• 2025-09-24 07:20:49

The FDA has issued draft guidance on marketing submissions for AI-enabled device software functions (AI-DSFs), with a focus on using a predetermined change control plan (PCCP). A PCCP allows manufacturers to plan and manage software changes in a predictable and controlled way, making regulatory review smoother and device performance more reliable.

• 2025-02-20 10:32:57

The FDA has released a draft on lifecycle management and marketing submission recommendations for devices that include AI-enabled software functions. This draft incorporates the Total Product Life Cycle (TPLC) approach and guiding principles for Good Machine Learning Practice (GMLP).

• 2025-01-22 03:25:25

The US FDA has released a minor update of its final guidance, Global Unique Device Identification Database (GUDID) – Guidance for Industry and FDA Staff. This update incorporates forthcoming changes to the Global Medical Device Nomenclature (GMDN) field within the GUDID, along with other minor clarifications.

• 2024-12-16 05:25:54

The FDA has introduced the Safety and Performance-Based Pathway, offering an alternative route for device clearance by focusing on performance criteria rather than direct comparison to a predicate device. This approach simplifies submissions by emphasizing established safety and performance standards, ensuring effectiveness while reducing regulatory complexities.

• 2024-11-04 05:15:38

The US FDA has issued draft guidance outlining recommended methods for chemical analysis in the biocompatibility assessment of medical devices. It advises manufacturers to use targeted analytical techniques to identify and quantify chemical constituents, focusing on both device material composition and potential patient exposure.

• 2024-10-10 08:07:48

The FDA launched the Voluntary Malfunction Summary Reporting (VMSR) program in 2018 to streamline the malfunction reporting process for medical device manufacturers. This initiative enhances the FDA's capacity to effectively monitor a diverse array of devices.

• 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

• 2024-01-26 03:40:25

The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.

• 2023-12-26 02:01:02

FDA is issuing a guidance in relation to Section 506J of Federal Food, Drug, and Cosmetic Act. In which manufacturers are required to promptly notify the FDA, whether during or prior to a Public Health Emergency (PHE), of any permanent discontinuance or interruption in the production of specific devices.

• 2023-11-20 01:26:23

Advancements in digital health technologies include the integration of AI and Machine Learning. These technologies are rapidly evolving and have a significant impact on the healthcare industry. The US FDA has released an update regarding the draft guidance they introduced on Predetermined Change Control Plans (PCCP).