Definition: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Input: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Disclosure; and Encouragement of
Verification, Innovation, Cleaning, and Efficiency Act of 2016''.

SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND REPROCESSING INSTRUCTION
CHANGES.

(a) Adulteration.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
(j) the following:
''(k) If it is a device with respect to which the manufacturer is
in violation of the reporting requirement in section 510(q) (relating
to design and reprocessing changes).''.
(b) Requirement.--Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the
following:
''(q) Reporting Requirement for Device Design Changes.--Before
making a change to the design of a device, or the reprocessing
instructions of a device, that is marketed in interstate commerce, the
manufacturer of the device shall give written notice of the change to
the Food and Drug Administration.''.

SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMUNICATIONS TO FOREIGN
HEALTH CARE PROVIDERS.

(a) Adulteration.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351), as amended by section 2 of this Act, is
further amended by inserting after paragraph (k) the following:
''(l) If it is a device with respect to which the manufacturer is
in violation of the reporting requirement in section 510(r) (relating
to communications to foreign health care providers).''.
(b) Requirement.--Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360), as amended by section 2 of this Act, is
further amended by adding at the end the following:
''(r) Reporting Requirement for Certain Communications to Foreign
Health Care Providers.--
''(1) Requirement.--The manufacturer of a device that is
marketed in interstate commerce shall give written notice to
the Food and Drug Administration of any communication described
in paragraph (2) not more than 5 calendar days after making
such communication.
''(2) Communication described.--A communication is
described in this paragraph if the communication--
''(A) is made by the manufacturer of the device or
an affiliate of the manufacturer;
''(B) relates to a change to the design of the
device, a change to the recommended reprocessing
protocols, if any, for the device, or a safety concern
about the device; and
''(C) is widely disseminated (including on a
voluntary basis) to health care providers in a foreign
country.
''(3) Affiliate.--In this subsection, the term 'affiliate'
means a business entity that has a relationship with a second
business entity if, directly or indirectly--
''(A) one business entity controls, or has the
power to control, the other business entity; or
''(B) a third party controls, or has the power to
control, both of the business entities.''.

SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE PROPER REPROCESSING.

(a) Inclusion in Device Definition.--Section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
(1) in paragraph (h)--
(A) in subparagraph (2), by striking ''or'' at the
end;
(B) in subparagraph (3), by striking ''and'' at the
end and inserting ''or''; and
(C) by inserting after subparagraph (3) the
following:
''(4) a rapid assessment test intended to ensure the proper
reprocessing of a reusable device (as defined in paragraph
(ss)), and''; and
(2) by adding at the end the following:
''(ss) The term 'reusable device' means a device that--
''(1) is intended to be used more than one time; and
''(2) must be sanitized (whether through cleaning,
disinfection, or sterilization) to ensure that the device is
safe and effective for such intended use.''.
(b) Instructions for Use and Validation Data.--Section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by
sections 2 and 3 of this Act, is further amended by adding at the end
the following:
''(s) Instructions for Use and Validation Data.--
''(1) Initial list.--Not later than 1 year after the date
of enactment of this subsection, the Secretary shall by
regulation develop and publish a list of types of rapid
assessment tests described in section 201(h)(4) for which
reports under subsection (k) must include--
''(A) instructions for use that have been validated
in a manner specified by the Secretary; and
''(B) validation data, of the types specified by
the Secretary.
''(2) Updates.--The Secretary shall by regulation
periodically update the list required by paragraph (1).
''(3) Enforcement.--Beginning on the date of publication of
the initial list under paragraph (1), the Secretary shall not
accept any notification under subsection (k) for clearance of a
type of rapid assessment test that is included on such list
unless such notification includes instructions for use and
validation data in accordance with paragraph (1).''.
Output:
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act by requiring a manufacturer of a medical device to give the Food and Drug Administration (FDA) premarket notification of changes to the design or reprocessing instructions of its device. Medical device manufacturers must also notify the FDA within five days of widely disseminating to health care providers in a foreign country communications relating to a change to the recommended reprocessing protocols, if any, for their device, or a safety concern about the device. The bill bans the devices if the manufacturers violate the notification requirements concerning those design or reprocessing changes or communications to foreign health care providers. The FDA must publish a list of the types of rapid assessment tests of reusable devices for which premarket notification must include proposed labeling, including validated instructions regarding sanitizing reusable devices.