Useful FDA website links and other resources

Here are some websites that you may find to be useful, including several links within the huge FDA website that pertain to medical devices.

US Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH) – Home page of division within FDA that oversees devices.
CDRH Guidance Document Search – Online tool that allows you to find FDA guidance documents for devices.
FDA Medical Device Classification Database – Determine classification, product code and find predicate devices.
FDA 510k Database – Search for cleared devices by 510k number, device name, company name, product code, etc.
Third Party Review -Devices that qualify for expedited third party 510k review and companies perform this service.
FDA Establishment Registration & Device Listing database – Search for companies to see if they are registered with the FDA.
FDA Fees – Shows all the fees the FDA charges for 510k review, registration, small businesses and more.
FDA Payment Process - Information on accepted forms of payment and link to Device Facility User Fee website.
FDA Registration – Information on the FDA company registration process, with links to the online registration system.

EmergoGroup.com - Medical device QA and RA consultants

EmergoJapan.co.jp – 薬事コンサルティングサービスのご案内

EmergoFrance.fr – Consultants Internationaux en Dispositifs Médicaux

EmergoGroup.de – Internationale Berater für medizinische Produkte und IVD

ISO13485.com - ISO 13485 quality system consulting, auditing and training

Medical-Distributors.com – International medical device distributor search consultants

GreenDotCompliance.eu – Green Dot consulting for compliance with the European Packaging Waste Directive