Medical Innovation Acceleration Act of 2023 This bill exempts noninvasive diagnostic devices from the regulatory authority of the Food and Drug Administration. The bill defines noninvasive diagnostic device as one that does not penetrate the skin or any other membrane of the body, is not inserted or implanted into the body, causes no more than ephemeral compression or temperature changes to in situ bodily tissues, and does not subject bodily tissues to ionizing radiation.
Facilitating Innovative Nuclear Diagnostics Act of 2023
Facilitating Innovative Nuclear Diagnostics Act of 2023
Informing Consumers about Smart Devices Act This bill requires manufacturers of internet-connected devices (e.g., smart appliances) that are equipped with a camera or microphone to disclose to consumers prior to purchase that a camera or microphone is part of the device. The bill does not apply to mobile phones, laptops, or other devices that a consumer would reasonably expect to include a camera or microphone.
To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring the manufacturers of a covered device to disclose to a patient all patient-specific data that is recorded or transmitted by the device and accessible to the manufacturer, and for other purposes.
Accelerating a Circular Economy for Plastics and Recycling Innovation Act of 2024
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs within its first 12 years of U.S. sales of the drug. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
Support And Value Expectant Moms and Babies Act of 2023 or the SAVE Moms and Babies Act of 2023 This bill prohibits the Food and Drug Administration (FDA) from approving any new drug (either as a brand-name drug or a generic) intended to terminate a pregnancy and imposes additional restrictions on such drugs that are already approved. Under the bill, an already-approved drug intended to terminate a pregnancy may be dispensed to a patient only with a prescription. Furthermore, the FDA may not approve any labeling change that would authorize (1) using the drug after 70 days of gestation, or (2) dispensing the drug by any means other than in-person administration by the prescribing health care practitioner. The FDA must also impose additional restrictions on such already-approved drugs, including by (1) requiring the prescribing health care practitioner to receive a special certification, (2) prohibiting the practitioner from also acting as the dispensing pharmacist, and (3) requiring the practitioner to have the ability to provide surgical intervention to the patient. The bill also rescinds any investigational use exemption already granted to such a drug if the bill would have prohibited the FDA from granting the exemption. (Currently, the FDA may grant an exemption to certain market approval requirements if a drug is intended solely for use in safety and effectiveness investigations.)
Medical Device Nonvisual Accessibility Act of 2024
Protecting Life on College Campus Act of 2023 This bill prohibits the award of federal funds to an institution of higher education (IHE) that hosts or is affiliated with a school-based service site that provides abortion drugs or abortions to its students or to employees of the IHE or the site. An IHE that hosts or is affiliated with a site must, in order to remain eligible for federal funds, annually certify that the site does not provide abortion drugs or abortions to students or employees.