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Global Compliance News

FDA Looks for Real-World Performance Data on AI-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) is seeking public comment on how best to evaluate the performance of artificial intelligence (AI) technologies integrated within medical devices.

FCC Heralds Initial Success of “Operation Clean Carts”

The U.S. Federal Communications Commission (FCC) has made additional progress in its efforts to prohibit the sale or marketing of certain electronic equipment and devices made in China.

Study Shows Extended FDA Clearance Time for Medical Devices

FDA device clearance times remain lengthy—averaging 140–175 days, far beyond the 90-day goal. Staffing cuts and process shifts fuel delays, while underused third-party review programs offer a potential shortcut for manufacturers seeking faster approvals.

FCC Expands Deauthorization of State-Linked Testing Laboratories

The U.S. Federal Communications Commission (FCC) has continued its regulatory action regarding testing laboratories with foreign government ties.

FCC Launches “Operation Clean Carts” Initiative

The U.S. Federal Communications Commission (FCC) is touting its early success in removing from the market certain equipment deemed to be a “significant national security threat to communications networks.”
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FCC Looks to Accelerate Wireless Infrastructure Buildout

The U.S. Federal Communications Commission (FCC) is actively exploring ways to expand the wireless infrastructure in the U.S.

FDA Rescinds Rule that Applied Med Device Rules to Lab-Developed Tests

The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.

FCC and T-Mobile Enter Consent Decree Regarding the Marketing of Non-Compliant Devices

The Enforcement Bureau of the U.S. Federal Communications Commission (FCC) has reached an agreement with T-Mobile US to resolve claims regarding the company’s reported violation of the Commission’s Equipment Marketing Rules.

FCC Begins Process to Withdraw Recognition from Test Laboratories

The FCC is moving to withdraw recognition from seven test laboratories in a sweeping enforcement action. This unprecedented step, stemming from new rules adopted in May 2025, marks a significant shift in how the Commission oversees its certification and compliance testing infrastructure.

FCC Imposes Nearly $1 Million Fine Against Pirate Radio Operator

The FCC imposed a nearly $1 million fine on a New Jersey operator for running an unlicensed radio station. The penalty highlights the Commission's aggressive crackdown on pirate broadcasting operations.
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