• 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.

• 2022-11-29 02:56:30

Japan's Ministry of Health, Labour and Welfare announced that Japan's standard for medical device usability engineering (JIS T 62366-1) has been amended.

• 2022-09-27 07:17:48

Utilization of Remote Regulatory Assessments (RRA) as a critical examination of an FDA-regulated establishment and/or its records. FDA has published the draft guidance to let more people understand its value and what FDA expectations for RRA are.

• 2022-09-27 07:07:49

The Food and Drug Administration (FDA) established a new regulatory category for over-the-counter (OTC) hearing aids. The new policy will redefine OTC hearing aids and change the current rules as well as modify the obsolete old rules. FDA believes this method will ensure the OTC hearing aids with innovative technology provide reasonable safety and effectiveness, while promoting public health.

• 2022-07-26 11:26:52

According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.

• 2022-06-29 03:18:32

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.