Yes, a facility inspection is often required for FDA certification in the United States, especially for certain types of devices. Here’s when a facility inspection might be required:

1. Premarket Approval (PMA) and 510(k) Submissions

• Class III Devices (PMA): For high-risk devices that require Premarket Approval (PMA), the FDA often conducts a facility inspection as part of the approval process. This inspection ensures that the manufacturing facility complies with FDA’s Good Manufacturing Practices (GMP), also known as Quality System Regulations (QSR).
• Class II Devices (510(k)): While the FDA typically does not conduct routine facility inspections as part of the 510(k) submission process, they may inspect the manufacturing facility if concerns arise during the review, or if the FDA wants to verify compliance with QSR.

2. Good Manufacturing Practices (GMP) / Quality System Regulations (QSR) Compliance

• FDA Inspections for Compliance: Any facility that manufactures, processes, packs, or holds FDA-regulated products is subject to FDA inspections to ensure compliance with 21 CFR Part 820 (Quality System Regulations). These inspections check if the facility is following FDA standards for device manufacturing, including design controls, production controls, and recordkeeping.
• Frequency of Inspections: FDA inspections can occur at any time during the device lifecycle, whether before, during, or after the device is marketed. Inspections are typically conducted every 2 to 3 years, but they can be more frequent if the FDA deems it necessary, especially if there are reports of violations or issues.

3. Inspection After Device Approval

• Even if the FDA has already granted approval (PMA or 510(k)), the facility may still be inspected to verify ongoing compliance with GMP/QSR. The FDA can inspect:
  • Manufacturing facilities
  • Labeling and packaging areas
  • Sterility testing and validation processes (for sterile devices)

4. Inspections for Foreign Manufacturers

• International Manufacturers: If the manufacturer is located outside the United States, the FDA may still require an inspection before granting FDA approval. In some cases, the FDA may conduct the inspection through third-party organizations or collaborate with regulatory bodies in other countries.

5. Inspections for New or Modified Devices

• If a manufacturer introduces a new or modified device, the FDA may conduct an inspection to ensure compliance with regulatory standards before the device can be marketed.

Conclusion:

Facility inspections are an integral part of the FDA certification process, especially for high-risk devices (Class III) or when concerns about quality or safety arise. Inspections are conducted to ensure that manufacturers comply with FDA regulations, including Good Manufacturing Practices (GMP) or Quality System Regulations (QSR). However, for low-risk devices, such as those classified under Class I, facility inspections may not always be necessary, though they can still occur if deemed appropriate by the FDA.

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