Press Releases

AdvaMed Applauds D.C. Circuit Decision Restoring Judicial Oversight to Rulemaking that Impacts Patient Care

Court’s Ruling Enhances Patient Safety by Ensuring Regulatory Oversight and Accountability in Medical Device Rulemaking

WASHINGTON – Today, AdvaMed, the Medtech Association, commended the U.S. Court of Appeals for the District of Columbia Circuit’s decision in the case Medical Imaging & Technology Alliance and Advanced Medical Technology Association v. Library of Congress and Carla Hayden (Case No. 23-5067), which ruled favorably in AdvaMed’s lawsuit to prevent unauthorized and unregulated repair companies from hacking into life-saving medical devices.

The court’s decision restores accountability to rulemaking under the Digital Millennium Copyright Act (DMCA) and affirms that the Library of Congress is subject to the Administrative Procedure Act (APA) when engaged in rulemaking under the DMCA. This ruling recognizes that the ability of federal courts to review federal rules is a fundamental component of the checks and balances system established by the Constitution.

“This decision is a significant victory for the medical technology industry and the principles of good governance,” said Christopher White, chief policy officer and general counsel of AdvaMed. “The ruling ensures that regulatory actions affecting our industry are subject to judicial review, thereby protecting the innovation and safety standards that are critical to our mission of advancing medical technology for better patient outcomes.”

AdvaMed brought this suit to challenge a DMCA rule that allows unregulated repair companies to hack into life-saving medical devices. In March of 2023, the D.C. District Court held that our claims were barred by sovereign immunity because the APA does not authorize lawsuits against Congress, and the Librarian of Congress is a part of Congress. AdvaMed argued that the Library of Congress, while conducting executive rulemaking functions, must be considered an agency subject to the APA. The D.C. Circuit’s decision validates this argument, ensuring that the Library’s rulemakings are not exempt from the procedural safeguards and judicial oversight established by the APA.

AdvaMed looks forward to a decision on remand that vacates the rule to resolve this important public health matter and protect the integrity of complex FDA-regulated medical devices.