As Schwartz reiterated in her letter, the FDA will continue to engage with stakeholders and evaluate its approach relating to cybersecurity and medical device servicing.
“The support of the FDA for continuation of this exemption cannot be overstated,' said Diana Upton, IAMERS president, stressing the significance of the letter.
Indeed, the letter offers important context for the FDA's position: “The ability to conduct maintenance and repair of devices to restore them or ensure they work in accordance with their original specifications and any changes to those specifications authorized for such devices or systems is critical to the continued safe and effective use of devices postmarket.”
While the FDA refers the Copyright Office to the FDA Guidance on "Remanufacturing of Medical Devices" for additional recommendations on activities that it considers to be servicing, its conclusion is, no doubt, valuable input to the process of renewing the repair exemption.
In light of the U.S. Court of Appeals June 7, 2024 decision
reversing the U.S. District Court denial of challenges to the Librarian of Congress’ granting of an exemption, the FDA’s letter of support for renewal of the exemption may appear contradictory, but this would be comparing proverbial apples to oranges.
In the U.S. Court of Appeals decision, the court determined that the copyright rules promulgated under the DMCA are reviewable under the U.S. Administrative Procedures Act. Concluding that the Copyright Regulations are reviewable just like other copyright rules, the Court sent the matter back to the U.S. District Court for review under the APA. This did not decide the issue of the propriety of the repair exemption or deny the Librarian the right to decide the exemption. Rather, the Court of Appeals returned the matter to the U.S. District Court for APA analysis.
Support well exists for continuation of the medical device exemption, and the FDA’s most recent letter is consistent with renewal. So... stay tuned.
About the author: Robert J. Kerwin is the general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.Back to HCB News
