Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

Name: Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)
Creator: Food and Drug Administration
Keywords: 510k,cdrh,center-for-devices-and-radiological-health,guidances,intended-use,pre-market,updates

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

December 2, 2002

Last updated

March 19, 2020

Description

This document is a guidance for CDRH staff on determining the intended use for 510(k) devices in the premarket stage.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

Updated on March 19, 2020

pdf (275.0KB)

URL: https://www.fda.gov/media/72446/download
Permalink: https://data.openrid.co/en/datasets/r/4b90a03b-b788-44a5-9bd7-fd44a227d8c6
MIME Type: application/pdf

Created on: December 2, 2002
Modified on: March 19, 2020

Size: 275.0KB

Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

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Regulated products

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Published

Last updated

Description

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