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FDA registration and certification for medical devices in the United States involves a regulatory process to ensure that medical devices meet safety and effectiveness standards before they can be marketed. Here’s a breakdown:

1. FDA Registration:

   • Device Listing: Manufacturers must register their device and facility with the FDA. This includes providing basic information about the device, its intended use, and the manufacturer’s details. Registration must be updated annually.

2. FDA Certification:

   • 510(k) Premarket Notification: For most Class II devices, manufacturers must submit a 510(k) application demonstrating that the device is substantially equivalent to an already marketed device (predicate device). This process typically takes around 90 days.
   • Premarket Approval (PMA): For Class III devices, which are higher risk, a more comprehensive review process is required. This involves submitting extensive clinical data and device information for approval, which can take several months to over a year.
   • De Novo Classification: For novel devices without a predicate, manufacturers can request a new classification through a De Novo submission. This process also involves detailed safety and effectiveness data and usually takes 6 to 12 months.

3. Quality System Regulations (QSR):

   • Manufacturers must comply with FDA’s Quality System Regulations (QSR), which cover aspects such as design controls, production processes, and documentation to ensure device safety and effectiveness.

4. FDA Inspections:

   • The FDA may inspect manufacturing facilities to ensure compliance with QSR and other regulatory requirements.

These processes ensure that medical devices meet FDA standards before being sold in the U.S. market.

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