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OCT. 26,

Oct. 26, 2002 [H.R. 5651)

Medical Device
User Fee and
Modernization
Act of 2002.
21 USC 301 note.

Public Law 107-250
107th Congress

An Act
To amend the Federal Food, Drug, and Cosmetic Act to make improvements in

the regulation of medical devices, and for other purposes.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the “Medical Device User Fee and Modernization Act of 2002”.

(b) TABLE OF CONTENTS.—The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.

TITLE I-FEES RELATED TO MEDICAL DEVICES
Sec. 101. Findings.
Sec. 102. Establishment of program.
Sec. 103. Annual reports.
Sec. 104. Postmarket surveillance.
Sec. 105. Consultation.
Sec. 106. Effective date.
Sec. 107. Sunset clause.
TITLE II—AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES
Sec. 201. Inspections by accredited persons.
Sec. 202. Third party review of premarket notification.
Sec. 203. Debarment of accredited persons.
Sec. 204. Designation and regulation of combination products.
Sec. 205. Report on certain devices.
Sec. 206. Electronic labeling.
Sec. 207. Electronic registration.
Sec. 208. Intended use.
Sec. 209. Modular review.
Sec. 210. Pediatric expertise regarding classification-panel review of premarket ap-

plications.
Sec. 211. Internet list of class II devices exempted from requirement of premarket

notification.
Sec. 212. Study by Institute of Medicine of postmarket surveillance regarding pedi-

atric populations.
Sec. 213. Guidance regarding pediatric devices.
Sec. 214. Breast implants; study by Comptroller General.
Sec. 215. Breast implants; research through National Institutes of Health.

TITLE III–ADDITIONAL AMENDMENTS
Sec. 301. Identification of manufacturer of medical devices,
Sec. 302. Single-use medical devices.
Sec. 303. MedWatch.

TITLE I-FEES RELATED TO MEDICAL

DEVICES

21 USC 379i note.

SEC. 101. FINDINGS.
The Congress finds that-

(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease;

(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and

(3) the fees authorized by this title will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate,

as set forth in the Congressional Record. SEC. 102. ESTABLISHMENT OF PROGRAM.

(a) IN GENERAL.-Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379F et seq.) is amended by adding at the end the following part:

“PART 3-FEES RELATING TO DEVICES

21 USC 379i.

"SEC. 737. DEFINITIONS.
“For purposes of this subchapter:
"(1) The term 'premarket application' means-

"(A) an application for approval of a device submitted
under section 515(c) or section 351 of the Public Health
Service Act; or

“(B) a product development protocol described in section 515(f). Such term does not include a supplement, a premarket report, or a premarket notification submission.

"(2) The term “premarket report' means a report submitted under section 515(c)(2).

"(3) The term 'premarket notification submission' means a report submitted under section 510(k).

“(4)(A) The term “supplement, with respect to a paneltrack supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which

"(i) an application or report has been approved under section 515(d), or an application has been approved under section 351 of the Public Health Service Act; or

"(ii) a notice of completion has become effective under section 515(f).

"(B) The term 'panel-track supplement' means a supplement to an approved premarket application or premarket report under section 515 that requests a significant change in design or performance of the device, or a new indication for use of

-OCT. 26,

the device, and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness.

"(C) The term '180-day supplement' means a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.

“(D) The term 'real-time supplement means a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, manufacturing, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.

"(E) The term 'efficacy supplement' means a supplement to an approved premarket application under section 351 of the Public Health Service Act that requires substantive clinical data.

“(5) The term 'process for the review of device applications' means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, and premarket notification submissions:

“(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.

"(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.

"(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary's review of pending premarket applications, premarket reports, and supplements.

“(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, and submissions.

"(E) Review of device applications subject to section 351 of the Public Health Service Act for an investigational new drug application under section 505(i) or for an investigational device exemption under section 520(g) and activities conducted in anticipation of the submission of such applications under section 505(i) or 520(g).

"(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.

"(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under section 514 in connection with the review of such applications, reports, supplements, or submissions and related activities.

"(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions.

“(I) Any activity undertaken under section 513 or 515(i) in connection with the initial classification or reclassification of a device or under section 515(b) in connection with any requirement for approval of a device.

"(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application under section 515 or section 351 of the Public Health Service Act.

"(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification submissions.

"(6) The term 'costs of resources allocated for the process for the review of device applications' means the expenses incurred in connection with the process for the review of device applications for

"(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;

"(B) management of information, and the acquisition, maintenance, and repair of computer resources;

"(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

"(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, and submissions.

(7) The term 'adjustment factor applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 2002.

“(8) 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 power to control,

both of the business entities. "SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES.

"(a) TYPES OF FEES.—Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002, the Secretary shall assess and collect fees in accordance with this section as follows:

“(1) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLEMENT, AND SUBMISSION FEE.

(A) IN GENERAL.—Except as provided in subparagraph (B) and subsection (d), each person who submits any of the following, on or after October 1, 2002, shall be subject to a fee established under subsection (c)(5) for the fiscal year involved in accordance with the following:

"(i) A premarket application.

21 USC 379j.

"(ii) For a premarket report, a fee equal to the fee that applies under clause (i).

"(iii) For a panel track supplement, a fee equal to the fee that applies under clause (i).

"(iv) For a 180-day supplement, a fee equal to 21.5 percent of the fee that applies under clause (i), subject to any adjustment under subsection (c)(3).

"(v) For a real-time supplement, a fee equal to 7.2 percent of the fee that applies under clause (i).

a(vi) For an efficacy supplement, a fee equal to the fee that applies under clause (i).

"(vii) For a premarket notification submission, a fee equal to 1.42 percent of the fee that applies under clause (i), subject to any adjustment under subsection (c)(3) and any adjustment under subsection (e)(2)(C)(ii). “(B) EXCEPTIONS.—

"(i) HUMANITARIAN DEVICE EXEMPTION.-An application under section 520(m) is not subject to any fee under subparagraph (A).

"(ii) FURTHER MANUFACTURING USE.—No fee shall be required under subparagraph (A) for the submission of a premarket application under section 351 of the Public Health Service Act for a product licensed for further manufacturing use only.

"(iii) STATE OR FEDERAL GOVERNMENT SPONSORS. No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.

“(iv) PREMARKET NOTIFICATIONS BY THIRD PARTIES.—No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 523. "(v) PEDIATRIC CONDITIONS OF USE.

"(I) IN GENERAL.—No fee shall be required under subparagraph (A) for a premarket application, premarket report, or premarket notification submission if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.

“(II) SUBSEQUENT PROPOSAL OF ADULT CONDITIONS OF USE.—In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket

application. “(C) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted

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