• 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 FDA has published the draft guidance to let more people understand its value and what FDA expectations for RRA are.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The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing.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.

• 2022-05-26 14:17:56

The US FDA offers manufacturers an opportunity to interact with FDA's experts to speed up the necessary processes for breakthrough medical devices to enter the US market. As a result, manufacturers with breakthrough medical devices have several benefits in the premarket review phase and a prioritized submission review.

• 2022-04-27 11:34:25

The US FDA is classifying the interoperable automated glycemic controller into class II. Also, the codified language for the interoperable automated glycemic controller is taken as a part of the device to the special control.

• 2022-03-25 11:58:47

The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.

• 2022-02-18 09:37:25

The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to increase related necessary medical product supply on the US market.
As the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, FDA has published a draft guidance to provide its recommendations to manufacturers, and in order to outline a roadmap for EUA devices to be able to transition after the emergency use declarations are no longer in effect in the future.

• 2022-02-18 09:29:35

Since January 18th, 2022, FDA formally classified the electrocardiograph software for over-the-counter use as class II (special controls).