⚕️FDA Modifications to Recognized Standards on Medical Devices
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 064
Summary
The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 064" (Recognition List Number: 064), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document outlines modifications to the FDA's list of recognized standards for medical devices, which impacts manufacturers' compliance with premarket review requirements. These changes necessitate adjustments in production and regulatory processes, indicating a significant business impact.