21 CFR 1002.30
Records to be maintained by manufacturers
21 CFR 1002.30 is the regulation titled “Records to be maintained by manufacturers” in 21 CFR Part 1002, Records and Reports. 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 1020.30, 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
What FDA writes when it cites it
The finding headings that cite 21 CFR 1002.30 most often, as written in the letters.
- 1 letterthe wDR2.2 was approved and released for distribution in the US without documentation to show that the required performance standard checklist (Technical Report Subchapter J of 21 CFR MobileDiagnost wDR 2.2, Doc…
The regulation
Read the text of 21 CFR 1002.30 (eCFR, as of Sep 1, 2026)
(a) Manufacturers of products listed under table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:
(1) Description of the quality control procedures with respect to electronic product radiation safety.
(2) Records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures.
(3) For those products displaying aging effects which may increase electronic product radiation emission, records of the results of tests for durability and stability of the product, and the basis for selecting these tests.
(4) Copies of all written communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed product.
(5) Data on production and sales volume levels if available.
(b) In addition to the records required by paragraph (a) of this section, manufacturers of products listed in table 1 of § 1002.1 shall establish and maintain the following records with respect to such products:
(1) A record of the manufacturer's distribution of products in a form which will enable the tracing of specific products or production lots to distributors or to dealers in those instances in which the manufacturer distributes directly to dealers.
(2) Records received from dealers or distributors pursuant to § 1002.41.
[38 FR 28625, Oct. 15, 1973, as amended at 60 FR 48386, Sept. 19, 1995; 75 FR 16352, Apr. 1, 2010]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1002.30.
Latest letters citing it
The letter citing 21 CFR 1002.30 that FDA posted most recently.
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