OIVD: Parting Shots, IVD Roundtable 510(k) Workshop

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Parting Shots
IVD Roundtable 510(k) Workshop

Steven I. Gutman, MD, MBA
Director
Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Workshop

Product of the Industry IVD Round Table
Good submissions are easy to review
Good submissions are fast to review
Bad submissions gum up the works

Clear Pathways

Workshop
Guidances
Standards
Articles
Posting submissions

Three Kinds of Expertise

Regulatory acumen
Scientific acumen
Statistical acumen
In-house
Contract

FDA

Sound science
Least burdensome
Plain English
Ask for the same
Don’t assume

Companies Can

Do a good job
Quality control their work
Use correct expertise

Common Deficiencies

Unclear intended use
Failure to link data to use
Poor design -- lack of correlation to claim
Failure to clarify how data generated and analyzed
Insufficient data

Words of Advice

Survey the field
Make good choices
Don’t assume more is more
Utilize Pre-IDE process
Bring in experts
Don’t be afraid to question, appeal

Updated 5/20/2003

horizonal rule

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