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FDA Issues Final Rule Related to Medical Gases
June 17, 2024 |FDA

The FDA issued a final rule revising requirements related to current good manufacturing practice (CGMP), certification, and post-marketing safety reporting and labeling that apply to certain medical gases, it said in a notice released June 17. The final rule also establishes regulations regarding the certification of designated medical gases, and it satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act of 2017, the FDA said. The rule is effective Dec. 18, 2025, although certain amendments won't go into effect until Feb. 2, 2026.

Final Rule on Destroying Refused Medical Devices and Counterfeit Drugs Issued
May 30, 2024 by Mara Lee|FDA

A final rule that will allow the FDA to dispose of low-value medical devices and medicines more easily will take effect June 30. Currently, importers of medical devices valued at $2,500 or less have the option of re-exporting the device if it is barred from entering the U.S. In the case of drug shipments under that dollar threshold, the FDA has to prove the medicines are counterfeit, misbranded, adulterated or not approved in the U.S.; with the change, the agency will be allowed to destroy the drugs if it appears they are counterfeit, etc., unless the owner or consignee asks to testify on the medicines' admissibility.

New and Revised FDA Import Alerts for May 22
May 23, 2024 |FDA

On May 22, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of: