Both the House and the Senate are considering legislation to support medical innovation, primarily through reforms to the National Institutes of Health (NIH) and changes to the drug, biologic and device approval pathways at the Food and Drug Administration (FDA). Both NIH and FDA are agencies within the Department of Health and Human Services (HHS). On February 3, 2015 Senators Lamar Alexander and Patty Murray, chairman and ranking Member of the Committee on Health, Education, Labor and Pensions, announced the start of a bipartisan initiative to "examine the process for getting safe treatments, devices and cures to patients and the roles of the [FDA] and the [NIH] in that process." This initiative culminated in a package of 19 bipartisan bills that were reported out of the Senate Health, Labor, Education, and Pensions (HELP) Committee in a series of three executive sessions held on February 9, 2016; March 9, 2016; and April 6, 2016. One of these 19 bills, The Adding Zika Virus to the FDA Priority Review Voucher Program Act (S. 2512), subsequently was passed by both chambers and signed into law on April 19, 2016 (P.L. 114-146). The remaining 18 bills that comprise the Senate's medical innovation legislative effort include the following: S. 1878, The Advancing Hope Act of 2015; S. 1622, The FDA Device Accountability Act of 2015; S. 2503, Preventing Superbugs and Protecting Patients Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 2014, Next Generation Researchers Act; S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2511, Improving Health Information Technology Act; S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015; S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act; S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 1767, The Combination Products Innovation Act of 2015; S. 1597, Patient Focused Impact Assessment Act of 2015; S. 185, Promise for Antibiotics and Therapeutics for Health Act; S. 2713, Advancing Precision Medicine Act of 2016; S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S. 2742, Promoting Biomedical Research and Public Health for Patients Act; and S. 2700, FDA and NIH Workforce Authorities Modernization Act. The Senate's medical innovation package is that chamber's companion effort to the House's 21 st Century Cures initiative, which culminated in the House passage of H.R. 6 , the 21 st Century Cures Act, on July 10, 2015, on a vote of 344 to 77. H.R. 6 is the result of a series of hearings and roundtable meetings hosted by the House Energy and Commerce Committee dating back to spring 2014. The hearings and roundtables focused on a broad range of topics, including modernizing clinical trials, incorporating patient perspectives into medical research and regulatory processes, precision/personalized medicine, digital health care, and more. While consisting of many different provisions, H.R. 6 is primarily focused on efforts to increase strategic investments in medical research at NIH and change some aspects of how the FDA executes its regulatory oversight mission with regard to the review and approval of new drugs, biologics, and medical devices. This report provides for each of the 18 bills in the Senate medical innovation package: (1) background on the issue, or issues, addressed by the bill including a summary of relevant current law; (2) a summary of the bill's provisions; and (3) where applicable, identification of comparable provisions in H.R. 6 that address the same topic. In some cases, the House and Senate legislation address the same topic in an entirely different way. In other cases, the House and Senate legislation address the topic in a similar way but with key substantive differences. In a few instances, the language in the House and Senate bills is substantively identical. For a summary of all the provisions in H.R. 6 , as passed by the House, including an explanation of how the bill would change current law, see CRS Report R44071, H.R. 6: The 21st Century Cures Act . The HHS Human Subject Regulations are a core set of federal standards for protecting human subjects in HHS-sponsored research. These regulations are commonly referred to as the Common Rule because the same requirements have been adopted by many other federal departments and agencies, which apply the regulations to the research they fund. Under the Common Rule, research protocols must be approved by an Institutional Review Board (IRB) to ensure that the rights and welfare of research subjects are protected. FDA has issued its own set of Human Subject Regulations, which are similar, but not identical, to the Common Rule. FDA applies these regulations to all the research it regulates, including clinical trials of new drugs and medical devices, regardless of the source of funding for the research. All clinical evaluations of investigational devices (unless exempt) must have an investigational device exemption (IDE) before the clinical study is initiated. An IDE allows an unapproved device (most commonly an invasive or life-sustaining device) to be used in a clinical study to collect the data required to support a premarket approval (PMA) submission. The IDE permits a device to be shipped lawfully for investigation of the device without requiring that the manufacturer comply with other requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA), such as registration and listing. Devices approved by FDA via the humanitarian device exemption (HDE) are for diagnosing or treating diseases or conditions that affect fewer than 4,000 individuals in the United States each year. An HDE application is similar to a PMA, but it is exempt from the effectiveness requirements. Such devices may be used in a facility only after a local IRB has approved their use in that facility, except in certain emergency situations. The provision would amend Section 520(g) of the FFDCA, regarding IDEs, and Section 520(m) of the FFDCA, regarding HDEs, by removing the word "local" in all references to local IRBs, including in the stipulation that an approved humanitarian use device may be used in a facility only after a local IRB has approved such use, except in certain emergency situations. The use of non-local IRBs for review of IDEs and HDEs provision in H.R. 6 (i.e., Title II, Subtitle O, Section 2262) is comparable to S. 1622 . The House provision would also require the Secretary, within 12 months of enactment, to revise or issue regulations or guidance, as necessary, to carry out these amendments. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 provide the Centers for Medicare & Medicaid Services (CMS) with authority to regulate clinical laboratories to ensure the accuracy of test results, given that these results drive clinical decisionmaking. CLIA requires laboratories to receive certification before they are allowed to carry out clinical laboratory testing on a human sample. CLIA certification is based on the level of complexity of testing that a laboratory is performing, graded as low, moderate, or high. FDA is responsible for categorizing clinical laboratory tests according to their level of complexity. Laboratories that perform only low-complexity tests (called waived tests ) receive a certificate of waiver (COW) from CMS. Conversely, only laboratories certified to do so may perform moderate- and high-complexity tests. FDA determines whether a test is waived (i.e., low-complexity) or not based on information submitted about the test by the manufacturer, and FDA has issued guidance to support the manufacturer's submission of this information. Under current law, waived tests are those "that have been approved by FDA for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result." The guidance recommends ways to demonstrate that a test is both "simple" and has "an insignificant risk of an erroneous result." Demonstrating the latter includes showing that a test's accuracy is comparable to a method whose accuracy has already been established and documented. (Section V of the guidance document addresses approaches to demonstrating accuracy.) S. 1622 Section 3 would require the Secretary, not later than one year after enactment, to publish draft guidance that revises Section V of the current guidance, including providing clarification on the appropriate use of comparable performance between a waived and moderately complex laboratory user to demonstrate accuracy. Not later than one year after the comment period for the draft guidance closes, the Secretary would be required to publish final revised guidance. Section 2228 of H.R. 6 (Title I, Subtitle M) is substantively identical to the Senate legislation. Section 205 of the Food and Drug Administration Modernization Act of 1997 (FDAMA, P.L. 105-115 ) amended Section 513 of the Federal Food, Drug, and Cosmetic Act (FFDCA), adding two provisions commonly referred to as the "Least Burdensome Provisions." The two provisions stipulate that FDA consider the "least burdensome" data or information "necessary" to demonstrate a reasonable assurance of device effectiveness in a premarket approval (PMA) application or substantial equivalence to predicate devices with differing technological characteristics in certain 510(k) notifications. The two provisions are as follows: Section 513(a)(3)(D)(ii) Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as a result of a determination by the Secretary that such data are necessary to establish device effectiveness.