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Such report also shall include the Secretary's specific recommendation on whether responsibility for regulating such devices should be reassigned to those persons within the Food and Drug Administration who are primarily charged with regulating other types of devices, and whether such a transfer could have a deleterious impact on the public health and on the safety of such devices. SEC. 206. ELECTRONIC LABELING.
Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end the following: "Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.".
SEC. 207. ELECTRONIC REGISTRATION.
Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the following:
"(p) Registrations under subsections (b), (c), (d), and (i) (including the submission of updated information) shall be submitted to the Secretary by electronic means, upon a finding by the Secretary that the electronic receipt of such registrations is feasible, unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.".
SEC. 208. INTENDED USE.
Section 513(i)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)(1)(E)) is amended by striking clause (iv).
SEC. 209. MODULAR REVIEW.
Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by adding at the end the following:
"(3)(A) Prior to the submission of an application under this subsection, the Secretary shall accept and review any portion of the application that the applicant and the Secretary agree is complete, ready, and appropriate for review, except that such requirement does not apply, and the Secretary has discretion whether to accept and review such portion, during any period in which, under section 738(g), the Secretary does not have the authority to collect fees under section 738(a).
"(B) Each portion of a submission reviewed under subparagraph (A) and found acceptable by the Secretary shall not be further reviewed after receipt of an application that satisfies the requirements of paragraph (1), unless an issue of safety or effectiveness provides the Secretary reason to review such accepted portion.
"(C) Whenever the Secretary determines that a portion of a submission under subparagraph (A) is unacceptable, the Secretary shall, in writing, provide to the applicant a description of any deficiencies in such portion and identify the information that is required to correct these deficiencies, unless the applicant is no longer pursuing the application.".
21 USC 360/ note.
21 USC 360j note. Deadline.
SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL
Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), as amended by section 302(c)(2)(A) of this Act, is amended in paragraph (3) by adding at the end the following: "Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts.".
SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM
Section 510(m)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)(1)) is amended by adding at the end the following: "The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary.".
SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET
(a) IN GENERAL.-The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study for the purpose of determining whether the system under the Federal Food, Drug, and Cosmetic Act for the postmarket surveillance of medical devices provides adequate safeguards regarding the use of devices in pediatric populations.
(b) CERTAIN MATTERS.-The Secretary shall ensure that determinations made in the study under subsection (a) include determinations of
(1) whether postmarket surveillance studies of implanted medical devices are of long enough duration to evaluate the impact of growth and development for the number of years that the child will have the implant, and whether the studies are adequate to evaluate how children's active lifestyles may affect the failure rate and longevity of the implant; and
(2) whether the postmarket surveillance by the Food and Drug Administration of medical devices used in pediatric populations is sufficient to provide adequate safeguards for such populations, taking into account the Secretary's monitoring of commitments made at the time of approval of medical devices, such as phase IV trials, and the Secretary's monitoring and use of adverse reaction reports, registries, and other postmarket surveillance activities.
(c) REPORT TO CONGRESS.-The Secretary shall ensure that, not later than four years after the date of the enactment of this Act, a report describing the findings of the study under subsection (a) is submitted to the Congress. The report shall include any recommendations of the Secretary for administrative or legislative changes to the system of postmarket surveillance referred to in such subsection.
SEC. 213. GUIDANCE REGARDING PEDIATRIC DEVICES.
Not later than 270 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance on the following:
(1) The type of information necessary to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in pediatric populations.
(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness of such devices.
SEC. 214. BREAST IMPLANTS; STUDY BY COMPTROLLER GENERAL.
(a) IN GENERAL.-The Comptroller General of the United States shall conduct a study to determine the following with respect to breast implants:
(1) The content of information typically provided by health professionals to women who consult with such professionals on the issue of whether to undergo breast implant surgery. (2) Whether such information is provided by physicians or other health professionals, and whether the information is provided verbally or in writing, and at what point in the process of determining whether to undergo surgery is such information provided.
(3) Whether the information presented, as a whole, provides a complete and accurate discussion of the risks and benefits of breast implants, and the extent to which women who receive such information understand the risks and benefits.
(4) The number of adverse events that have been reported, and whether such events have been adequately investigated. (5) With respect to women who participate as subjects in research being carried out regarding the safety and effectiveness of breast implants:
(A) The content of information provided to the women during the process of obtaining the informed consent of the women to be subjects, and the extent to which such information is updated.
(B) Whether such process provides written explanations of the criteria for being subjects in the research.
(C) The point at which, in the planning or conduct of the research, the women are provided information regarding the provision of informed consent to be subjects. (b) REPORT.-The Comptroller General shall submit to the Congress a report describing the findings of the study.
(c) DEFINITION.-For purposes of this section, the term "breast implant" means a breast prosthesis that is implanted to augment or reconstruct the female breast.
SEC. 215. BREAST IMPLANTS; RESEARCH THROUGH NATIONAL
(a) REPORT ON STATUS OF CURRENT RESEARCH.-Not later than 180 days after the date of the enactment of this Act, the Director of the National Institutes of Health shall submit to the Congress a report describing the status of research on breast implants (as defined in section 213(c)) being conducted or supported by such Institutes.
