21CFR Part 807 - Medical Device Listing
Manufacturers must list their devices with the FDA. Establishments required to list their devices include:
- manufacturers,
- contract manufacturers that commercially distribute the device,
- contract sterilizers that commercially distribute the device,
- repackages and relabelers,
- specification developers,
- reprocessors single-use devices,
- remanufacturer
- manufacturers of accessories and components sold directly to the end user
- U.S. manufacturers of "export only" devices
- Medical Device Listing
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Modular PMA agreement with the FDA-Organizing each Module-Manufacturing Module-Class Audit of Manufacturing Facility up to 17 days
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510(k) Applications Made Simple
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