Electronic Product Radiation Control (EPRC) Variance Application Process| FDA | FDA

Electronic Product Radiation Control (EPRC) Variance Application Process| FDA | FDA

FDA Simplifies Submission of Electronic Product Radiation Control Variance Requests

On September 1, 2020, the U.S. Food and Drug Administration (FDA) updated the Electronic Product Radiation Control (EPRC) variance requests process. This update is intended to provide manufacturers of devices and radiological health products with a simplified application process. The updates include:

• revised application instructions,
• updated variance forms,
• an optional CDRH variance package cover sheet (which includes a submission checklist) to help standardize and streamline the variance application and FDA review process.

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Questions?

If you have questions about variance requests, contact the Division of Industry and Consumer Education.