lunes, 27 de enero de 2020

FDA Issues Draft Guidance on Arthroscopy Pump Tubing Sets

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/arthroscopy-pump-tubing-sets-intended-multiple-patient-use-premarket-notification-510k-submissions?utm_campaign=2020-01-27%20FDA%20Issues%20Draft%20Guidance%20on%20Arthroscopy%20Pump%20Tubing%20Sets&utm_medium=email&utm_source=Eloqua


FDA Issues Draft Guidance on Arthroscopy Pump Tubing Sets

Today, the U.S. Food and Drug Administration (FDA) issued a draft guidance to assist device developers with the preparation of premarket notification submissions (510(k)) for arthroscopy pump tubing sets intended for multiple patient use. These devices are designed to deliver irrigation fluid to the surgical site during arthroscopic procedures.

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