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Zdrowie i gospodarka · 18/05/2015

FDA Releases Draft Guidance on Patient Preference Information for Medical Devices

The Food and Drug Administration (FDA) has made available a draft guidance document that outlines how patient preference information can be collected and submitted for medical devices, including those subject to premarket approval applications, humanitarian device exemptions, and de novo requests.

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