Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff

Name: Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: 510k,draft,guidances,industry,notification,practices,pre-market,pre-market-notification,submissions,support

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Premarket

Published

September 7, 2023

Last updated

September 6, 2023

Description

A draft guidance document providing best practices for selecting a predicate device to support a premarket notification submission.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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1 Main file

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff

Updated on September 6, 2023

pdf (593.3KB)

URL: https://www.fda.gov/media/171838/download
Permalink: https://data.openrid.co/en/datasets/r/a013f932-6a76-41c6-890d-9f1a046fe6a0
MIME Type: application/pdf

Created on: September 7, 2023
Modified on: September 6, 2023

Size: 593.3KB

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff

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Regulated products

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Published

Last updated

Description

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