As previously covered on this blog and in our alert, the U.S. House of Representatives passed the 21st Century Cures Act (H.R. 6) in July 2015. The U.S. Senate Committee on Health, Education, Labor, and Pensions (commonly referred to as the “HELP Committee”) has worked on companion legislation to the House bill and, since February of this year, has held three executive sessions to consider a number of biomedical innovation bills. The proposals that have been considered and passed by the HELP Committee include the following bills related to the regulation of medical devices.
- The FDA Device Accountability Act of 2015 (S. 1622). This bill would require FDA to ensure that each agency employee who is involved in reviewing premarket submissions receives training on the least burdensome requirement and to assess periodically the implementation of those requirements.
- The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077). FDCA Section 515(d)(5) provides for priority review of PMAs for “breakthrough” devices. S. 1077 would expand this program to all device classes. The program would apply to devices that are breakthrough technologies, for which no approved alternatives exist, that offer significant advantages over existing approved or cleared alternatives, or the availability of which is in the best interest of patients. These criteria reflect the same standard for determining a PMA’s eligibility for priority review under section 515(d)(5).
- The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101). This bill would enact significant changes to FDA regulation of medical software and device accessories. This bill is one of several that has been introduced in the past few years related to the regulation of software products. This bill would exclude from the device definition several types of software, including software intended to encourage a healthy lifestyle, electronic patient records, and software that provides medical recommendations and the basis for those recommendations to health care professionals (excluding analysis of medical images or signals).
- The Combination Product Regulatory Fairness Act of 2015 (S. 1767). This bill would clarify FDA’s authority for reviewing combination product applications and provide more information to sponsors. S. 1767 would establish a process through which sponsors can submit a “Combination Product Review Plan” to FDA to obtain clarity and feedback from the agency regarding the development of a specific product and contains provisions that permit a combination product applicant to rely upon a prior finding of safety and effectiveness or substantial equivalence for an “approved constituent product” to support approval. In addition, if FDA disagrees with the views of a product sponsor, FDA would be required to provide the scientific rationale supporting a determination that a product is not a medical device before making that determination and provide the scientific rationale for deciding the primary mode of action of a combination product.
Senator Lamar Alexander, who serves as chairman of the HELP Committee, has indicated that some issues will be addressed on the Senate floor, including oversight for laboratory developed tests (LDTs), postmarket device surveillance, and regenerative medicine.
The Senate’s discussion of LDT oversight will be closely watched, particularly given FDA’s statements that it intends to begin regulating LDTs as medical devices. In a related development this week, the House Appropriations Committee passed by voice vote the Agriculture-FDA spending bill and included accompanying report language as follows: “The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.”