Invitro device and 510K related information resource

- Medical Device Guidance Documents - [http://www.fda.gov/cdrh/guidance.html ]
- CDRH Databases - [http://www.fda.gov/cdrh/databases.html ]
- Code of Federal Regulations - [http://www.fda.gov/cdrh/devadvice/365.html ]
- International Information - [http://www.fda.gov/cdrh/international/ ]
- Consumer Information - [http://www.fda.gov/cdrh/consumer/index.html ]
- Overview of Regulations - http://www.fda.gov/cdrh/devadvice/overview.html
- Is Your Product Regulated? - http://www.fda.gov/cdrh/devadvice/31.html
- Classify Your Medical Device - http://www.fda.gov/cdrh/devadvice/313.html
- How to Market Your Medical Device - http://www.fda.gov/cdrh/devadvice/3122.html
- Does Your Product Emit Radiation? - http://www.fda.gov/cdrh/devadvice/311.html
- Registering Your Establishment -http://www.fda.gov/cdrh/devadvice/341.html
- Listing Your Medical Device -http://www.fda.gov/cdrh/devadvice/342.html
- PMN = Premarket Notification 510(k) -http://www.fda.gov/cdrh/devadvice/314.html
- Device Exemptions 510(k) but with GMP - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
- Investigational Device Exemption (IDE) http://www.fda.gov/cdrh/devadvice/ide/index.shtml - Premarket Approval (PMA) Class III Devices http://www.fda.gov/cdrh/devadvice/pma/
- Quality System (QS) Regulation for Good Manufacturing Practices (GMP) http://www.fda.gov/cdrh/devadvice/32.html
- Device Labeling Requirements http://www.fda.gov/cdrh/devadvice/31.html
- Medical Device Reporting (MDR) http://www.fda.gov/cdrh/devadvice/351.html
- Device Recalls Corrections Removals http://www.fda.gov/cdrh/devadvice/51.html
- Importing Medical Devices into the U.S. http://www.fda.gov/cdrh/devadvice/391.html
- Exporting Medical Devices from the U.S. http://www.fda.gov/cdrh/devadvice/39.html