# Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/medical-devices-and-clinical-trial-design-for-the-treatment-or-improvement-in-the-appearance-of-fungally-infected-nails-guidance-for-industry-and-food-and-drug-administration-staff/85b69c73-53d8-4a3a-9f25-58dad5f243b9

> FDA guidance document: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails:  Guidance for Industry and Food and Drug Administration Staff. Issue date: March 07, 2016. Get complete insights and analysis.

---

## Details

- Title: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails:  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: 2016-03-07
- Last Changed: 2019-02-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-1849">FDA-2014-D-1849</a>

## Related Documents

- [Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/labeling-for-permanent-hysteroscopically-placed-tubal-implants-intended-for-sterilization-guidance-for-industry-and-food-and-drug-administration-staff/90c1f1b9-1a53-417f-8d58-7605e596a3a6)
- [Reporting of Computational Modeling Studies in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/reporting-of-computational-modeling-studies-in-medical-device-submissions-guidance-for-industry-and-food-and-drug-administration-staff/422a1a1e-f32d-4df7-a042-f1af0d663768)
- [Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/premarket-notification-510k-submissions-for-bipolar-electrosurgical-vessel-sealers-for-general-surgery-guidance-for-industry-and-food-and-drug-administration-staff/1a366393-d345-405a-a360-ebf32c15bbc9)
