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The FDA CARES Act requires drug manufacturers, repackers and relabelers to submit annual reports on drug production volumes. Here are the key points: Deadline: July 31, 2024, for the 2023 calendar year; Who Must Report: All FDA-registered facilities under section 510(j)(3) of the Federal Food, Drug & Cosmetic Act; What to Report: Annual production volumes for each listed drug.
On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance patient safety, improve post-market surveillance, and facilitate the identification of medical devices. The UDI system requires manufacturers to assign a...
What are the potential consequences for medical device manufacturers not following through with product data submissions and labeling requirements? In a recent inspection, violations were identified regarding a manufacturer’s Unique Device Identification (UDI)...
In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without Unique Device Identification (UDI) as of the Compliance Date, commonly referred to as the 3-Year Inventory UDI Exception or the ‘Final Rule.’ Such devices meeting the criteria could be commercially distributed for 3 years after the corresponding Compliance Date without complying with UDI requirements. At the end of the 3-year period, any undistributed inventory would need to be reprocessed to comply with current UDI requirements, i.e., UDI Label and GUDID reporting.
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’. Intended Use and Indications for Use are key determiners and FDA provides clear guidance. Packaging and accessory definitions can be reasons for...
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements of multiple regulatory agencies. An important component of achieving regulatory approval is a classification of the medical device, according to the...
Did you know there are multiple health authorities around the globe with current or future requirements for medical device product data specifically for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS,...
Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...