regulatory problems moderators: eugene chen and michael kochman, md
TRANSCRIPT
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Regulatory Problems
Moderators:Eugene Chen and
Michael Kochman, MD
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IRB
• No shopping• Non-approved use– Local use or trial– Industry marketing claims
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Pathways
• Humanitarian Device Exemption– Less than 10,000 patients• Recoup R&D in US
– OK for non-US profit
• Requires IRB approval• Retrospective data analysis allowed
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IDE
• No FDA approval needed for clinical trial• Significant risk vs. Non-significant risk– If IRB determines significant risk, then FDA approval
required • Likely path for NOTES®– Exemption to allow for clinical use– Requires clinical trial
• End-points defined• Outcomes• If primary end-point fails, trial redo required
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Pathways
• PMA – Clinical trials
• 510-K (predicate device)– Starting to ask for clinical data• Safety• Efficacy
– new issue
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510(k)
• Letter to file– Minor change documentation
• Special• Standard
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Non-US
• CE– Industry migration to Europe– Individual device use if made in-house with IRB– Industry or multicenter requires exclusion to CE• Individual can obtain CE (similar to 510(k))• ISO 9001 equivalent – independent body certifies
adherence to standards– (balloons would require PMA, but CE approved)– Device authorities vary by country as far as sales– EU notified body
» 72 days
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Non-US
• Canada• Japan
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International Cross-Talk
• Details lacking in published studies– Useless for FDA purposes
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FDA
• Branches– Regulatory– Compliance/enforcement• Question studies sponsored for non-label indications
• Concerns re: hidden specific indications• Black-box “not indicated for…” eliminating
“hidden specific” indications• External reviewers
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MD
• Lack of clear understanding• Confusion re: label indications
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Pathways
• 510(k)– Tools– Endoscopy
• PMA ($90 million US or so)– Implants– May have a formal reclassification to
predicate device
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Current Issues• Pathways not clear– What makes a 510(k) or a PMA not uniform– Surgical branch and GI/GU branch
• NOTES and obesity are going to GI/GU and asked to be PMA• Industry has tried 510(k) sneaks• International differences• Broad claims vs. specific claims– Revenue and marketing issues
• Innovation in US stifled by process and regulation– Leadership lost– Economic impact
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Degree of Impact on Adoption of NOTES®
• Significant– Slow-down– Non-US development
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Source of Problem
• Non-statute interpretation of regulation
• Claims
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Parties Affected
• Physicians• Industry• Patients
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NOSCAR®• Taking device forward is difficult for professional
societies– Can we take and obtain device approval as a retractor for
TV chole?• Support 510(k) for a company and device
• Different access site is viewed as PMA– NOSCAR to go forward saying FDA cannot regulate
surgical/clinical practice• Position statement on safety– Transvaginal access statement needed– Trochar placement irrelevant
• Eliminate statement on registry
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Priorities• FDA pathways in US need clear definition and
alignment– Engagement on multiple levels – One group to handle space– Likely congressional engagement
• International homologation– Studies not informative, ergo, not useful in current
iterations
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Priorities (cont.)• Professional society interaction– May be best to avoid industry queries on record– Need to push back on regulation of procedures
• Access site, target (including endoluminal) not in purview of FDA
– Regulatory strategy alignment• Reiterate corporate mission support
– Guideline statement on transvaginal (TV) access as accepted clinical use• TV cholecystectomy as accepted
– Guideline statement on flexible endoscope use in peritoneal cavity is accepted clinical use