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Zdrowie i gospodarka · 16/10/1998

FDA Announces Updates to Medical Device Standards and Withdraws Draft Guidance

The Food and Drug Administration (FDA) has published modifications to the list of recognized standards for medical devices and withdrawn its draft guidance on using IEC 60601 standards for medical electrical equipment, aiming to simplify the premarket review process for manufacturers.

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