# Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/custom-device-exemption-guidance-for-industry-and-food-and-drug-administration-staff/5ea0b9ff-f6c9-4da3-99e8-adb1e121faca > FDA guidance document: Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff. Issue date: September 24, 2014. Get complete insights and analysis. --- ## Details - Title: Custom Device Exemption: 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: 2014-09-24 - Last Changed: 2019-02-21 - Docket Number: FDA-2013-D-1601 ## Related Documents - [Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/radiation-biodosimetry-medical-countermeasure-devices-guidance-for-industry-and-food-and-drug-administration-staff/9c7e3c75-b0cc-449b-88ea-9506971780ec) - [Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"): Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/public-notification-of-emerging-postmarket-medical-device-signals-emerging-signals-guidance-for-industry-and-food-and-drug-administration-staff/3b4ae247-9771-40a1-b770-c934376f7835) - [Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-information-for-x-ray-imaging-device-premarket-notifications-guidance-for-industry-and-food-and-drug-administration-staff/7a347f68-87ec-48b0-b385-4a82d1ebd6a3)