For patient safety, the US Food and Drug Administration should require that clinical data be submitted as part of a more rigorous re-evaluation of medical devices that are modified after approval. According to authors of a new expert opinion, such a requirement could prevent deaths due to insufficiently tested device modifications.
Fuente : http://feeds.sciencedaily.com/~r/sciencedaily/~3/6...
Fuente : http://feeds.sciencedaily.com/~r/sciencedaily/~3/6...