H.R.1539 - Medical Device Electronic Labeling Act (119th Congress)
Summary
H.R.1539, the Medical Device Electronic Labeling Act, aims to amend the Federal Food, Drug, and Cosmetic Act to allow medical device labeling to be provided solely through electronic means. This applies to a broader range of devices than currently permitted. The bill ensures that users can still request and receive the labeling in paper form at no additional cost.
Expected Effects
The bill would reduce manufacturing costs for medical device companies by decreasing the need for printed labels. It also allows for more easily updated labeling information. The FDA retains the power to mandate specific labeling requirements for certain devices, even when electronic labeling is used.
Potential Benefits
- Reduced costs for medical device manufacturers, potentially leading to lower prices for consumers.
- More readily accessible and up-to-date labeling information for healthcare professionals and patients.
- Environmentally friendly by reducing paper consumption.
- Streamlined regulatory processes for medical device labeling.
- Increased efficiency in disseminating important safety information.
Potential Disadvantages
- Potential accessibility issues for individuals without reliable internet access or digital literacy.
- Risk of overlooking critical safety information if users do not actively seek out electronic labels.
- Possible increased burden on users to request and manage paper copies of labels.
- Dependence on technology, which could be problematic in emergency situations or areas with power outages.
- The need for robust cybersecurity measures to protect electronic labeling from tampering or unauthorized modification.
Constitutional Alignment
This bill appears to align with the Commerce Clause (Article I, Section 8, Clause 3) of the U.S. Constitution, as it regulates interstate commerce related to medical devices. The bill also includes provisions for public comment and due process in the establishment of labeling requirements, aligning with general principles of administrative law and fairness. The bill does not appear to infringe upon any specific individual rights or freedoms protected by the Bill of Rights.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).