Federal RuleAug 21
62
DOL Rewrites Disability Rules for 'Merit-Based Opportunity' Push
RuleLabor DepartmentFederal Contract Compliance Programs OfficeSignificant Wallet
119-hr-1539119th CongressWALLET
Medical Device Electronic Labeling Act
Sponsored By: Representative Obernolte, Jay [R-CA-23]
Introduced
Summary
Allows medical device labeling to be provided electronically instead of only on paper. The bill would let manufacturers post required device labeling online if the information is easy for intended users to access and paper copies are provided on request at no cost.
Show full summary
- Manufacturers: Would be permitted to supply required labeling electronically for most devices, including in vitro diagnostic devices, but must give users a free paper copy if requested.
- Patients and clinicians: Intended users must be able to readily access electronic labeling and can get a prompt paper version at no extra charge.
- Federal regulators: The Secretary of Health and Human Services could issue orders adding requirements or exemptions for devices with electronic labeling. Any such order must be published in the Federal Register after a proposed order and public comment, and may require label content only to reasonably assure device safety and effectiveness.
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Electronic medical device labels, free paper
If enacted, manufacturers could provide required labels for medical devices, including in vitro diagnostic devices, only online. Electronic labels would need to be easy for intended users to find. You could request a paper copy and get it quickly at no cost. The device or its container would still need a physical label with required information. The Secretary could add or waive label rules for certain device types after a proposed order and public comments, when needed for safety and effectiveness.
Sponsors & CoSponsors
Sponsor
Obernolte, Jay [R-CA-23]
CA • R
Cosponsors
Rep. Mullin, Kevin [D-CA-15]
CA • D
Sponsored 2/24/2025
Rep. Crenshaw, Dan [R-TX-2]
TX • R
Sponsored 2/24/2025
Rep. Craig, Angie [D-MN-2]
MN • D
Sponsored 2/24/2025
Rep. Peters, Scott H. [D-CA-50]
CA • D
Sponsored 4/8/2025
Rep. Miller-Meeks, Mariannette [R-IA-1]
IA • R
Sponsored 4/28/2025
Rep. Bilirakis, Gus M. [R-FL-12]
FL • R
Sponsored 5/6/2025
Rep. Gottheimer, Josh [D-NJ-5]
NJ • D
Sponsored 3/24/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov