§ 58.107 Test and control article handling

Procedures shall be established for a system for the handling of the test and control articles to ensure that:

(a) There is proper storage.

(b) Distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage.

(c) Proper identification is maintained throughout the distribution process.

(d) The receipt and distribution of each batch is documented. Such documentation shall include the date and quantity of each batch distributed or returned.

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Warning letters citing § 58.107

2 FDA warning letters since 2017 cite this section :

• Jiangsu Kerbio Medical Technology Group Co. 11 Jul 2025
• University of Kentucky 26 Mar 2020

FDA guidance that cites § 58.107

• General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff 28 Mar 2023

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 60013 22 Dec 1978