Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'm getting conflicting information in the UK.  Does the 510k need to be filed and approved prior to registering facility with FDA or do I need to register the company with FDA prior to submitting the 510k?

Thank you for your insight.

FDA: "...If your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device..."  See https://www.fda.gov/medical-devices/device-registration-and-listing/when-register-and-list 

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Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 19-Aug-2021 09:24
From: Anonymous Member
Subject: Acquired company in UK – Need to FDA register and submit 510K

This message was posted by a user wishing to remain anonymous

I'm getting conflicting information in the UK.  Does the 510k need to be filed and approved prior to registering facility with FDA or do I need to register the company with FDA prior to submitting the 510k?

Thank you for your insight.