# The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program:  Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/the-accreditation-scheme-for-conformity-assessment-asca-pilot-program-guidance-for-industry-accreditation-bodies-testing-laboratories-and-food-and-drug-administration-staff/92e0773c-84a0-4cf7-a1a0-23e3e974cddc

> FDA guidance document: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program:  Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff. Issue date: September 25, 2020. Get complete insights and analysis.

---

## Details

- Title: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program:  Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2020-09-25
- Last Changed: 2024-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-3805">FDA-2019-D-3805</a>

## Related Documents

- [Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program:  Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/biocompatibility-testing-of-medical-devices-standards-specific-information-for-the-accreditation-scheme-for-conformity-assessment-asca-pilot-program-guidance-for-industry-accreditation-bodies-testing-laboratories-and-food-and-drug-administration-staff/f9570649-5fcb-461f-b67b-e49948ba906e)
- [Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program:  Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/basic-safety-and-essential-performance-of-medical-electrical-equipment-medical-electrical-systems-and-laboratory-medical-equipment-standards-specific-information-for-the-accreditation-scheme-for-conformity-assessment-asca-pilot-program-guidance-for-industry-accreditation-bodies-testing-laboratories-and-food-and-drug-administration-staff/f849c680-dd31-4f2b-ae1a-e6f8ffcf1424)
- [The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/the-accreditation-scheme-for-conformity-assessment-asca-program-draft-guidance-for-industry-accreditation-bodies-testing-laboratories-and-food-and-drug-administration-staff/a58de170-810e-44d6-91f6-f08acf3dcaf9)
