As the U.S. Copyright Office conducts its triennial Section 1201 rulemaking proceeding on DMCA exemptions this year, the FDA has issued a letter supporting the proposed renewal of the DMCA Exemption Regarding Repair of Medical Devices and Systems.

On June 21, 2024, Suzanne Schwartz, director of the FDA Office of Strategic Partnerships and Technology Innovation, informed the Copyright Office that the FDA stands behind the proposed exemption from the Digital Millennium Copyright Act that would apply “to circumvention [of technological protections] that is conducted solely to obtain data access for the purpose of diagnosis, maintenance or repair of devices.”

The letter makes clear that the FDA would not support circumvention for the purpose of device modification, noting “…FDA’s view is that an exemption from liability under 17 U.S.C. §1201 for circumvention conducted solely for [repair] purposes would not necessarily and materially jeopardize the safety and effectiveness of medical devices in the United States with respect to cybersecurity.”

To better understand the significance of the FDA’s letter of support, it is important to have a little legislative context as to why the U.S. Copyright Office is conducting its rulemaking proceedings.

Section 1201 of the Digital Millennium Copyright Act provides that the Librarian of Congress, upon the recommendation of the Register of Copyrights, may adopt temporary exemptions to the Section 1201 prohibition against circumvention of technological measures that control access to copyrighted works. As the Copyright Office notes, “[t]he ultimate goal of the proceeding is to determine whether there are particular classes of works as to which users are or are likely to be in the next three years, adversely affected in their ability to make noninfringing uses due to the prohibition on circumventing access controls”. When these classes are identified, the Librarian of Congress may promulgate regulations exempting the classes from the prohibition for the following three years.

In this case, some opponents had argued that for cybersecurity reasons, renewal of the repair exemption was not appropriate. The FDA suggested otherwise and even included in its letter to the U.S. Copyright Office a copy of its 2021 letter of support, in which it stated that “FDA, therefore, does not share the view that an exemption from liability under 17 U.S.C. §1201 for circumvention conducted solely for the purpose of diagnosis, maintenance, or repair of medical devices would necessarily and materially jeopardize the safety and effectiveness of medical devices in the United States with respect to cybersecurity…”

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.

This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/63342