Provision	Description
Breakthrough devices (Sec. 3051)	Establishes an accelerated development pathway (data development through post-approval) for devices that address unmet needs for life-threatening or irreversibly debilitating conditions. Open to devices pursuing PMA, de novo and 510(k) pathways. It is similar to the FDA device center's current Expedited Access Pathway, except for the addition of 510(k)s.
Humanitarian device exemptions (Sec. 3052)	To obtain a humanitarian device exemption, a product sponsor would have to be pursuing an indication for a product intended to treat a disease that affects no more than 8,000 people. Previously, the HDE disease ceiling was 4,000 people.
Recognition of standards (Sec. 3053)	Any person may request that FDA recognize an internationally- or domestically-developed industry standard on devices, and gives the agency 60 days of review to accept all, part or none of the standard, and requires staff to be trained in the standard.
510(k)-exemption process for class I and II devices (Sec. 3054)	Directs FDA to publish lists of class I and II device types that no longer require 510(k) clearance every five years (beginning three to fourth months after enactment) and implement the exemptions.
Classification advisory committee meeting (Sec. 3055)	Adds measures to ensure that several members sitting on an FDA advisory panel that is considering device classifications has expertise to the relevant device types and to provide device sponsors to present at such panels, among other process reforms.
Centralized institutional review boards (Sec. 3056)	Removes the requirement that local IRBs must approve device trials.
CLIA waiver rule/guidance update (Sec. 3057)	Requires FDA to revise its 2008 guidance on CLIA waivers for in vitro diagnostics to replace a gold-stand accuracy requirements with an emphasis on comparing test accuracy in waived and moderately complexity labs. (Also see "Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform" - Medtech Insight, 6 June, 2014.)
Least-burdensome requirements (Sec. 3058)	Further emphasizes the "least burdensome" concept for device regulation by requiring auditing of FDA's use of least-burdensome methods, and includes other clarifications.
Cleaning/validation for reusable devices (Sec. 3059)	Requires FDA to publish a list of reusable devices that require instructions for use and validation data for cleaning, disinfection and sterilization. And it requires FDA to finalize its 510(k) modifications draft guidance by November 2017. (Also see "Industry Urges FDA To Distinguish Between 510(k) Modification Factors" - Medtech Insight, 15 November, 2016.)
Medical software regulation reforms (Sec. 3060)	Identifies five specific categories of medical software that, given certain conditions, will not be regulated by FDA as a device.
Combination products innovation (Sec. 3038)	Requires FDA to meet with combination-product sponsors early in the development process; clarifies the dispute resolution process when two product centers do not agree; and seeks to streamline the review process by clarifying that FDA should not designate a combination product as having a drug primary mode of action simply because it includes a chemical action and allowing the agency take into account prior findings of safety and effectiveness of combo-product components. (Also see "Senate Bill Aimed At Streamlining Combo Product Regulation" - Medtech Insight, 20 July, 2015.)
FDA inter-center institutes (Sec. 3073)	Requires FDA to pilot one or more inter-center institutes to coordinate activities in major disease areas between the device, drug and biologics centers.
FDA workforce (Sec. 3071-2, 4)	Provides FDA with more hiring and salary flexibility to attract experts and allows more access by FDA scientists to attend conferences.
Devices used with regenerative advanced therapies (Sec. 3034)	Devices used for the recovery, isolation or delivery of advanced regenerative advanced therapies will be classified as moderate-risk devices, unless FDA determines a high-risk classification is necessary.
Antimicrobial susceptibility testing devices (Sec. 3044)	Establishes specific standards for clearance or approval of an antimicrobial susceptibility assay as part of a newly established process for publicizing and adopting susceptibility test interpretative criteria.
Precision Medicine Initiative (Secs. 1001 and 2011)	Provides $1.4bn through fiscal year 2026 and establishes the necessary authorities at various agencies to carry out the Precision Medicine Initiative that was launched by the Obama administration. (Also see "Precision Medicine Plan 'Golden Opportunity' For Device, Diagnostic Firms" - Medtech Insight, 18 September, 2015.)
BRAIN Initiative (Sec. 1001)	Includes about $1.6bn for the Brain Research Through Advancing Neurotechnologies Initiative. (Also see "Three Next-Gen Prosthetics Projects To Receive BRAIN Funding" - Medtech Insight, 10 February, 2015.)
Cancer Moonshot (Sec. 1001)	Provides $1.8bn to fund a coordinated effort to accelerate drug therapy and diagnosis. (Also see "'Moonshot' Opportunities: Dx Reimbursement, Radiation Therapy Among Medtech Focal Points" - Medtech Insight, 29 June, 2016.)
Sunshine Act revisions	Revises the 2010 Physician Payment Sunshine Act to remove the disclosure requirement for continuing medical education and medical journal reprints and textbooks, and its exempts physicians who received "indirect payments" for speaker fees.
Medicare local coverage determinations (Sec. 4010)	Takes steps to improve transparency for LCDs and to increase accountability for Medicare contractors.
Telehealth services (Sec. 4013)	Encourages actions to expand support for telehealth by Medicare.
Medicaid DME reimbursement (Sec. 5002)	Part of the pay-for provisions for the bill, the bill moves up the date of when Medicaid reimbursement for durable medical equipment must be limited to Medicare competitively bid rates to January 2018.

House Set To Vote On Cures Nov. 30; Latest Version Includes 510(k)s In Breakthrough Pathway

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