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40 C.F.R. § 1060.210

What records should equipment manufacturers keep if they do not apply for certification?

§ 1060.210 What records should equipment manufacturers keep if they do not apply for certification?

If you are an equipment manufacturer that does not need to obtain a certificate of conformity for your equipment as described in § 1060.5, you must keep the records specified in this section to document compliance with applicable requirements. We may review these records at any time. If we ask, you must send us these records within 30 days. You must keep these records for eight years from the end of the model year.

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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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