510(k) Basics
General Information
Background - Federal Register
Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Final rule (pdf)
Medical devices; exemptions from premarket notification; class II devices--FDA
Federal Register: Medical Devices; Substantial Equivalence; 510(K) Summaries and 510(K) Statements; Class III Summaries; Confidentiality of Information - Final Rule, 1994
Medical devices; exemptions from premarket notification; class II devices--FDA
Federal Register: Medical Devices; Substantial Equivalence; 510(K) Summaries and 510(K) Statements; Class III Summaries; Confidentiality of Information - Final Rule, 1994
Device Regulation
Overview of Device Regulation
How to Market Your Device
Postmarket Requirements (Medical Devices)
510(k) Clearances
Required Submission of Safety and Effectiveness Information for Certain Class III Devices
Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submission
View on FDA’s “Intended Use” and “Indications for Use”
Emergo Group: How to obtain regulatory approval for a medical device from the US FDA (pdf)
How to Market Your Device
Postmarket Requirements (Medical Devices)
510(k) Clearances
Required Submission of Safety and Effectiveness Information for Certain Class III Devices
Screening Checklist for Traditional/Abbreviated Premarket Notification [510(k)] Submission
View on FDA’s “Intended Use” and “Indications for Use”
Emergo Group: How to obtain regulatory approval for a medical device from the US FDA (pdf)
Review Process
Third Party Review
UL's FDA Third Party 510(k) Tool Kit (pdf)
Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
UL's FDA Third Party 510(k) Tool Kit (pdf)
Current List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
510(k) Flowcharts
510(k) “Substantial Equivalence” Decision Making Process
Flowchart from Clinical Solutions International, LLC (pdf)
Flowchart from Clinical Solutions International, LLC (pdf)
Submission Process
Premarket Notification (510(k)
Premarket Notification (510k): Overview
510(k) Submission Process
510(k) Forms
510(k) Submission Methods
510(k) Exempt Devices
Premarket Notification [510(k)] Review Fees
How To Find A Predicate Device
How To Prepare A Traditional 510(k)
How To Prepare A Special 510(k)
How To Prepare an Abbreviated 510(k)
Is a new 510(k) required for a modification to the device?
Special Considerations
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
Device Registration and Listing
510(k) Submission Process
510(k) Forms
510(k) Submission Methods
510(k) Exempt Devices
Premarket Notification [510(k)] Review Fees
How To Find A Predicate Device
How To Prepare A Traditional 510(k)
How To Prepare A Special 510(k)
How To Prepare an Abbreviated 510(k)
Is a new 510(k) required for a modification to the device?
Special Considerations
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
Device Registration and Listing