# Adaptive Designs for Medical Device Clinical Studies:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/adaptive-designs-for-medical-device-clinical-studies-guidance-for-industry-and-food-and-drug-administration-staff/70eec6c8-49d6-475b-8538-2f4e934cf72b

> FDA guidance document: Adaptive Designs for Medical Device Clinical Studies:  Guidance for Industry and Food and Drug Administration Staff. Issue date: July 27, 2016. Get complete insights and analysis.

---

## Details

- Title: Adaptive Designs for Medical Device Clinical 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: 2016-07-27
- Last Changed: 2020-10-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-1439">FDA-2015-D-1439</a>

## Related Documents

- [eCopy Program for Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/ecopy-program-for-medical-device-submissions-guidance-for-industry-and-food-and-drug-administration-staff/8d87a1c4-b362-4f01-bdca-28f730b7f5f0)
- [Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/radio-frequency-wireless-technology-in-medical-devices-guidance-for-industry-and-fda-staff/a01cd2bb-faeb-44da-958b-c7ba3142c277)
- [Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/balancing-premarket-and-postmarket-data-collection-for-devices-subject-to-premarket-approval-guidance-for-industry-and-food-and-drug-administration-staff/0be21e15-5c88-436c-9ca5-5746e509f79c)
