Legislation that would impact device regulations is flowing out of the Senate Health, Education, Labor, and Pensions (HELP) committee.

The panel held the last of three markups on its medical innovations project April 6, and devices have been an important focus of the committee during the past several months. (See Also see "Senate Moves To Floor Phase For Innovation Bill; Postmarket Surveillance, LDTs Could Get Attention" - Medtech Insight, 7 April, 2016..) The next step is for the bills approved by the HELP Committee to be combined, potentially with more amendments, into a companion package to the 21st Century Cures Act, which passed the House last July. (See [A#01151026018].)

Below is a chart listing the device-relevant bills that have passed through the HELP Committee aligned with similar House Cures' provisions. The House Cures' package includes several device sections that were not addressed during the HELP Committee markups, including a provision that would allow device-makers to make certain device modifications without FDA review if the firm's quality system is validated by a third party; reforms to the advisory committee process; and humanitarian device exemption program reforms. But individual bills addressing these and several other device provisions have been introduced previously in the Senate. (For example, see [A#01151026018].)

Senate Bill	HELP Committee Passage	Related House 21st Century Cures Provision	Comparison
The Advancing Breakthrough Devices Act, S. 1077	March 9	Priority Review for Breakthrough Devices (Sec. 2201)	Both House and Senate bills create accelerated development pathways for devices addressing unmet needs. The Senate version removes 510(k) devices from the program and would make it explicit that qualifying devices must target life-threatening or debilitating conditions.
The Device Accountability Act, S. 1622	Feb. 9	Streamlining Clinical Device Trials (Sec. 2262); Training, Oversight in the Least Burdensome Concept (Sec. 2223); *CLIA Waiver Study Design Guidance For In Vitro* Diagnostics** (Sec. 2228)	Senate bill directly mirrors three House provisions in that it would allow centralized Institutional Review Boards to oversee device trials; mandates FDA training for device reviewers to use the "least burdensome" methods to clear and approve medtech products; and would require FDA to rethink its standards for allowing diagnostic assays to be used in simpler lab environments under CLIA waivers.
The Combination Products Innovation Act, S. 1767	March 9	Combination Products Guidance (Sec. 2181)	Senate bill would streamline the combo products review process, including pushing FDA to not designate a combination product as having a drug primary mode of action without sufficient justification, and it would let FDA take into account prior findings of safety and effectiveness of combo products components. House Cures provision simply mandates issuance of FDA guidance describing the responsibilities of each agency center in the review of combination products.
The Preventing Superbugs and Protecting Patients Act, S. 2503	Feb. 9	No House Match	Senate bill, introduced by HELP ranking member Patty Murray, D-Wash., is aimed at preventing further contamination of reusable devices such as duodenoscopes. It presses FDA to clarify its policies for when a new 510(k) is needed for device modifications, and provides FDA with more authority to require validated reprocessing (cleaning and sterilization) data for reusable devices.
Improving Health Information Technology Act, S. 2511	Feb. 9	Interoperability (Sec. 3001)	Senate bill would set interoperability standards to make electronic health records coordinated enough for users to view results of patient tests, access data recorded by medical devices and use registry data to design clinical trials. Discourages "information blocking" between competitors. House bill requires that electronic health records vendors meet new interoperability standards. Firm has to certify interoperability with HHS; could not engage in "information blocking" from competitor vendors that would prevent information exchanges.
The MEDTECH Act, S. 1101	March 9	The SOFTWARE Act, (Secs. 2241, 2242, and 2243)	Very similar language between Senate and House bill. Establishes criteria for what health IT software – or "clinical decision software" – should or shouldn't be regulated by FDA.
The FDA and NIH Workforce Authorities Act, S. 2700 – with Roberts Amendment on legal justification for FDA guidances.	April 6	Improving Scientific Expertise at FDA, (Secs. 2281, 2283 and 2285) No House Match on Sen. Pat Roberts (R-Kan.) amendment.	The House provision Sec. 2281 parallels the Senate bill's to revise the Silvio O. Conte biomedical research service to remove the limits on numbers of members at NIH/FDA in this service, but the Senate would cap the number of members – who represent "top talent," says Sen. Lamar Alexander, R-Tenn. – at 2,000. Both bills have provisions to grant FDA additional hiring authority for scientific, technical or professional experts within certain centers. The Roberts amendment in the Senate bill calls on FDA to supply a legal justification for using a guidance, rather than formal rulemaking, to explain their policy on a topic each time the agency puts out a guidance. No parallel in the House "Cures" bill.
The Advancing Precision Medicine Act, S. 2713	April 6	FDA Advancement of Precision Medicine (Sec. 2041)	Senate bill would establish the necessary authorities at various agencies to carry out President Obama's Precision Medicine Initiative. Close match to House provision on Precision Medicine in Cures bill, which calls on FDA to define “precision” drugs and the evidence needed to support their use in a subset of patients. House version also asks FDA to expedite clinical development of precision drugs for the treatment of serious or rare conditions; says FDA may rely upon data previously submitted for a different approved drug or indication.
Advancing NIH Strategic Planning and Representation in Medical Research Act, S. 2745	April 6	No Direct Parallel House Cures has Sec. 1083 (on age exclusion in research) and Sec. 1101 (on standardizing registry data)	Senate bill calls NIH to include more women and minorities in clinical trials and research. House bill calls on NIH to hold a workshop on "appropriate age groupings" and "age exclusion" in human research; and states in Sec. 1101 that clinical registry data has to be standardized to include criteria such as age and gender.

Innovation Bill Scorecard: Device, Diagnostic Provisions In Senate And House

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