This final rule will help ensure the requirements for radiation emitting electronic products and medical devices continue to protect the public health and safety while reducing unnecessary regulatory burdens

Getty Images


February 22, 2023 — In January 2023, the U.S. Food and Drug Administration (FDA) published the final rule: 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

This rule went into effect Feb. 21. This final rule will help ensure the requirements for radiation emitting electronic products and medical devices continue to protect the public health and safety while reducing unnecessary regulatory burdens. 

The Final Rule: 

  • Removes recommendations in the regulations that have become outdated or duplicative to more current recommendations by the FDA, industry, and professional societies. 
  • Amends and repeals certain records and reporting requirements for electronic products, including reporting for diagnostic X-ray systems and lasers that are unnecessary or duplicative of other reporting requirements by the FDA. 
  • Amends the reporting requirements for manufacturers that incorporate a certified Class I, II, or IIIa laser product to the reduce reporting that is considered duplicative under certain conditions. 

You can read the published final rule here.  


Related Content

Videos | Breast Imaging

Don't miss ITN's latest "One on One" video interview with AAWR Past President and American College of Radiology (ACR) ...

Time April 11, 2024
arrow
News | Society of Breast Imaging (SBI)

April 11, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, announced today ...

Time April 11, 2024
arrow
News | Cybersecurity

April 10, 2024 — The American Medical Association (AMA) released informal survey findings (PDF) showing the ongoing ...

Time April 10, 2024
arrow
News | Breast Imaging

April 8, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, is proud to ...

Time April 08, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 5, 2024 — Osteoarthritis — not age — may play the greatest role in determining the utility of MRI for patients 45 ...

Time April 05, 2024
arrow
News | Ultrasound Imaging

April 5, 2024 — EchoNous, a leading innovator in ultrasound technology, announced the upcoming Kosmos 2.2 release on ...

Time April 05, 2024
arrow
Feature | Radiology Business | By Melinda Taschetta-Millane

Here is a snapshot of the Top 10 most-read content from ITN's viewers during the month of March: 1. Philips Teams with ...

Time April 04, 2024
arrow
News | Mammography

April 3, 2024 — Densitas, a global leader in artificial intelligence solutions for breast cancer screening, announces ...

Time April 03, 2024
arrow
News | Radiology Business

April 2, 2024 — Less than three months after signing an agreement to acquire MIM Software Inc., GE HealthCare ...

Time April 02, 2024
arrow
News | Breast Imaging

April 2, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, announced ...

Time April 02, 2024
arrow
Subscribe Now