The U.S. FDA announces that it is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021, titled “Remanufacturing of Medical Devices.” In a statement, the agency said that it believes that a 30-day extension “will allow adequate time for interested persons to submit comments without significantly delaying guidance on these important issues.”
This draft guidance is being issued consistent with the FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on “Remanufacturing of Medical Devices.” Moreover, the FDA says, “It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
Find more information regarding the FDA’s guidance and subsequent comment period here.