Definitions
For purposes of this subpart:
The term “premarket application” means—
an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or
a product development protocol described in section 360e(f) of this title.
Such term does not include a supplement, a premarket report, or a premarket notification submission.
The term “premarket report” means a report submitted under section 360e(c)(2) of this title.
The term “premarket notification submission” means a report submitted under section 360(k) of this title.
The term “supplement”, with respect to a panel-track 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—
an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or
a notice of completion has become effective under section 360e(f) of this title.
The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.
The term “180-day supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.
The term “real-time supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, 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.
The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.
The term “30-day notice” means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.
The term “request for classification information” means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device.
The term “annual fee”, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.
The term “de novo classification request” means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.
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:
The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
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.
The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements.
Monitoring of research conducted in connection with the review of such applications, reports, supplements, and submissions.
Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title.
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.
The development of voluntary test methods, consensus standards, or mandatory performance standards under section 360d of this title in connection with the review of such applications, reports, supplements, or submissions and related activities.
The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions.
Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under section 360e(b) of this title in connection with any requirement for approval of a device.
Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.
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.
The term “costs of resources allocated for the process for the review of device applications” means the expenses in connection with the process for the review of device applications for—
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;
management of information, and the acquisition, maintenance, and repair of computer resources;
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.
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 October of the preceding fiscal year divided by such Index for October 2016.
The term “person” includes an affiliate thereof.
The term “affiliate” means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—
one business entity controls, or has the power to control, the other business entity; or
a third party controls, or has power to control, both of the business entities.
The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.
Source
(June 25, 1938, ch. 675, § 737, as added Pub. L. 107–250, title I, § 102(a),Notes
Termination of Section
Amendments
Effective Date of 2017 Amendment
Effective Date of 2012 Amendment
Effective and Termination Dates of 2007 Amendment
Effective and Termination Dates
Savings Provision
Findings
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;
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
the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and section 379j of 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.”
Annual Reports
In General.—
Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning—
the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of Pub. L. 107–250 does not contain parts]; and
the implementation of the authority for such fees during such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].
Additional Information.—
For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—
information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and
a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than such amounts for fiscal year 2002 multiplied by the adjustment factor, as defined in paragraph (7) [now (10)] of such section 737.”
Study
Consultation
In General.—
In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of medical device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i, 379j], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.
Recommendations.—
The Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.”