⚙️FDA Technical Amendments on Radiological Health Regulations
Radiological Health Regulations; Technical Amendments
Summary
The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines technical amendments to FDA regulations affecting manufacturers of radiation emitting electronic devices. Business owners must ensure compliance with the restored variance application requirements in § 1010.4 to avoid regulatory penalties. The changes could also impact operational processes for companies dealing with these products.