OMB control number
CLIA Waiver Applications
OMB 0910-0598 ยท HHS/FDA.
OMB 0910-0598
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests that are "so simple and accurate as to render the likelihood of erroneous results negligible" may obtain a certificate of waiver. The Secretary delegated to FDA the authority to determine under CLIA whether particular tests (waived tests) are "simple" and have "an insignificant risk of an erroneous result". Device manufacturers will submit to FDA an application for determination that a cleared or approved device meets this CLIA standard (CLIA waiver application).
The latest form for CLIA Waiver Applications expires 2022-09-30 and is listed under ICR 201908-0910-008.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0598_Supporting Statement_2019.doc | Supporting Statement A |
 Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 201908-0910-008 | Extension without change of a currently approved collection | 2019-08-16 | Approved without change | |
| 201606-0910-007 | Extension without change of a currently approved collection | 2016-07-20 | Approved without change | |
| 201304-0910-004 | Extension without change of a currently approved collection | 2013-04-23 | Approved without change | |
| 201002-0910-003 | Extension without change of a currently approved collection | 2010-02-16 | Approved without change | |
| 200611-0910-010 | New collection (Request for a new OMB Control Number) | 2006-11-30 | Approved with change |