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Guidance Documents: UNITED STATES

REGULATORY GUIDANCE DOCUMENTS

The FDA website for medical devices is located at this address: http://www.fda.gov/MedicalDevices/default.htm.

A searchable listing of device-related guidance document is available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

Guidance on medical device registration and listing requirements can be found on this web page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm.

An explanation of the processes available for making a medical device available on the US market is available from here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm.

An explanation of the requirement for a ‘US Agent’ can be found at this web address: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm.

The FDA Center for Devices and Radiological Health (CDRH) has many publicly available and searchable databases, listed on this web page: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm.

CDRH recognises many internatioanl consensus standards, and these can be found from this search web page: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

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