PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 843
and Commerce of the House of Representatives, as set forth in the Congressional Record.
Subtitle A—Fees Related to Medical Devices SEC. 211. DEFINITIONS.
dkrause on GSDDPC44 with PUBLAW
Section 737 is amended— (1) in the matter preceding paragraph (1), by striking ‘‘For purposes of this subchapter’’ and inserting ‘‘For purposes of this part’’; (2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively; (3) by inserting after paragraph (4) the following: ‘‘(5) The term ‘30-day notice’ means a notice under section 515(d)(6) that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device. ‘‘(6) The term ‘request for classification information’ means a request made under section 513(g) for information respecting the class in which a device has been classified or the requirements applicable to a device. ‘‘(7) 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.’’; (4) in paragraph (10), as so redesignated— (A) by striking ‘‘April of the preceding fiscal year’’ and inserting ‘‘October of the preceding fiscal year’’; and (B) by striking ‘‘April 2002’’ and inserting ‘‘October 2001’’; (5) by inserting after paragraph (10), as so amended, the following: ‘‘(11) The term ‘person’ includes an affiliate thereof.’’; and (6) by inserting after paragraph (12), as so redesignated, the following: ‘‘(13) The term ‘establishment subject to a registration fee’ means an establishment that is required to register with the Secretary under section 510 and is one of the following types of establishments: ‘‘(A) MANUFACTURER.—An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person. ‘‘(B) SINGLE-USE DEVICE REPROCESSOR.—An establishment that, within the meaning of section 201(ll)(2)(A), performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient. ‘‘(C) SPECIFICATION DEVELOPER.—An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.’’.
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