Regulatory Problems

Moderators:Eugene Chen and

Michael Kochman, MD

IRB

• No shopping• Non-approved use– Local use or trial– Industry marketing claims

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

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

Pathways

• PMA – Clinical trials

• 510-K (predicate device)– Starting to ask for clinical data• Safety• Efficacy

– new issue

510(k)

• Letter to file– Minor change documentation

• Special• Standard

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

Non-US

• Canada• Japan

International Cross-Talk

• Details lacking in published studies– Useless for FDA purposes

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

MD

• Lack of clear understanding• Confusion re: label indications

Pathways

• 510(k)– Tools– Endoscopy

• PMA ($90 million US or so)– Implants– May have a formal reclassification to

predicate device

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

Degree of Impact on Adoption of NOTES®

• Significant– Slow-down– Non-US development

Source of Problem

• Non-statute interpretation of regulation

• Claims

Parties Affected

• Physicians• Industry• Patients

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

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

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