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Zdrowie i gospodarka · 03/02/1999

Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA).'' Under the Sectoral Annex on Medical Devices (Annex), FDA has agreed to designate conformity assessment bodies (CAB's) as third parties (i.e., organizations outside of FDA) authorized to perform premarket and quality system evaluations consistent with the Annex. This guidance will assist those who are interested in participating in this program as CAB's or as applicants pursuing premarket and quality system evaluations consistent with the Annex.

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