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40 C.F.R. § 610.16

Applicant's responsibilities.

§ 610.16 Applicant's responsibilities.

Each applicant for evaluation under § 610.12(c) will be responsible for the following:

(a) Submission of an application, in the format specified by the Administrator, prior to initiation of the evaluation. A separate application shall be made for each different device. The application shall be made to the Administrator (or his delegate) by the manufacturer and shall be updated and corrected by amendment if deemed necessary by EPA.

(b) The application shall be in writing, signed by an authorized representative of the manufacturer, and shall include the following:

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The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

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