guidance

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...

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...

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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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Product Insights: The Sources of Uncertainty in Radiated Emissions Tests

FDA Issues Pilot Program to Enhance Medical Device Recalls

FCC Issues Final Rules for Program-Originating FM Boosters

Practical Engineering: Odds and Ends – Navigating the Nuances of Compliance Engineering

FDA Issues Guidance on Third-Party Review Program

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