Companies marketing integral drug-device combination products who want to make changes to the medicinal component might need to obtain a new/updated opinion from a notified body (NB) about the product’s device portion, the European Medicines Agency has clarified in a newly revised Q&A document.
EMA Answers More Questions For Manufacturers of Drug-Device Combos
Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.
More from Europe
More from Geography
• By
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.
• By
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
• By
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.