# Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/breakthrough-devices-program-guidance-for-industry-and-food-and-drug-administration-staff/615429e8-d815-4bf4-bfc5-68955cba75bb > FDA guidance document: Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff. Issue date: September 14, 2023. Get complete insights and analysis. --- ## Details - Title: Breakthrough Devices Program: 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: 2023-09-14 - Last Changed: 2023-09-14 - Docket Number: FDA-2017-D-5966 ## Related Documents - [Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/computer-software-assurance-for-production-and-quality-system-software-guidance-for-industry-and-food-and-drug-administration-staff/3c846ce6-b6c7-4c31-b809-362db15d032f) - [Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-template-for-medical-device-510k-submissions-guidance-for-industry-and-food-and-drug-administration-staff/e2d20776-7b21-4f34-8478-557a8c57b649) - [Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/safer-technologies-program-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/550343a5-c0c9-44e5-9b3e-333f80238188)