(b) RESEARCH ON LONG-TERM IMPLICATIONS.-Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by adding at the end of the following section:
"SEC. 498C. BREAST IMPLANT RESEARCH.
"(a) IN GENERAL.-The Director of NIH may conduct or support research to examine the long-term health implications of silicone
42 USC 289g-3 note.
42 USC 289g-3.
99-194 O-03-27 : QL 3 Part 2
21 USC 352 note.
21 USC 352 note.
breast implants, both gel and saline filled. Such research studies may include the following:
"(1) Developing and examining techniques to measure concentrations of silicone in body fluids and tissues.
"(2) Surveillance of recipients of silicone breast implants, including long-term outcomes and local complications.
"(b) DEFINITION.-For purposes of this section, the term 'breast implant' means a breast prosthesis that is implanted to augment or reconstruct the female breast.".
TITLE III-ADDITIONAL AMENDMENTS
SEC. 301. IDENTIFICATION OF MANUFACTURER OF MEDICAL DEVICES. (a) IN GENERAL.-Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:
"(u) If it is a device, unless it, or an attachment thereto, prominently and conspicuously bears the name of the manufacturer of the device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, except that the Secretary may waive any requirement under this paragraph for the device if the Secretary determines that compliance with the requirement is not feasible for the device or would compromise the provision of reasonable assurance of the safety or effectiveness of the device.".
(b) EFFECTIVE DATE.-The amendment made by subsection (a) takes effect 18 months after the date of the enactment of this Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.
SEC. 302. SINGLE-USE MEDICAL DEVICES.
(a) REQUIRED STATEMENTS ON LABELING.—
(1) IN GENERAL.-Section 502 of the Federal Food, Drug, and Cosmetic Act, as amended by section 301 of this Act, is amended by adding at the end the following:
"(v) If it is a reprocessed single-use device, unless all labeling of the device prominently and conspicuously bears the statement 'Reprocessed device for single use. Reprocessed by __.' The name of the manufacturer of the reprocessed device shall be placed in the space identifying the person responsible for reprocessing.".
(2) EFFECTIVE DATE.-The amendment made by paragraph (1) takes effect 15 months after the date of the enactment of this Act, and only applies to devices introduced or delivered for introduction into interstate commerce after such effective date.
(b) PREMARKET NOTIFICATION.-Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by inserting after subsection (n) the following:
"(o)(1) With respect to reprocessed single-use devices for which reports are required under subsection (k):
"(A) The Secretary shall identify such devices or types of devices for which reports under such subsection must, in order to ensure that the device is substantially equivalent to a predicate device, include validation data, the types of which shall be specified by the Secretary, regarding cleaning and sterilization, and functional performance demonstrating
that the single-use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification. Within six months after enactment of this subsection, the Secretary shall publish in the Federal Register a list of the types so identified, and shall revise the list as appropriate. Reports under subsection (k) for devices or types of devices within a type included on the list are, upon publication of the list, required to include such validation data.
Federal Register, publication.
"(B) In the case of each report under subsection (k) that Deadline. was submitted to the Secretary before the publication of the initial list under subparagraph (A), or any revision thereof, and was for a device or type of device included on such list, the person who submitted the report under subsection (k) shall submit validation data as described in subparagraph (A) to the Secretary not later than nine months after the publication of the list. During such nine-month period, the Secretary may not take any action under this Act against such device solely on the basis that the validation data for the device have not been submitted to the Secretary. After the submission of the validation data to the Secretary, the Secretary may not determine that the device is misbranded under section 502(o), adulterated under section 501(f)(1)(B), or take action against the device under section 301(p) for failure to provide any information required by subsection (k) until (i) the review is terminated by withdrawal of the submission of the report under subsection (k); (ii) the Secretary finds the data to be acceptable and issues a letter; or (iii) the Secretary determines that the device is not substantially equivalent to a predicate device. Upon a determination that a device is not substantially equivalent to a predicate device, or if such submission is withdrawn, the device can no longer be legally marketed.
"(C) In the case of a report under subsection (k) for a device identified under subparagraph (A) that is of a type for which the Secretary has not previously received a report under such subsection, the Secretary may, in advance of revising the list under subparagraph (A) to include such type, require that the report include the validation data specified in subparagraph (A).
"(D) Section 502(o) applies with respect to the failure of a report under subsection (k) to include validation data required under subparagraph (A).
"(2) With respect to critical or semi-critical reprocessed singleuse devices that, under subsection (1) or (m), are exempt from the requirement of submitting reports under subsection (k):
"(A) The Secretary shall identify such devices or types of devices for which such exemptions should be terminated in order to provide a reasonable assurance of the safety and effectiveness of the devices. The Secretary shall publish in the Federal Register a list of the devices or types of devices so identified, and shall revise the list as appropriate. The exemption for each device or type included on the list is terminated upon the publication of the list. For each report under subsection (k) submitted pursuant to this subparagraph the Secretary shall require the validation data described in paragraph (1)(A).
Federal Register, publication.