Important Considerations for Defining Medical Device Accessories and Classification Pathway for New Accessory Types

Important Considerations for Defining Medical Device Accessories and Classification Pathway for New Accessory Types
Publish Date:
April 20, 2015
Authors:
Prithul Bom, MBA, RAC, Director, Medical Device and Diagnostic Development

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued the draft guidance, “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” This is an important guidance to stakeholders as it clarifies how the FDA’s traditional risk- and regulatory control-based classification approach applies to a medical device accessory, and helps stakeholders understand how the FDA may evaluate such devices going forward. Because the FDA follows a risk- and regulatory control-based classification approach, risks associated with an accessory are those it presents when used with the parent device as intended by the manufacturer.