance, or alternative reporting requirement if the Department determines that revocation or modification is necessary to protect the public health.

10411.5

If the Department grants your request for a reporting modification, you must submit any reports or information required in our approval of the modification. The conditions of the approval will replace and supersede the regular reporting requirement specified in this part until such time that the Department revokes or modifies the alternative reporting requirements in accordance with § 10411.4.

D.C. Mun. Regs. tit. 22, r. 22-B10411

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.