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Zdrowie i gospodarka · 24.03.2014

Premarket Notification Submissions for Electrosurgical Devices for General Surgery; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery." FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →