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FDA Approval Process for Medical Devices…

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stervc Member Level  Sunday, 01/09/11 06:58:32 PM
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FDA Approval Process for Medical Devices…

I eventually had gotten through to speak to some of the FDA officials a while back from making a few phone calls. Here’s what I was told in general as I will reference it to the section towards the end titled 510(k) Status Program within the link below:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

FDA approval for a medical device usually takes less than 90 days providing everything is properly done. A company is required to submit a 510(k) application and wait for a response from the FDA officials of either approving the device or informing the company of what is required to be done in order to be granted FDA approval.

Under the 510(k) Status Program, a company is only required to request for an update of the status of their 510(k) application 90 days after their initial log-in.

After such, the company can only request status reports every 30 days following the initial status request. A status report is received by filling out the status request form, FDA 354114, and then faxing it to the CDRH office identified on the form. Then within three working days after a status request is received, CDRH will send the company a fax that includes the last action taken on their submission and all other pertinent information.

v/r
Sterling


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