510k Performance Testing Studies (Raw Data) - What does the FDA expect

[invitro_spain]

Hello folks,

In the context of a 510(k) and talking about Performance testing Studies, what does the FDA expect, regarding "raw data"?
Original data or the complete traceability from the original data to final results.

Please, some feedback

Thank you in advance

Alberto

 

[Ronen E]

What’s your procode?

Have you consulted section F in here?

 

[invitro_spain]

Thank you for your information, Ronen.

The product is a class II medical device included in the Hematology panel.
Taking into consideration the FDA definition in the 21 CFR 58:

(k) Raw data means any laboratory worksheets, ...original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study.

CFR - Code of Federal Regulations Title 21

I suppose "Raw data" is the original data of one study and the final data will be described in the final report. Is that correct?

 

[yodon]

If you haven't already seen this, you may want to give it a good review: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf (Data Integrity and Compliance With CGMP Guidance for Industry).

 

[Ronen E]

By procode I meant the 3-letter code within the panel.