# Recommendations for Dual 510(k) and CLIA Waiver by Application Studies:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-dual-510k-and-clia-waiver-by-application-studies-guidance-for-industry-and-food-and-drug-administration-staff/02a7cfc8-9402-4ce9-89ca-2983b8cd9092

> FDA guidance document: Recommendations for Dual 510(k) and CLIA Waiver by Application Studies:  Guidance for Industry and Food and Drug Administration Staff. Issue date: February 26, 2020. Get complete insights and analysis.

---

## Details

- Title: Recommendations for Dual 510(k) and CLIA Waiver by Application Studies:  Guidance for Industry 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: 2020-02-26
- Last Changed: 2021-01-26
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2017-D-5625">FDA-2017-D-5625</a>

## Related Documents

- [Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/technical-performance-assessment-of-quantitative-imaging-in-radiological-device-premarket-submissions-guidance-for-industry-and-food-and-drug-administration-staff/0ad9d5da-55b8-46ee-b2ab-37dd0c4b75b2)
- [Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/classification-of-posterior-cervical-screw-systems-small-entity-compliance-guide-guidance-for-industry-and-food-and-drug-administration-staff/b2125432-cdef-4b27-b814-93f95d941c9c)
- [Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/spinal-plating-systems-performance-criteria-for-safety-and-performance-based-pathway-guidance-for-industry-and-food-and-drug-administration-staff/9b6099f2-dd3d-40cb-b1b5-5db32066311a)