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Hello Anon,  Section 513(g) of the FD&C acts is meant for manufacturers to obtain information about the FDA's views regarding the classification of a device. You could get following information from the FDA:           Class of device within that generic type,           PMA, 510(k) or neither is required ...

Hi,  This link may help.  https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee#:~:text=Establishments%20that%20are%20involved%20in,register%20annually%20with%20the%20FDA. ------------------------------ Suraj Maharjan Sr. Regulatory Affairs Specialist ...

This guidance document may be helpful with the requirements: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacement-reagent-and-instrument-family-policy-in-vitro-diagnostic-devices ------------------------------ Suraj Maharjan Sr. Regulatory Affairs Specialist Windham ...

Hi Sara,  You can find information about scoring in RAC candidate guide available in RAPS site. Below is the screenshot from the guide. ------------------------------ Suraj Maharjan Sr. Regulatory Affairs Specialist Windham NH United States ------------------------------

Hi All,  Not very familiar with US FDA Class I devices.  - Some class I device require pre-market notification? What does that include? Is it similar to a 510(k)submission or is it just submitting some performance testing for the device? Any guidance. - Class I exempt device, only needs to be listed ...