Code of Federal Regulations · Section

§ 1.1140 — What Must A Laaf-accredited Laboratory Do To Voluntarily Relinquish Its Laaf-accreditation?

21 C.F.R. § 1.1140

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(a) Notice to FDA and the recognized accreditation body of intent to relinquish. A LAAF-accredited laboratory must notify FDA and its recognized accreditation body at least 60 calendar days before voluntarily relinquishing LAAF-accreditation or any method within the scope of LAAF-accreditation. The notice must include the date on which relinquishment will occur. If the laboratory will relinquish all methods within its scope of LAAF-accreditation, the notification must also include the name and contact information of the custodian who will maintain the records required by § 1.1154 after the date of relinquishment. The contact information for the records custodian must include an email address and the street address where the records required by § 1.1154 will be located.

(b) Public notice of voluntary relinquishment of accreditation. FDA will provide notice on the website described in § 1.1109 of the voluntary relinquishment of LAAF-accreditation of a laboratory.

Authorizing Statute