Rulemaking on Medical Device Exemption Now Rightly Under Review
The Safe to Repair Project aims to ensure that individuals who service or repair medical technology used for treatment or diagnosis are qualified and adhere to FDA guidelines.
This month, the U.S. Court of Appeals effectively ruled that an important decision from the Library of Congress back in 2020 that facilitates businesses right to repair on medical devices needs more consideration.
Back in 2023, two organizations contested a decision by the Librarian of Congress to allow exceptions to the Digital Millennium Copyright Act (DMCA) rules for medical devices. This essentially would allow unauthorized repairmen and servicers to bypass copyright laws for medical devices. But the U.S. District Court dismissed their challenge.
The new decision by the Court of Appeals is a positive development for those who believe that patient safety should come before policies influenced by ideology. The case will now go back to the U.S. District Court for a more thorough review under the guidelines of the U.S. Administrative Procedures Act (APA), ensuring that the original decision is carefully reconsidered.
The Librarian is authorized by Congress to identify every three years classes of copyrighted works to which the DMCA anti-circumvention provision won’t apply. In 2020, the Librarian was petitioned by third party servicers to include medical device manuals among their exemptions. The request was granted and has since been renewed.
Incorrectly repaired equipment can pose significant risks to patient health and safety, especially during critical procedures. Originally dismissed in March 2023, MITA and AdvaMed’s challenge argued that the Librarian’s decision makes them an “agency” and therefore reviewable under the APA.
This is welcome news and gives companies who are interested limiting exposure to themselves and their patients a chance to challenge the exemption under the DMCA in court. Independent servicers are neither regulated nor monitored, and not required to adhere to the FDA’s Quality System Regulations or report adverse repair events. We have strong federal regulations on the manufacturers in this market, but none related to third-party services. This gap puts patients at serious risk.
Last year, the American Consumer Institute (ACI) submitted a comment detailing why the exemption should not be renewed, emphasizing that temporary exemptions for medical devices from right-to-repair provisions could “jeopardize patient safety.” ACI emphasized that medical devices are highly specialized and complex pieces of equipment requiring precise maintenance and repair protocols. Unauthorized access to repair manuals increases the risk of incorrect repairs, potentially leading to device malfunctions during critical procedures.