‘‘(vii) Any response by the applicant to a re-
quest described in clause (v) or a deficiency letter. 
‘‘(viii) Any written submission by the applicant 
to the Food and Drug Administration. 
‘‘(ix) Any other matter, as determined appro-
priate by the Secretary. 
‘‘(9) Upon the submission of an application for an 
exemption under this subsection for a device, the Sec-
retary shall assign, to review the application, a reviewer 
with prior review experience with that type of device or 
technology or other relevant expertise.’’. 
SEC. 3. OTHER RULES RELATING TO INVESTIGATIONAL DE-
VICE EXEMPTIONS. 
Section 520(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360j(g)) is amended— 
(1) in paragraph (2)(A), by adding at the end 
the following: ‘‘Procedures and conditions pursuant 
to the preceding sentence shall require the Sec-
retary, in determining whether to grant such an ex-
emption, to evaluate whether the investigational 
study can be conducted ethically and with reasonable 
risk.’’; 
(2) in paragraph (2)(B)(ii), by striking ‘‘evalu-
ate the safety and effectiveness of the device’’ and 
inserting ‘‘evaluate whether the investigational study 
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is being conducted ethically and with reasonable 
risk’’; 
(3) in paragraph (4)(B), by adding at the end 
the following: ‘‘The Secretary may not disapprove an 
application because the investigation does not or 
may not meet any requirement, including a data re-
quirement, relating to the approval or clearance of 
a device because the Secretary believes that a dif-
ferent clinical testing design or plan could produce 
data more relevant to an approval or clearance deci-
sion.’’; 
(4) in paragraph (7)(A), by striking ‘‘(7)(A) In 
the case’’ and all that follows through the end para-
graph (7)(A) and inserting the following: 
‘‘(7)(A)(i) In the case of a person intending to inves-
tigate the safety or effectiveness of a class II or a class 
III device, the Secretary shall ensure that the person has 
an opportunity, prior to submitting an application to the 
Secretary, to submit to the Secretary, for review, an inves-
tigational plan (including a clinical protocol). If the appli-
cant submits a written request for a meeting with the Sec-
retary regarding such review, the Secretary shall, not later 
than 30 days after receiving the request, meet with the 
applicant for the purpose of reaching agreement regarding 
the investigational plan (including a clinical protocol). The 
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written request shall include a detailed description of the 
device, a detailed description of the proposed conditions 
of use of the device, information (if available) regarding 
the expected performance of the device, and a proposed 
plan (including a clinical protocol) for determining— 
‘‘(I) whether there is a reasonable assurance of 
safety and effectiveness; or 
‘‘(II) whether the device is substantially equiva-
lent to or is at least as safe and effective as a legally 
marketed device that is not subject to approval re-
quirements under section 515. 
‘‘(ii) In the case where the Secretary fails to meet 
the applicant not later than 30 days after receiving a re-
quest as described under clause (i), the proposed plan sub-
mitted in such request shall be deemed to be the agree-
ment reached between the Secretary and the applicant 
under subparagraph (B) and such agreement shall not be 
subject to change except as provided in subparagraph 
(B).’’; and 
(5) in paragraph (7)(B)(ii), by inserting ‘‘that 
has emerged since the date of the agreement and 
that is’’ after ‘‘substantial scientific issue’’. 
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PWALKER on DSK5TPTVN1PROD with BILLS
SEC. 4. CLARIFICATION OF LEAST BURDENSOME STAND-
ARD. 
(a) PREMARKET APPROVAL.—Section 513(a)(3)(D) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c(a)(3)(D)) is amended— 
(1) by redesignating clause (iii) as clause (iv); 
and 
(2) by inserting after clause (ii) the following: 
‘‘(iii) In carrying out clause (ii), the Secretary— 
‘‘(I) shall not request information unrelated or 
irrelevant to a demonstration of reasonable assur-
ance of device effectiveness; 
‘‘(II) shall consider alternative approaches to 
evaluating device effectiveness in order to reduce the 
time, effort, and cost of reaching proper resolution 
of the issue; 
‘‘(III) shall use all reasonable mechanisms to 
lessen review times and render regulatory decisions; 
‘‘(IV) shall consider whether pre-clinical data, 
such as well-designed bench and animal testing, can 
meet the statutory threshold for approval; and 
‘‘(V) if clinical data are needed, shall consider 
alternatives to randomized, controlled clinical trials 
and the use of surrogate endpoints.’’. 
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PWALKER on DSK5TPTVN1PROD with BILLS
(b) 
SUBSTANTIAL
EQUIVALENCE
DETERMINA-
TION.—Section 513(i)(1)(D) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(i)(1)(D)) is amended— 
(1) by striking ‘‘(D) Whenever’’ and inserting 
‘‘(D)(i) Whenever’’; and 
(2) by adding at the end the following: 
‘‘(ii) In carrying out clause (i), the Secretary— 
‘‘(I) shall focus on whether there is a reason-
able assurance that the device is safe and effective 
for its intended use; 
‘‘(II) shall not request or accept information 
unrelated or irrelevant to the substantial equivalence 
evaluation; 
‘‘(III) shall review the labeling of the device to 
assess the intended use of the device, and shall not 
evaluate issues that do not present a major impact 
on the intended use as set forth in the labeling; 
‘‘(IV) shall consider alternative approaches to 
evaluating substantial equivalence in order to reduce 
the time, effort, and cost of reaching proper resolu-
tion of the issue; and 
‘‘(V) shall use all reasonable mechanisms to 
lessen review times and render regulatory deci-
sions.’’. 
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