guidance

FDA Issues Draft Guidance on AI-Based Medical Devices

The FDA releases landmark draft guidance for AI-enabled medical devices, offering manufacturers a roadmap for development, approval, and lifecycle management while addressing critical concerns of transparency and demographic bias.

FCC Adopts Guidance on Orbital Space Debris

The FCC has recently published new guidance to provide further clarification around the requirements that apply to space satellite operators under the agency's existing orbital debris mitigation rules.

FDA Issues Updated Guidance on Medical Device UDI Requirements

The U.S. Food and Drug Administration (FDA) has released an updated Guidance on the...

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain...

FDA Sets Policy for Device Functions of Mobile Medical Apps

In an effort to keep pace with its oversight of advanced medical devices and...

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FDA Releases Guidances on Benefit-Risk Determinations for Medical Devices

The U.S. Food and Drug Administration (FDA) has published two final guidance documents related...

FDA Releases Guidance on Diagnostic Ultrasound Systems

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

U.S. FDA Issues Guidance on Medical Devices Containing Materials of Animal Origin

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug...

FDA Issues Updated Guidance on Addressing Medical Device Changes

In an effort to reduce confusion among manufacturers whose medical devices are subject to...

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EU Sets Plan to Become Global Leader in AI Technology

High Intensity Radiated Fields (HIRF), Part 4

FCC Issues Limited Delay in TCPA Implementation

Efforts Underway to Save Marconi Radio Towers in Canada

FDA Struggles to Meet Product Review Deadlines

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