The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.

FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway.

Manufacturers looking to change their device sterilization method as part of the move away from ethylene oxide (EtO) may be able to make use of the Predetermined Change Control Plan (PCCP) process, FDA officials said in a webinar this week.

The US Food and Drug Administration has granted a de novo authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first over-the-counter flu test to be cleared outside the emergency use pathway.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.

The owner of a Chicago COVID-19 testing lab plead guilty to wire fraud for billing the government for COVID-19 tests that were not performed. Also, test developer Talis Biomedical agreed to pay $32.5m to settle a shareholder suit.