Interim Guidelines for the Conduct of Licensing Inspection for Radiation Facilities

The FDA has issued FDA Circular No. 2020-035, which pertains to Interim Guidelines for the Conduct of Licensing Inspection for Radiation Facilities. Under this Circular, any pending applications will be nullified, requiring new applications to be submitted. Below are the interim guidelines for the conduct of pre-licensing inspections of Health Physics teams of the CDRRHR of the FDA.

Note: This Circular shall take effect November 19th 2020

The following facilities applying use of radiation devices during COVID-19 measures:

• Diagnostic X-ray Facilities
• Therapeutic X-ray Facilities utilizing Medical Linear Accelerator
• Dental X-ray Facilities
• Industrial and Anti-Crime X-ray Facilities
• Education and Research X-ray Facilities
• Veterinary X-ray Facilities
• Transportable X-ray Facilities
• Magnetic Resonance Imaging Facilities

However, the FDA will resume pre-licensing inspections for Medical Linear Accelerators. This can be done either online or by virtual inspection. For other types of radiation facilities, authorization will be done using an interim radiation facility authorization process and will be verified with a post-licensing inspection when quarantine measures end.