{"id":8970,"date":"2019-03-01T17:16:59","date_gmt":"2019-03-01T16:16:59","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8970"},"modified":"2023-01-24T15:02:06","modified_gmt":"2023-01-24T14:02:06","slug":"unclassified-medical-device-exemption-from-premarket-notification-requirements-fda-updates-guidance","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2019\/03\/01\/unclassified-medical-device-exemption-from-premarket-notification-requirements-fda-updates-guidance\/","title":{"rendered":"Unclassified medical device exemption from Premarket Notification requirements: FDA updates guidance"},"content":{"rendered":"\n

To streamline the medical device approval\nprocess and bring treatments to patients who need them faster and more\nefficiently, the US FDA was given the authority to exempt class I and II\ndevices from premarket notification requirements on a periodic basis under the\n21st Century Cures Act. <\/p>\n\n\n\n

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Esenzione dai requisiti di Premarket Notification per i dispositivi medici non classificati: FDA aggiorna la guidance<\/em><\/figcaption><\/figure>\n\n\n\n

Committed to their goal, the FDA identified certain low-risk medical devices for which the premarket notification was deemed not necessary to ensure their safety and effectiveness before their placement on the market and, on February 8, 2019, released an updated guidance \u201cIntent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements<\/a><\/em>\u201d. <\/p>\n\n\n\n

Consequently, the FDA intends to classify as\nclass I and II the following (unclassified) medical devices, listed under\nSection IV of the guidance: <\/p>\n\n\n\n