We at Emergo by UL would like to point out that the U.S. Food and Drug Administration (FDA) has recently adapted certain searches and information to highlight regulatory guidance for specific medical device types. Medical device and IVD manufacturers who want to stay ahead of regulatory changes to avoid market access disruptions should take note.
Searching FDA guidance documents
The U.S. FDA has separated the "Search for FDA Guidance Documents" two sections by whether special controls are applicable or not:
- A search specific for guidance documents on Class II Special Controls Documents for specific device types
- A search for other guidance documents
The Class II Special Controls Documents, now a separate search (page, with a link from the main search page), provides guidance documents that mandate special controls.
The main search for guidance documents must still be utilized to provide standards that apply to many device types, such as biocompatibility, sterilization, software, cybersecurity, etc. It is important to note that this main search also includes Safety and Performance Based Pathway Guidance documents.
US FDA Reorganizes Medical Device Guidance Databases | Emergo by UL
US FDA Reorganizes Medical Device Guidance Databases
This regulatory update discusses how the U.S. Food and Drug Administration (FDA) recently adapted certain searches and information to highlight regulatory guidance for specific medical device types.
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