# Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/benefit-risk-factors-to-consider-when-determining-substantial-equivalence-in-premarket-notifications-510k-with-different-technological-characteristics-guidance-for-industry-and-food-and-drug-administration-staff/9b4259f7-7bc8-42ed-aa66-3fd197961ad3

> FDA guidance document: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 25, 2018. Get complete insights and analysis.

---

## Details

- Title: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics:  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: 2018-09-25
- Last Changed: 2020-10-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0900">FDA-2014-D-0900</a>

## Related Documents

- [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)
- [Deciding When to Submit a 510(k) for a Software Change to an Existing Device:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/deciding-when-to-submit-a-510k-for-a-software-change-to-an-existing-device-guidance-for-industry-and-food-and-drug-administration-staff/303c36a0-3191-4197-bc16-584e24525d07)
- [Breakthrough Devices Program:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/breakthrough-devices-program-guidance-for-industry-and-food-and-drug-administration-staff/615429e8-d815-4bf4-bfc5-68955cba75bb)