10411. EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS

10411 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. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10411