# Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-for-medical-devices-in-electronic-format-submissions-under-section-745ab-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry-and-food-and-drug-administration-staff/fc3853a4-7287-48ef-a363-32e3dfef666c

> FDA guidance document: Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act:  Guidance for Industry and Food and Drug Administration Staff. Issue date: July 15, 2020. Get complete insights and analysis.

---

## Details

- Title: Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act:  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: 2020-07-15
- Last Changed: 2020-07-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-3769">FDA-2019-D-3769</a>

## 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 De Novo Requests:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-template-for-medical-device-de-novo-requests-guidance-for-industry-and-food-and-drug-administration-staff/8bd49234-647d-4582-b2b5-adc2a5d75f1c)
- [Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/referencing-the-definition-of-device-in-the-federal-food-drug-and-cosmetic-act-in-guidance-regulatory-documents-communications-and-other-public-documents-guidance-for-industry-and-food-and-drug-administration-staff/d129e237-573b-4154-b731-0db0644370be)