King & Spalding partner Kyle Sampson tells Medtech Insight that a joint HHS/FDA notice that could exempt a plethora of medical devices from premarket review falls under a recent regulatory freeze from the Biden administration.

The US agency has announced another month of webinars aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.

ANSI/AAMI ST79:2017 has gained four new amendments, including recommendations and clarifications for “maintaining the integrity” of sterile process areas. The standard is used by health care professionals who use steam to sterilize devices and other medical products.