⚙️FDA Modifies Recognized Standards for Medical Devices
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 063
Summary
The Food and Drug Administration (FDA or 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: 063" (Recognition List Number: 063), 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
This notice outlines modifications to recognized standards applicable to medical devices, which directly impacts manufacturers' compliance with FDA regulations. It also emphasizes the need for businesses to stay updated on recognized standards to ensure conformity in premarket submissions.