H.R.1539 amends 21 U.S.C. 352(f) to permit manufacturers to make required labeling for medical devices, including in vitro diagnostics, available solely by electronic means if the labeling is “readily accessible,” the manufacturer will provide a paper copy upon request at no cost, and the device’s affixed label meets statutory or FDA-ordered content requirements. The bill also gives the Secretary of Health and Human Services (FDA) authority to issue device-type-specific orders that create additional requirements or carve-outs for what must appear on the physical label.
This change reduces the need for printed manuals and allows faster labeling updates, but it also places new compliance and access obligations on manufacturers, creates potential gaps for users without reliable internet access, and concentrates discretion at FDA to set where and how e-labeling can be used safely. The bill frames those trade-offs through device-specific FDA orders and a public-comment process for issuing them.
At a Glance
What It Does
The bill allows required labeling for devices (including IVDs) to be provided only electronically if the labeling is readily accessible and manufacturers will furnish a paper copy promptly and free upon request. It conditions electronic-only labeling on the content of the physical label and gives FDA authority to issue orders that add exceptions or requirements for particular device types.
Who It Affects
Device manufacturers and their distributors, laboratories and clinical sites that use in vitro diagnostics, healthcare providers that rely on labeling at point of care, and FDA as the agency that will define which devices may use e-labeling and what must remain on a physical label.
Why It Matters
The bill modernizes labeling practices and enables quicker amendments to instructions and warnings, but it shifts operational burdens (digital publishing, paper-request systems) onto industry and concentrates substantive judgment at FDA about what information must remain physically affixed to devices to protect patients.
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What This Bill Actually Does
The bill rewrites the statutory provision that governs labeling for drugs and devices to explicitly permit device labeling to exist only in electronic form, but it wraps that permission in three concrete constraints. First, the electronic labeling must be "readily accessible" to the intended users — a standard the bill does not define but that will be central to compliance.
Second, manufacturers must give users the opportunity to request a paper copy and must provide that copy promptly and at no charge. Third, the label attached to the device or its immediate container still must comply with the Act and applicable regulations or with whatever FDA order applies to that device type.
Crucially, the bill gives the Secretary (FDA) explicit authority to issue orders that tailor these requirements — adding requirements for the physical label or permitting exceptions for specific device types. The process for those orders requires publication of a proposed order, a public docket for comments, and final publication in the Federal Register; the bill carves this process out from the ordinary Administrative Procedure Act subsection referenced but preserves an opportunity for public comment in the Federal Register.The Secretary’s authority is bounded: FDA can require specific content on an affixed label only if it determines the content is necessary to provide a reasonable assurance of safety and effectiveness.
That creates a legal threshold tying physical-label mandates to safety determinations, which will matter when FDA decides whether a device’s critical warnings or usage instructions can be delivered solely via digital channels.Operationally, manufacturers must build and maintain systems to host and serve labeling files, demonstrate that users can access them, and process free, prompt paper requests. For distributed products and international manufacturers, supply-chain labeling practices may need revision.
For FDA, the bill creates a device-by-device regulatory pathway to allow or restrict e-labeling and imposes a public-comment step for those decisions, which will shape how quickly and broadly e-labeling is adopted across device classes.
The Five Things You Need to Know
Manufacturers may deliver required device labeling solely by electronic means only if the labeling is “readily accessible” to intended users and the manufacturer provides a paper copy promptly and without charge upon request.
The statute expressly includes in vitro diagnostic devices (IVDs) in the scope of devices eligible for electronic-only labeling.
A physical label must comply with the Act and regulations or with any applicable FDA order — meaning FDA orders will determine what may be omitted from an affixed label for a given device type.
FDA may issue device-type-specific orders setting additional requirements or exceptions for affixed labels after publishing a proposed order and considering public comments; the bill modifies but does not eliminate notice and comment.
FDA can require that certain information remain on an affixed label only if it determines that requirement is necessary to provide a reasonable assurance of the device’s safety and effectiveness.
Section-by-Section Breakdown
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Short title
Designates the act as the “Medical Device Electronic Labeling Act.” This is purely stylistic but signals the bill’s central purpose: to modernize how required labeling for medical devices is delivered.
Permits required labeling to be made available solely electronically (with conditions)
Adds a new paragraph allowing required labeling for devices, including IVDs, to be available solely by electronic means provided three conditions are met: the electronic labeling is readily accessible to intended users; manufacturers offer and promptly provide free paper copies upon request; and the physical label affixed to the device or immediate container complies with the Act, regulations, or any applicable FDA order. Practically, this creates a baseline entitlement to e-labeling but ties its usability to access and paper-backup guarantees.
Gives FDA authority to set device-specific label exceptions or additional requirements
Authorizes the Secretary to issue orders for particular device types that either add to or carve out from the electronic-labeling conditions in (2). The provision requires FDA to publish a proposed order in the Federal Register, host a public docket for comments, and then publish the final order, while expressly noting the process is handled notwithstanding the cited APA subchapter. The Secretary may impose affixed-label requirements only if necessary to assure safety and effectiveness; this ties substantive decisions about what must remain physical to FDA’s safety determinations.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Large device manufacturers — reduce recurring printing and distribution costs and can push labeling updates faster (postmarket changes, software updates, corrections) by updating online materials instead of reprinting manuals.
- Clinical laboratories and hospital systems with integrated digital information systems — gain easier access to the latest instructions, including IVD performance data and updates, via centralized electronic sources.
- FDA — obtains a calibrated tool to permit e-labeling device-by-device and to require only the minimal physical labeling necessary to protect safety, potentially improving regulatory flexibility.
Who Bears the Cost
- Smaller manufacturers and startups — must develop and maintain electronic hosting, accessibility verification, and consumer-request fulfillment systems, which may be disproportionately costly compared with printing existing labels.
- Patients and caregivers without reliable internet access, limited digital literacy, or whose point-of-care environments lack connectivity — risk reduced access to critical warnings and instructions unless paper-request processes are robust and timely.
- State and federal inspectors and compliance staff at FDA — face new enforcement, inspection, and audit tasks to verify electronic availability, prompt paper fulfillment, and that device labels posted electronically match regulatory requirements.
Key Issues
The Core Tension
The central dilemma is between efficiency and equity: the bill reduces printing burdens and enables faster, centralized labeling updates, which benefits manufacturers and digitally equipped providers, but it risks degrading immediate, universal access to safety-critical information for users without reliable digital access — a trade-off the bill resolves by pushing the hard choices to FDA to decide, device by device.
The bill creates a practical paradox: it authorizes electronic-only labeling but simultaneously requires that the physical label comply with the Act and regulations or an applicable FDA order. That means e-labeling will be feasible only when FDA uses its new order authority to permit exceptions for what must appear on a physical label.
The order process the bill prescribes keeps a public-comment element but changes the APA cross-reference, which may prompt litigation over the procedural adequacy of FDA actions and slow adoption as stakeholders test the new pathway.
The statute leaves key compliance terms undefined. "Readily accessible" is central to whether a digital label meets the statutory test, but the bill does not define the standard or the metrics FDA should use (e.g., uptime, mobile-optimized pages, language access, file formats, embedding in device software). Similarly, "promptly" for paper fulfillment has no deadline, which creates uncertainty about acceptable response times and logistics.
Those gaps shift interpretive burden to FDA rulemaking or enforcement guidance and raise the prospect of uneven implementation across device classes and manufacturers.
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