Medical device makers can ditch printed labels—if you have internet.

What it does

This bill amends federal law to allow manufacturers of medical devices to provide required labeling information solely through electronic means (websites, apps, digital documents) rather than printing it on the device or its packaging, provided the information is readily accessible, users can request paper copies at no cost, and the physical label still includes all legally required information. The FDA retains authority to set additional requirements or exceptions for specific device types if safety demands it.

Why we flagged it

The bill's core function is to modernize labeling compliance by permitting digital-only distribution of required information for medical devices, reducing manufacturer burden while preserving user access rights and FDA oversight. This is a regulatory efficiency measure, not a deregulation or carve-out.

What the text implies

• Electronic-only labeling may disadvantage elderly, rural, or low-income users without reliable internet access or digital devices, creating a disparate-impact risk not addressed in the bill.
• The bill requires manufacturers to provide paper copies 'upon request' but does not specify enforcement mechanisms, timelines, or penalties for non-compliance, potentially weakening the paper-access safeguard.
• FDA's authority to issue orders establishing additional requirements is preserved, but the bill does not require the FDA to proactively assess which device types pose safety risks if labeling is electronic-only.
• The phrase 'readily accessible' is undefined in the bill and will depend on FDA regulation; manufacturers may interpret this permissively, creating a gap between legislative intent and practical access.

Section numbers refer to the bill text the analysis read — linked under Primary records below.

Who it affects

Citizens gain convenience (digital labeling is often more accessible and updatable than static print) and manufacturers' cost savings may lower device prices, but the shift to electronic-only labeling creates a digital-access barrier for users without internet, smartphones, or digital literacy, and relies on manufacturer compliance with accessibility and paper-request provisions that lack explicit enforcement mechanisms in the bill text.

Who stands to gain

• medical device manufacturers (reduced printing and packaging costs)
• in vitro diagnostic device manufacturers (same cost savings)

Named in the bill

FDA (Food and Drug Administration), medical device manufacturers, in vitro diagnostic device manufacturers, Federal Food, Drug, and Cosmetic Act, Section 502(f)

Where it stands

7 cosponsors: 4 Democrats, 3 Republicans.

• Feb 24, 2025 — Introduced · Congress.gov: “Introduced in House”
• Feb 24, 2025 — Referred to House Committee on Energy and Commerce · Congress.gov: “Referred to the House Committee on Energy and Commerce”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

7 lobbying clients named this bill on 8 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $5,683,000 in lobbying spend. A filing names 9 bills on average, so that figure is what each filing reported, not a share belonging to this bill.

More lobbying clients named this bill than 86% of bills with at least one filing.

Jay Obernolte, the sponsor, reported $976,024 in PAC receipts in the 2026 cycle. $9,500 of that came from 3 PACs tied to these lobbying clients.

• Advanced Medical Technology Assn — $1,913,000 on 2 filings
• Johnson & Johnson Services Inc — $1,440,000 on 1 filing
• Medtronic Inc — $1,180,000 on 1 filing
• Philips Holding USA Inc. — $640,000 on 1 filing
• Dexcom, Inc. — $370,000 on 1 filing

Lobbying Disclosure Act filings through Jul 21, 2026. A filing shows who paid to lobby on a bill it names, not what changed.