1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

FDA Issues Final Guidance For Radiological Devices Using Quantitative Imaging

Document updates agency’s 2019 guidance

 
• By Brian Bossetta

The US FDA has published its final guidance for premarket submissions of radiological devices that use quantitative imaging – technology which offers clinicians a more accurate picture of a disease.

Doctor Scanning MRIs
• Source: Shutterstock

After publishing an initial guidance on the topic three years ago, the Food and Drug Administration has issued its final guidance for manufacturers submitting radiological devices that use quantitative imaging for premarket review.

The document, “Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submission,” posted on 16 June, clarifies that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

Malaysia’s MDA At Asia Forum: ‘Regulatory Silos Are Not The Way Forward Anymore’

 
• By Ashley Yeo

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

EU Data Act Applies From Today: But Medtech Wants Delay

 
• By Amanda Maxwell

The unwieldy application demands of the EU’s bunch of interconnected data regulations are creating headaches for the medtech industry.

Unified Agenda Rescinds LDT Rule, Sets Few New Priorities

 
• By Elizabeth Orr

The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.

More from Policy & Regulation

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown

 
• By Brian Bossetta

The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.