# Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/intent-to-exempt-certain-unclassified-medical-devices-from-premarket-notification-requirements-guidance-for-industry-and-food-and-drug-administration-staff/ccf098b7-6ec4-43b6-b471-921e6182d902

> FDA guidance document: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements:  Guidance for Industry and Food and Drug Administration Staff. Issue date: February 08, 2019. Get complete insights and analysis.

---

## Details

- Title: Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements:  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: 2019-02-08
- Last Changed: 2019-06-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0967">FDA-2014-D-0967</a>

## Related Documents

- [Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/enforcement-policy-for-non-invasive-remote-monitoring-devices-used-to-support-patient-monitoring-guidance-for-industry-and-food-and-drug-administration-staff/6f2ee667-e678-4e6f-92d0-805b534c457f)
- [General Considerations for Animal Studies Intended to Evaluate Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/general-considerations-for-animal-studies-intended-to-evaluate-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/20618a6e-ba4f-4f65-bbc8-b7b05e3afc90)
- [Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No 57):  Guidance for Industry and Food and Drug Administration](https://www.globalkeysolutions.net/guidances/guidance-document/classification-and-requirements-for-laser-illuminated-projectors-lips-laser-notice-no-57-guidance-for-industry-and-food-and-drug-administration/2b744348-0ec2-49b2-8a01-1267e71cfe8a)