Medical Device Maintenance and Sources of Obtaining Medical Device- Related Failure Data
Medical Device User Fee Reauthorization & FDA Update Roadmap to a Successful 510(K) Submission For...
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Transcript of Medical Device User Fee Reauthorization & FDA Update Roadmap to a Successful 510(K) Submission For...
Medical Device User Fee Reauthorization & FDA
Update
Roadmap to a Successful 510(K) Submission For Your Medical Device
August 22, 2012
AGENDA• How Did We Got Here?• Device User Fee Renewal• FDA Regulatory Environment
510(k) review times have risen 46% since 2007 as approval volume has trended down
User Fee Reauthorization: 510(k) Performance Improvements
• Decision made within 90 (FDA) Days– 2013: 91% of submissions– 2014: 94%– 2015: 95%
• Avg total time to decision in calendar days– 2013 submissions: 135 days– 2015 submissions: 130 days– 2017 submissions: 124 days
User Fee Reauthorization: Regulatory Process Reforms
• Communications/Interaction Improvements– Pre-Submission meetings– Midway review feedback (60 day from submission
for 510(k)s)– Documentation/Review of Agency decisions• Submitter may request supervisory review within 30
days of decision
User Fee Reauthorization: Regulatory Process Reforms
• IDE Standard – Agency cannot disapprove IDEs because the investigation does not:(1) support a substantial equivalence or de novo
determination or approval(2) may not meet any requirement (including data
requirement)(3) additional or different investigations may be
necessary to support clearance or approval of the device.
User Fee Reauthorization: Regulatory Process Reforms
• 510(k) Modifications:– Agency forced to withdraw draft guidance– Require Agency to submit report to Congress
addressing the key substantive, and controversial, provisions of the guidance
– Precludes Agency from issuing regulation or guidance before 1 year after submission of the report
User Fee Reauthorization: Regulatory Process Reforms
• De Novo Process Modification:– Eliminates NSE requirement– Allows de novo submitters to submit request for
classification and draft special controls– Establishes 120 day timeline for FDA to classify the
device– FDA can refuse de novo request where:
• A predicate exists• Device is not low or moderate risk• General controls or special controls cannot mitigate risks
User Fee Reauthorization: Regulatory Process Reforms
• Clarification of Least Burdensome standard• Reauthorization of Third-Party Review• Device Reclassification Procedures• Humanitarian Device Exemptions• Unique Device Identifier (UDI) -- for devices
that are implantable, life-saving and life-sustaining
• Inclusion of devices in FDA Sentinel program
FDA Regulatory Environment:Medical Device Tax
• Begins in 2013• $30 billion tax• Potential 43,000 jobs lost• Update on repeal efforts
Healthcare Reform Implementation
• Supreme Court ruling offers some finality• Next major steps:– Accountable Care Organizations– Essential benefits package– Insurance exchanges– Medicaid expansion– Independent payment advisory board
• Impact on VC & start-ups