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CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements
ICR 202606-0910-007 · OMB 0910-0889 · Object 170617000.
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Document Metadata
| File Type | application/pdf |
|---|---|
| File Title | CDRH Accreditation Scheme for Conformity Assessment: reporting; recordkeeping; and disclosure elements |
| File Modified | 2023-05-15 |
| File Created | 2023-01-25 |
| Conversion State | complete |
Extracted Text
Mockups for a Testing Lab’s CCP-ASCA webform Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Accreditation ! Basic information Scope of accreditation Files and documents Review & send to FDA Basic info Laboratory info Testing laboratory name Acronym for testing laboratory (optional) Address line 1 Address line 2 (optional) City State (US) ZIP/Postal code " Country Province/region (optional) " Business phone number Website URL (optional) Point(s) of contact Primary Point of Contact First Name Anthony Last name Fauci Title (optional) Phone number Email address [email protected] Add more Cancel Next Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Accreditation " Basic information Scope of accreditation Files and documents Review & send to FDA Scope of accreditation Accreditation body ANSI National Accreditation Board (ANAB) ! Consensus standards Remove Cancel Add another accreditation body Next Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Accreditation ! Basic Information Scope of accreditation Files and documents Review & send to FDA Files and documents Information demonstrating ability to participate in the ASCA pilot (i.e., supporting document[s] demonstrating competency) " Drag & drop your document(s) here, or browse for it Back Next Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Accreditation ! Basic Information Scope of accreditation Files and documents Review & send to FDA Basic Information " Laboratory details ABC Testing Laboratory, Inc. Acronym: ABC 123 Main Street Fresno, California 12345 United States +1-234-432-4224 https://www.abctestinglab.com Point(s) of contact Anthony Fauci Test Manager +1-222-222-2222 [email protected] Eric Lucci Tester +1-222-222-2222 [email protected] Scope of accreditation " AL2A Files and documents " Letter(s) from one or more accreditation bodies stating your prequalifications: ! PrequalLetterfromAB.pdf Additional supporting document(s) demonstrating competency: ! Medtronics_nonIVD_Syringe.pdf By submitting, you are agreeing with the terms of participation described in Section D of Appendix B of the ASCA Pilot program guidance document. Back Submit Mockups for an Accreditation Body’s CCP-ASCA webform Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Recognition ! Basic information Scope of accreditation Files and documents Review & send to FDA Basic info Accreditation body Accreditation body name Acronym for accreditation body (optional) Address line 1 Address line 2 (optional) City State (US) " Business phone number Website URL (optional) Point(s) of contact Primary Point of Contact First Name Marie Last name Curie Title (optional) Phone number Email address [email protected] Add more Cancel Next ZIP/Postal code Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Recognition ! Basic information Scope of accreditation Files and documents Review & send to FDA Scope of accreditation Select all that apply Back Next Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Recognition ! Basic Information Scope of accreditation Files and documents Review & send to FDA Files and documents Supporting document(s) demonstrating ability to participate in the ASCA pilot (i.e., information in support of competence): " Drag & drop your supporting documents here, or browse for it Back Next Decision Management Customer CollaborationPortal Portal Send a submission https:// dmp.aws.com Apply for ASCA Recognition ! Basic Information Scope of accreditation Files and documents Review & send to FDA Basic Information " Accreditation body details New Accreditation Body, Inc. Acronym: NAB 123 Main Street Fresno, California 12345 United States +1-234-432-4224 https://www.NAB.com Point(s) of contact Marie Curie Test Manager +1-222-222-2222 [email protected] Nels Anderson Tester +1-222-222-2222 [email protected] Scope of accreditation " Files and documents " Supporting document(s) demonstrating competency: ! Competency.pdf ! Additional_Data_here.xls By submitting, you are agreeing with the terms of participation described in Section D of Appendix A of the ASCA Pilot program guidance document. Back Submit