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. You must submit the request to us in writing. Your request must include inf
