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

Name: 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
Creator: Food and Drug Administration
Keywords: 510k,guidances,industry,notification,pre-market,pre-market-notification,substantial

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Published

September 25, 2018

Last updated

October 20, 2020

Description

Guidance document on considering benefit-risk factors for determining substantial equivalence in premarket notifications with different technological characteristics.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

Feedback

Suggest an improvement to this page

1 Main file

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

Updated on October 20, 2020

pdf (537.6KB)

URL: https://www.fda.gov/media/89019/download
Permalink: https://data.openrid.co/en/datasets/r/5d4ad396-7e30-4bb5-a13d-9a48d94b75f9
MIME Type: application/pdf

Created on: September 25, 2018
Modified on: October 20, 2020

Size: 537.6KB

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

Information

Type

Regulated products

Published

Last updated

Description

Tags

Organization

Country / Region

License

Feedback

Actions

Social networks

Embed