Industry News

Latest COVID-19 Information from the FDA (2020.11.9-11.13)

Update time : 2020-11-13 14:56:02

The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.

Let’s have a quick news review of this week from FDA.

Previous : How to distinguish the authenticity of FDA Authorization?

Next : FDA tell you how to use non-contact infrared thermometers (NCITs) properly

AOJ Medical upgrades its molding factory with 40% increase in capacity

Nov .26.2020

AOJ Medical has 3 anti-static production workshops (7 production lines) and 1 molding factory. The workshops occupy an area of 5000 square meters.

FDA tell you how to use non-contact infrared thermometers (NCITs) properly

Nov .12.2020

Correct Use – Forehead unobstructed, and NCIT perpendicular to forehead and used at distance identified in manufacturer’s instructions.

How to distinguish the authenticity of FDA Authorization?

Nov .10.2020

FDA officials have not issued any certificates to manufacturers of Class II medical devices. The so-called FDA certificates are all counterfeit. The manufacturer provides a 510k number, which can be checked on the FDA official website.

The application of the EU's delayed medical device regulations will not be affected by qualified CE certification bodies in the short term

Jul .21.2020

According to the news published by the European Commission on its official website on April 3, 2020, the European Commission will delay the application of the "Medical Device Regulation" (MDR) originally scheduled to come into effect on May 26, 2020, and