The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more
The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more