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Clia Certificate Of Waiver Form: What You Should Know
Complete the Application for a CIA Certificate of Waiver, form FDA-HFS-02, and the CIA Certificate of Authorization, form FDA-HFS-05, prior to submitting it to FDA. The information submitted to FDA with the application must include the facility's name and address, the facility's location (state or country), and a summary of applicable lab activities at the location. FDA requires each laboratory that obtains an FDA Certificate of Waiver with the agency to maintain detailed records of the following: The results obtained through the application process with the agency; the laboratory activities performed at the facility and its location; and The laboratory activities performed on the basis of the laboratory certificate, certified by the FDA to have been completed prior to submission to FDA. Note: In some instances, as is the case with the National Institutes of Health (NIH), a facility may receive a CIA Certificate of Waiver if it is the single testing laboratory that has been chosen during the waiver application process, and is the principal testing laboratory where the laboratory's principal testing activity must be performed. An applicant may request a CIA Certificate of Waiver by submitting a statement to FDA with supporting documentation as determined by FDA. The applicant must submit the documents to FDA for review prior to the approval of the application. How to apply for a CIA Certificate of Waiver via In.gov or the FOIA — CIA In addition to requiring the application to be accompanied by documentation, FDA also requires that the supporting documents be retained for 20 years following the date of application. If an applicant does not submit the following: Form FDA-HFS-09, which is used in the case of a FOIA request; A certification of certification issued by an appropriate Federal unit authorized to accept and process applications for a medical examiner certificate, or a certificate of certification issued by an appropriate State entity; or Evidence of a previous submission to FDA for a medical examiner certificate for a location where the activity required by the CIA certificate is being performed as shown in an annual summary published by FDA (the facility must have conducted an application review prior to that time to qualify for approval) See also FDA's requirements for the FDA-provided certificate of Waiver (the certificate itself does not require FDA approval). How to obtain a CIA Certificate of Waiver — FDA For facilities that wish to obtain a CIA certificate of waiver by submitting a request for a CIA review of the facility's application, please review these two FDA Frequently Asked Questions (FAQs).
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