,,ii #aadth ,,congress #ast ,session ,s4 #ajgg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bc1 #bjae ,mr4 ,burr 7for himself1 ,mr4 ,bennet1 and ,mr4 ,hatch7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to provide for expedited development of and priority review for breakthrough devices4 #a4 ,short title ,this ,act may be cited as the ,advancing ,breakthrough ,devices for ,patients ,act of #bjae4 #b4 ,expedited development of and priority review for breakthrough devices 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eae;,a the following3 #eae;,b4 ,expedited development of and priority review for breakthrough devices 7a7 ,in general ,in order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions1 the ,secretary shall establish a program to expedite the development of and provide for the priority review for devices-- 7#a7 representing breakthrough technologies2 7#b7 for which no approved alternatives exist2 7#c7 offering significant advantages over existing approved or cleared alternatives1 including the potential1 compared to existing approved alternatives1 to reduce or eliminate the need for hospitalization1 improve patient quality of life1 facilitate patients' ability to manage their own care 7such as through self-directed personal assistance71 or establish long-term clinical efficiencies2 or 7#d7 the availability of which is in the best interest of patients4 7b7 ,request for designation ,a sponsor of a device may request that the ,secretary designate the device for expedited development and priority review under this section4 ,any such request for designation may be made at any time prior to the submission of an application under section #eae7;c71 a petition for classification under section #eac7;f77#b71 or a notification under section #eaj7k74 7c7 ,designation ,process 7#a7 ,in general ,not later than #fj calendar days after the receipt of a request under subsection 7b71 the ,secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection 7a74 ,if the ,secretary determines that the device meets the criteria1 the ,secretary shall designate the device for expedited development and priority review4 7#b7 ,review ,review of a request under subsection 7b7 shall be undertaken by a team that is composed of experienced staff and managers of the ,food and ,drug ,administration and is chaired by a senior manager4 7#c7 ,withdrawal ,the ,secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection 7a7 no longer applying because of the subsequent clearance or approval of another device that-- 7,a7 was designated under this section2 or 7,b7 was given priority review under section #eae7;d77#e71 as in effect prior to the date of enactment of the ,advancing ,breakthrough ,devices for ,patients ,act of #bjae4 7d7 ,expedited ,development and ,priority ,review 7#a7 ,actions ,for purposes of expediting the development and review of devices designated under subsection 7c7 the ,secretary shall-- 7,a7 assign a team of staff1 including a team leader with appropriate subject matter expertise and experience1 for each device for which a request is submitted under subsection 7b72 7,b7 provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection 7b7 for the device2 7,c7 adopt an efficient process for timely dispute resolution2 7,d7 provide for interactive and timely communication with the sponsor of the device during the development program and review process2 7,e7 expedite the ,secretary's review of manufacturing and quality systems compliance1 as applicable2 7,f7 disclose to the sponsor not less than #e business days in advance the topics of any consultation the ,secretary intends to undertake with external experts or an advisory committee concerning the sponsor's device and provide the sponsor the opportunity to recommend such external experts2 7,g7 provide for advisory committee input1 as the ,secretary determines appropriate 7including in response to the request of the sponsor7 for applications submitted under section #eae7;c72 and 7,h7 assign staff to be available within a reasonable time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section #ebj7;g74 7#b7 ,additional actions ,in addition to the actions described in paragraph 7#a71 for purposes of expediting the development and review of devices designated under subsection 7c71 the ,secretary1 in collaboration with the device sponsor1 may1 as appropriate-- 7,a7 coordinate with the sponsor regarding early agreement on a data development plan2 7,b7 take steps to ensure that the design of clinical trials is as efficient as practicable1 when scientifically appropriate1 such as through adoption of shorter or smaller clinical trials1 application of surrogate endpoints1 and the use of adaptive trial designs and ,bayesian statistics1 to the extent scientifically appropriate2 7,c7 facilitate1 when scientifically appropriate1 expedited and efficient development and review of the device through utilization of timely post-market data collection with regard to application for approval under section #eae7;c72 and 7,d7 agree in writing to clinical protocols that the ,secretary will consider binding on the ,secretary and the sponsor1 subject to-- 7i7 changes to such protocols agreed to in writing by the sponsor and the ,secretary2 or 7ii7 a decision1 made by the director of the office responsible for reviewing the device submission1 that a substantial scientific issue essential to determining the safety or effectiveness of such device exists1 provided that such decision is in writing1 and is made only after the ,secretary provides to the device sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the substantial scientific issue4 7e7 ,priority ,review ,guidance 7#a7 ,content ,not later than #a year after the date of enactment of the ,advancing ,breakthrough ,devices for ,patients ,act of #bjae1 the ,secretary shall issue guidance on the implementation of this section4 ,such guidance shall-- 7,a7 set forth the process by which a person may seek a designation under subsection 7c72 7,b7 provide a template for requests under subsection 7b72 7,c7 identify the criteria the ,secretary will use in evaluating a request for designation under this section2 and 7,d7 identify the standards the ,secretary will use in assigning a team of staff1 including team leaders1 to review devices designated for expedited development and priority review1 including any training required for such personnel to ensure effective and efficient review4 7#b7 ,process ,prior to finalizing the guidance under paragraph 7#a71 the ,secretary shall seek public comment on a proposed guidance4 7f7 ,construction 7#a7 ,purpose ,this section is intended to encourage the ,secretary and provide the ,secretary sufficient authorities to apply efficient and flexible approaches to expedite the development of1 and prioritize the ,food and ,drug ,administration's review of1 devices that represent breakthrough devices4 7#b7 ,rule of construction ,nothing in this section shall be construed to affect-- 7,a7 the criteria and standards for evaluating an application pursuant to section #eae7;c71 a report and request for classification under section #eac7;f77#b71 or a report under section #eaj7k71 including the recognition of valid scientific evidence as described in section #eac7;a77#c77;,b7 and consideration and application of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics1 as applicable2 7,b7 the authority of the ,secretary with respect to clinical holds under section #ebj7;g77#h77;,a72 or 7,c7 the authority of the ,secretary to act on an application pursuant to section #eae7;d7 before completion of an establishment inspection1 as the ,secretary determines appropriate4 4 7b7 ,documentation and review of significant decisions ,section #eag;,a7a77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;g-#a7;a77#a77 is amended by inserting a request for designation under section #eae;,b1 after application under section #eae14 7c7 ,termination of previous program 7#a7 ,in general ,section #eae7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e7d77 is amended-- 7,a7 by striking paragraph 7#e72 and 7,b7 by redesignating paragraph 7#f7 as paragraph 7#e74 7#b7 ,conforming amendment ,section #gcg7e7 of the ,federal ,food1 ,drug1 and ,cosmetics ,act 7#ba ,u4,s4,c4 #cgi;i7#e77 is amended by striking #eae7;d77#f7 and inserting #eae7;d77#e74