Meenakshi,
There is no specified format that can be observed in the Format of a 510(k) from the FDA's website. However, for Section 20 - Performance Testing - Clinical refer to any specified guidance documents based on the product type. Also refer to ISO 14155 for content of clinical investigations/trials. Usually in Section 20 I provide a summary of the protocol, trial conduct, and summary of the trial. Then there are references to the clinical protocol and clinical report as an Exhibit. There are lots of different ways to put this together, but the actual section just needs to include enough content describing what was done with all the detail in the clinical report. Also note that if you have Performance Testing - Clinical this also needs to be included in the 510(k) Summary - and reviewers are getting quite picky that this needs to include sufficient information.
------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 22-Jan-2019 11:39
From: Meenakshi Verma
Subject: 510k - Performance testing-Clinical section
Hi Guys,
For the purpose of a traditional 510k submission - Is there any FDA guidance document which provides insight on what to include in the Performance testing - Clinical section of the 510k?
Thanks in advance!
Meenakshi
------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------