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The firm’s CAPA procedures and lack of written MDR procedures were among the nonconformities flagged on more than one occasion after FDA inspections. Read More
Health Canada pointed to the last paragraph in the Food and Drugs Act’s definition of a medical device as a significant 2014 addition intended to help distinguish between products. Read More
Brazil has made a number of regulatory changes aimed at simplifying market entry for foreign devicemakers, such as getting rid of certain import requirements. Read More
A successful paradigm shift focusing on software is heavily dependent on collaborative interactions, said Bakul Patel, CDRH’s associate director for digital health. Read More
The diagnostic agent has “the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for… Read More
A devicemaker’s manufacturing facility in Oregon was cited for closing customer complaint investigations without documenting the changes identified for addressing the issues or verifying their effectiveness. Read More
The FDA issued a Form 483 flagging several GMP and MDR nonconformities — most of which are repeat observations — at a Zimmer Biomet medical device manufacturing facility in Indiana. Read More