FDA’s AI/ML Action Plan Includes ‘Tailored’ Regulatory Framework for SaMD
On January 18th 2021, the US Food and Drug Administration (FDA) released a five-part action plan for their artificial intelligence and machine learning (AI/ML) software and classified it as a medical device (SaMD).
How to make a Home-Made Face Mask: Health Authorities Recommendations
Learn how to make a home-made face mask based on health authority recommendations around the world.
New FDA Pilot Program for 510(k) “Quik” Review
FDA has launched a new pilot program for a “Quick Review“ of 510(k) of certain medical devices, by using the eSubmitter software to format the submission. The devices that qualify for this quick review, as shown on list below, are moderate risk devic…
FDA Publishes a New List of Class II 510(K) Exempted Devices
[vc_row][vc_column width=”1/2″][vc_column_text] FDA Publishes a New List of Class II 510(K) Exempted Devices On July 11, 2017, the US Food and Drug Administration (FDA) has finalized the list of 1,003 types of class II 510(K) exempted medical devices. According to the agency these devices do not present risks that require premarket notification review to provide […]
FDA Publishes new list of Class II devices exempted from 510(K) submission
Chinese Regulators May be Abolishing Medical Device Testing Fees
In late March, the Chinese Ministry of Finance announced that it will abolish several government fees, including medical device testing fees associated with CFDA registration. The new policy went into effect April 1, 2017. So far, only the CFDA’s Shanghai testing center has officially implemented this change, the other testing laboratories in Beijing and Zhejiang […]