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Title 21Chapter ISubchapter HPart 803Subpart A → §803.19

Title 21: Food and Drugs
Subpart A—General Provisions

§803.19   Are there exemptions, variances, or alternative forms of adverse event reporting requirements?

(a) We exempt the following persons from the adverse event reporting requirements in this part:

(1) 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;

(2) An individual who manufactures devices intended for use in humans solely for this person'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 (described in part 812 of this chapter), which require reporting of all adverse device effects; and

(3) Dental laboratories or optical laboratories.

(b) 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 part, including the requirements of §803.12. You must submit the request to us in writing at the following address: MDR Exemption Requests, Office of Surveillance and Biometrics, 10903 New Hampshire Ave., Bldg. 66, Rm. 3217, Silver Spring, MD 20993-0002. 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. If you are requesting an exemption from the requirement to submit reports to FDA in electronic format under §803.12(a), your request should indicate for how long you will require this exemption.

(c) If you are a manufacturer, importer, or user facility, we may grant in writing an exemption or variance from, or alternative to, any or all of the reporting requirements in this part, and may change the frequency of reporting to quarterly, semiannually, annually or other appropriate time period. We may grant these modifications in response to your request, as described in paragraph (b) of this section, or at our discretion. When we grant modifications to the reporting requirements, we may impose other reporting requirements to ensure the protection of public health.

(d) We may revoke or modify in writing an exemption, variance, or alternative reporting requirement if we determine that revocation or modification is necessary to protect the public health.

(e) If we grant 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 we revoke or modify the alternative reporting requirements in accordance with paragraph (d) of this section or until the date specified in our response granting your variance, at which time the provisions of this part will again apply.

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