Congress is considering several bills that may affect companies in the life sciences, particularly in connection with medical devices and in vitro diagnostics. One bill that is in play in the Senate would allow device manufacturers to electronically update device instructions without the need to replace physical labels, a proposal that has the backing of the Advanced Medical Technology Association (AdvaMed).
Sens. Jim Banks (R-Ind.) and John Hickenlooper (D-Colo.) announced the Medical Device Electronic Labeling Act May 13 in a press release stating that electronic instructions are already within the scope of the law. However, Hickenlooper and Banks stated that electronic instructions are legal only when the device is used in a healthcare facility or is expressly labeled for use by a healthcare professional. The Medical Device Electronic Labeling Act of 2026 (S. 4519) recognizes that users of all types are more reliant than ever on information provided online and that online sources can offer a more comprehensive overview of the product than can be had by paper copies of information.
In their May 13 statement, Hickenlooper and Banks emphasized the practical benefits of lowering the restrictions on electronic labeling updates. Banks said the proposed change to Section 502(f) of the Food, Drug and Cosmetic Act “just makes sense,” particularly given that S. 4519 stipulates that the manufacturer provide hardcopies on request. Hickenlooper said patients and users deserve to have rapid access to labeling and other information in electronic form rather than being forced to “sift through” paper-based information.
S. 4519 is in process in the Senate Health, Education, Labor and Pensions Committee, while a companion bill was introduced in the House of Representatives in 2025. Rep. Jay Obernolte (R-Calif.) introduced H.R. 1539 to the House Energy and Commerce Committee in February 2025.
AdvaMed President/CEO Scott Whitaker said AdvaMed supports the two bills in a May 14 press release thanking Banks and Hickenlooper for bringing S. 4519 into committee. Whitaker stated that electronic instructions provide a level of convenience that paper versions cannot match, adding that updates to electronic instructions can reach users much more rapidly than paper versions.
Whitaker said the efficiencies offered by these two bills “would help doctors and patients use medtech as efficiently as possible, achieving the full intended benefit of each innovation.” He said the fact that a version of the bill is in both chambers suggests that “there’s no reason we can’t get them passed and signed into law this year.”
Another bill that has drawn the support of medical device manufacturers is the Enhancing Clinical Laboratory Innovation and Access Act (Enhancing CLIA Act) of 2026. Rep. Neal Dunn (R-Fla.) announced the bill in a May 18, 2026, statement that emphasized the bill’s increased oversight of lab-developed tests (LDTs).
The FDA’s final rule for regulation of LDTs was rejected in litigation in March 2025 after a judge ruled that the agency lacked the statutory authority to oversee LDTs. Dunn said the legislation would codify clear lines of regulatory authority for these tests and would require that test developers publish performance and validation data for their tests.
The Enhancing CLIA Act would build on the Clinical Laboratory Improvement Amendments of 1988 in other ways, such as by establishing a centralized reporting system to track test performance. The bill is in process in the House Energy and Commerce Committee as well as the House Ways and Means Committee, and Dunn said the bill would restore confidence in LDTs without imposing costly and burdensome regulatory requirements that impede patient access.