I don't think designing a clinical study without the involvement of a qualified biostatistician is ever a good plan.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 19-Jan-2017 06:20
From: Noemi Olivo
Subject: IVD performance study for 510(k)
Thank you Paul; great advice. I'm currently working on the Pre-Sub with hopes to submit by end of this month.
Here's another question, if you don't mind: I am working on the final drafts of the proposed study protocol for the Pre-Sub and wondering if the FDA reviewers will be looking for a "complete" statistical plan - I have included a section with what amounts to an outline of the requirements, but since we don't have a statistician, yet, it's not a concise plan. My company is a small start-up with limited resources and does not want to contract a statistician until the "final" performance studies protocol is being written for the 510(k) performance studies. Is this not a good plan?
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Noemi Olivo
Milford CT
United States
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Original Message:
Sent: 18-Jan-2017 11:52
From: Paul Swift
Subject: IVD performance study for 510(k)
The answer, as is often the case, is "it depends." There area number of considerations:
- Were they complying with a guidance document or recognized standard?
- Was the study powered to demonstrate a certain endpoint?
- Has your team come up with a different, scientifically valid, number that you think is appropriate?
- When was your predicate cleared? Has the Agency's thinking in the area changed over time?
- Do you have the same scientific technology, operating principles, etc.?
The safest route, of course, is to submit a pre-sub.
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Paul Swift, RAC
Director, Global RA
Fort Worth, TX
United States
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Original Message:
Sent: 16-Jan-2017 13:36
From: Noemi Olivo
Subject: IVD performance study for 510(k)
Does the performance study to evaluate our IVD's analytical and clinical performance characteristics for our 510(k) submission have to include the same of study sites and number of subjects as our chosen predicate?
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Noemi Olivo
Milford CT
United States
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