USA – FDA Clears First COVID-19 Home Antigen Test
Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home...
USA – FDA recognizes three new international medical device software security standards
The US Food and Drug Administration (FDA) has recognized three new standards related to software security on medical devices. The standards address taking a...
Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/746
Un nouveau organisme notifié au titre du règlement (UE) 2017/746
Europe – 40ème organisme notifié au titre du règlement (UE) 2017/745
40ème ON notifié au titre du règlement 2017/745
USA – FDA reiterates guidance plans on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed...
Europe – Notified body perspective: Evaluating uses for real-world data
Real-world data (RWD) can provide useful information that may be included in clinical data submissions, but the greatest value may be during the postmarket...
USA – FDA extends regulatory flexibilities for PMA, HDE modifications
The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications...
UK – MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is taking forward its new ‘regulatory sandbox’, the AI-Airlock, that will provide a...
International – IMDRF publishes new procedures on membership, governance
The International Medical Device Regulators Forum (IMDRF) recently updated its procedures for membership and for developing and managing technical guidelines.
The 40-page Standard Operating Procedures...
Europe – Stakeholders seek short-term fixes, long-term reform for European medtech regulations
Medtech stakeholders say there needs to be a reform of the European medtech regulatory system to improve efficiency, consistency and agility.
Cracks in the current...
