21 CFR 803.19
Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
21 CFR 803.19 is the regulation titled “Are there exemptions, variances, or alternative forms of adverse event reporting requirements?” in 21 CFR Part 803, Medical Device Reporting. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 803.12, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 12025
- 02026
The regulation
Read the text of 21 CFR 803.19 (eCFR, as of Sep 1, 2026)
(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 the Center for Devices and Radiological Health (CDRH) in writing at MDRPolicy@fda.hhs.gov. 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.
[79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 2, 2020; 88 FR 16879, Mar. 21, 2023]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 803.19.
- 21 CFR 803.12How do I submit initial and supplemental or followup reports?1 letter cites both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 803.3How does FDA define the terms used in this part?1 letter cites both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?1 letter cites both
- 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
Latest letters citing it
The letter citing 21 CFR 803.19 that FDA posted most recently.
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