Examples of CLIA Waiver in a sentence
The Clinical Laboratory Improvement Amendment (CLIA) of 1988 requires laboratories and other facilities that test human specimens to obtain either a CLIA Waiver or CLIA Certificate in order to obtain reimbursement from the Medicare and Medicaid (AHCCCS) programs.
Industry will inform FDA that it plans to submit a dual submission (510(k) and CLIA Waiver application) during the Pre-Submission process.
FDA Days are those calendar days when a submission is considered to be under review at the Agency for submissions that have been accepted (510(k) or De Novo request), filed (PMA) or submitted (CLIA Waiver by application).
During the pre-submission process, if the applicant informs FDA that it plans to submit a dual submission (510(k) and CLIA Waiver application), FDA will issue a decision for 90% of such applications within 210 FDA days.
Applicant means a person who makes any of the following submissions to FDA: • an application for premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (FD&C Act);• a premarket notification under section 510(k) of the FD&C Act;• an application for investigational device exemption under section 520(g) of the FD&C Act;• a Pre-Submission;• a De Novo classification request (De Novo request) under section 513(f)(2) of the FD&C Act;• a CLIA Waiver by application.
Pre-Submission review timeframes in Section II.A apply to Pre-Submissions for CLIA Waiver by Application and Dual submission 510(k)/CLIA Waiver applications.
CLIA Waiver by Application Submissions: Decisions for CLIA Waiver by Application Submissions are approval, withdrawal, and denial.
To obtain a CLIA Certificate of Waiver, organizations must complete an application (CLIA Waiver Application Form) and upon approval will be invoiced a $180 fee.
To assess the performance of the Click device for detection of CT, NG, and TV in self-collected vaginal specimens as compared to PIS determined by three approved comparator assays using vaginal specimens collected by a qualified HCP in support of obtaining FDA clearance and a Clinical Laboratory Improvement Amendments (CLIA) Waiver.
A sponsor or applicant may request a Submission Issue Meeting to discuss deficiencies identified during premarket review of a 510(k), de novo, IDE, HDE, PMA, IND or BLA application or CLIA Waiver by Application, including associated amendments or supplements, whether these deficiencies were communicated in writing (e.g., additional information, major deficiency, or not approvable letter) or through email, telephone, or fax (e.g., telephone hold).