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The U.S. Food and Drug Administration (FDA) has now rescinded 2024 rules that required laboratory-developed tests (LTDs) to comply with the agency’s pre-marketing authorization requirements applicable to medical devices.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

FDA Updates Authorizations List for Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) has recently updated its list of medical devices that have received market authorization under its Breakthrough Devices Program.

FCC Proposes Updated Standards for Equipment Authorization

The U.S. Federal Communications Commission (FCC) has proposed updates to its rules to reflect...

Changes to the FCC’s Authorization and Importation Rules Now in Effect

The FCC updated its equipment authorization procedures and rules in a number of significant ways.
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