As expected, the U.S. Federal Communications Commission (FCC) has approved new rules that it says will support the integrity and security of electronic device testing laboratories and services.

The Commission voted to enact a rulemaking detailed in a draft Second Report and Order and Second Further Notice of Proposed Rulemaking that will ban recognition of testing labs, testing certification bodies, and laboratory accreditation bodies located in or operating within countries that do not have a Mutual Recognition Agreement (MRA) or reciprocal trade agreement in effect with the U.S.

Specifically, the new rules will:

• Require all test labs and telecommunications certification bodies (TCBs) to provide the Commission with the names of all foreign employees involved in testing and certification activities;
• Update post-market surveillance and enforcement procedures and establish confidential communications channels to report potential violations or national security concerns;
• Develop a consolidated list of prohibited testing labs to facilitate more efficient applicant screening; and
• Provide an expedited review process for devices tested by “Trusted Test Labs,” that is, labs based in the U.S. or in a country with an MRA or comparable trade agreement in effect.

The new regulations detailed in the Second Report and Order will take effect as of June 1, 2026.

The U.S. Food and Drug Administration (FDA) has announced a new initiative to help provide patients with new and innovative medical technologies that can be used in home settings.

According to the FDA, the new initiative, titled “READI-Home: Reducing Readmissions through Device Innovation for the Home,” invites medical device companies and developers to participate in an innovation challenge, in which they provide proposed solutions for medical device technologies to be used in the home setting.

Applicants will be reviewed by the agency during the Selection Phase, with a limited number selected to proceed to the Interaction Phase. During the Interaction Phase, selected participants will benefit from early engagement with FDA regulatory officials and receive regular feedback so that they can further refine their designs.

The READI-Home initiative is part of the FDA’s Center for Device and Radiological Health’s (CDRH) “Home as a Healthcare Hub Initiative.”

The European Association of Medical Devices Notified Body (Team-NB) is concerned that certain proposed changes in the upcoming revisions of the EU’s Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) could compromise patient safety.

According to an article posted to the website of the Regulatory Affairs Professional Society (RAPS), Team‑NB shared its concerns with the European Commission in early April about specific changes in the proposed revisions intended to reduce the potential for medical device shortages throughout the EU.

Specifically, “the proposed measures jointly reduce notified body involvement across certification and surveillance activities,” including less surveillance, less sampling, less in‑depth reviews, less review of clinical information at various stages, and less unannounced audits.

According to Team-NB Director Francoise Schlemmer, “viewed cumulatively, these changes would lower regulatory oversight to a level below that applied under the Directives…shifting the EU systems from a preventative to a predominantly reactive model.”