Device Advice All CDRH

Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

Device Advice Site Index

Classification of Medical Devices

• Classify Your Medical Device
• Device Classification Panels
• Device Classes
• Class I/II Exemptions
  
  
• Is the product a Medical Device?
• Device / Not a device
• Contacts for Device / Not a Device Decision

Code of Federal Regulations

Consumer Information

Contact Information

• DSMICA Staff Directory
• Other FDA Components

Exemptions

• 510(k) and GMP Requirements

Export of Medical Devices

• Export of Legally Marketed Devices
• Export Procedures for Unapproved Devices
• Exporting for Investigational Use
• Obtaining Export Certificates
• Importing for Export
• Foreign Liaison List

Help (Device Advice)

• DSMICA Staff Directory
• Overview

Homepage (Device Advice)

Import of Medical Devices

In Vitro Diagnostic Devices

• Labeling

International

• FDA Items of International Interest
• Medical Device International Activities
• International Cooperative Agreements
• Other U.S. Agencies
• Exporting Medical Devices
• Standards Organizations
• Non-U.S. Medical Device Regulators

Investigational Device Exemptions (IDE)

• Introduction
• Approval Process
• Responsibilities
• Application
• Reports
• Records
• Institutional Review Board
• Informed Consent
• Financial Disclosure
• Early/Expanded Access
• Enforcement of GCP
• Import/Export
• F.A.Q's
• Related Topics
• Regulations
• Guidance Documents
• Links

Labeling Requirements

• General
• Over-The-Counter (Non-Prescription) Devices
• Exemptions from Adequate Directions for Use
• Other Labeling Exemptions
• Specific Devices
• Misbranding
• In Vitro Diagnostic Devices
• Quality System Regulation
• Radiation Emitting Devices And Products

Listing of Medical Devices

Manuals

Marketing a Medical Device, How to

Medical Device Reporting (MDR)

Modernization Act of 1997

Overview

Postmarket Surveillance Studies

Premarket Approval (PMA)

• Overview
• Review Process
• PMA Review Fee
• Application Methods
• Application Contents
• Quality System
• Labeling
• Clinical Studies
• Postapproval Requirements
• Supplements and Amendments
• Special Considerations
• Import/Export
• FAQ
• Regulations
• Guidance Documents

Premarket Notification 510(k)

• Introduction
• 510(k) Submission Process
• 510(k) Review Fee
• Exemptions - 510(k) and GMP Requirements
• 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)
• Format of a 510(k)
• Content of a 510(k)
• Is a new 510(k) required for a modification to the device?
• Guidance Documents

Quality System/Good Manufacturing Practices

Recalls (Corrections and Removals)

Registration of an Establishment

Radiation Emitting Products

• Is My Product Regulated by FDA's Center for Devices and Radiological Health?
• Does the product emit radiation?

Regulations

• Code of Federal Regulations

Tracking of Medical Devices

Updated January 13, 2004

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH