OMB control number
Accreditation Scheme for Conformity Assessment Program
OMB 0910-0889 · HHS/FDA.
OMB 0910-0889
This information collection helps support implementation of sections 514 and 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d and 360d(d)) which provide for the establishment of performance standards and authorizes the Accreditation Scheme for Conformity Assessment Program (ASCA Program). The ASCA program allows testing laboratories to be accredited by ASCA-recognized accreditation bodies to assess the conformance of a device to certain FDA-recognized standards.
The latest form for Accreditation Scheme for Conformity Assessment Program expires 2026-08-31 and is listed under ICR 202212-0910-012.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0889 CDRH Conformity Assessment SSA 2023 REV.docx | Supporting Statement A |
| 0889 and 0120 eSTAR Change Request SEPT 2021 Final.docx (document unavailable) | Justification for No Material/Nonsubstantive Change |
 CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements |
Other-Agency Guidance |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202212-0910-012 | Extension without change of a currently approved collection | 2023-06-30 | Approved without change | |
| 202109-0910-002 | No material or nonsubstantive change to a currently approved collection | 2021-09-10 | Approved without change | |
| 202002-0910-010 | New collection (Request for a new OMB Control Number) | 2020-05-01 | Approved with change |