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Modernizing FDA for the Age of Medical Product Connectivity Bradley Merrill Thompson
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© 2014 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. EBGLAW.COM
Unique features of connected technologies
Unique features of connected business models
Topics for Discussion
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Ambiguity and the entrepreneur
FDA Modernization ideas
© 2014 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. EBGLAW.COM
Contemplate the network No predefined clinical intended use
Interoperability
Standalone software that plays clinically significant roles
Remote site of service Home use and mobile type considerations
Human factors
Telemedicine type issues The impersonal touch
New FDA Regulatory System Requirements: Technology
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Collaboration among IT technical experts, clinicians, medical device developers and scientists of many sorts.
Virtual development processes
Even shorter product lifecycles
Modularization of software
Easier entry for those not experienced in health
New FDA Regulatory System Requirements: Business Model
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Ambiguity can be good or bad
Good Bad
Liberals arts majors
Regulatory standard
Engineering majors
Scope of FDA regulation
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A holistic regulatory system for a connected care delivery system
Needed: A Systems Approach
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Connected health technologies, including standalone software
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Regulatory Reform Blueprint
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Disease v. wellness
Accessory rule
Software modules
Clinical Decision Support
We do need to anticipate new technologies and
we do need flexibility to provide for learning more about risk.
Resolving Ambiguity
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Specific Needed Improvements
Innovation Factor Needed Regulatory Change
1. Cost and timelines for developing products
Clarity and predictability in the pathway
Classification: I, II or III
2. The accessibility of regulatory requirements to small business
More outreach
User-friendly web-based information
Face-to-face educational programs
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New Approach
Innovation Factor Needed Regulatory Change
3. Components for unspecified systems Tool intended uses
Accessory classifications
4. Release of beta software programs Clarification on how investigational device rules apply to regulated software
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New Approach
Innovation Factor Needed Regulatory Change
5. Frequent incremental improvements to software
Clear triggers for premarket requirements
6. Key role of standalone software Guidance on
Premarket data requirements
Quality system regulation
Postmarket reporting obligations
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New Rules Needed for Scientific Exchange
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Allow manufacturers to collaborate with customers actively
Build virtual collaboration tools and in person events for scientific exchange
Use their own people, including commercial, to build the community through proactive outreach
Allow their own scientific people to engage in the scientific discussion by sharing data, including journal articles
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Good guidance practice 2.0
It’s time
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How would FDA answer questions if it were located in Silicon Valley?
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Opportunities for Improving Guidance
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Technologies such as Chat room capability and
Electronic knowledge databases
Best practices for handling handle external communications
Shift the laboring oar to industry
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Watch the innovation blossom
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Bradley Merrill Thompson (202) 861.1817 [email protected]
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