• 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The FDA has issued a draft guidance to clarify how it reviews real-world data, ensuring its quality for generating evidence that can inform regulatory decisions on medical devices.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 The US FDA has released an update regarding the draft guidance they introduced on Predetermined Change Control Plans (PCCP).

• 2023-10-20 05:56:00

The US FDA issued a draft guidance for medical devices that have relation to Weight Loss. The purpose of this guidance is to provides recommendations for both clinical and non-clinical testing to support premarket submissions.

• 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

• 2023-07-21 02:14:29

The US FDA recently issued an updated guidance aimed at providing comprehensive information on the recommended documentation for premarket submissions. The purpose of this guidance is to assist the FDA in evaluating the safety and effectiveness of device software functions.

• 2023-06-28 07:24:11

The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices

• 2023-03-27 08:22:41

The US FDA starts to launch the so-called "eSTAR" Pilot with Health Canada. The eSTAR is an interactive medical device submission process and is expected to likely become the main path regarding medical device submissions for 510(k) and De novo registrations in the near future.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.