A facility inspection is generally not required for FDA registration itself, but it can be part of the FDA's oversight process, especially after your device is on the market. Here's how it works:

1. FDA Registration and Device Listing:
   Registering a facility and listing medical devices with the FDA is typically done electronically through the FDA's FURLS (FDA Unified Registration and Listing System). This process does not automatically trigger an FDA facility inspection.

2. Inspection as Part of Compliance:

   • The FDA may conduct inspections of your facility as part of its routine compliance and enforcement activities. This is to ensure that your manufacturing practices meet FDA’s Quality System Regulations (QSR) under 21 CFR Part 820, which are designed to ensure the safety and effectiveness of medical devices.
   • Inspections are more likely for manufacturers of Class II and Class III devices or if there are concerns regarding product quality, labeling, or safety. Class I devices, which are low risk, are less likely to be subject to inspections unless there is a reason to investigate.

3. Pre-market Approvals (PMA) or 510(k) Submissions:

   • For some high-risk devices, such as Class III devices requiring Premarket Approval (PMA), the FDA may conduct a pre-approval inspection to assess manufacturing practices and compliance with regulations.
   • Similarly, if a 510(k) submission is required for a Class II device, the FDA may inspect the manufacturing facility, especially if the device is complex or involves critical safety requirements.

4. Post-market Inspections:
   After approval or clearance, the FDA may conduct random or targeted inspections to monitor compliance, especially if complaints or adverse events arise related to your device. Manufacturers must be prepared for inspections to verify adherence to regulations such as the Quality System Regulations (QSR), labeling requirements, and reporting adverse events.

In summary, while a facility inspection is not automatically required as part of the FDA registration process, the FDA may inspect a facility as part of their oversight and compliance checks, especially for higher-risk devices or if there are concerns regarding the product’s safety and manufacturing standards.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn