Michelle Lott, RAQA Director, Xeridiem

1. Organizational Impacts of Regulatory
Change and Business Benefits
BIOMEDevice San Jose
December 4 2013
Michelle Lott
RA / QA Director

2. Candlestick Park Stadium –
Copyright 2013 Michelle Lott

3. Key Players
49ERS SIDELINE
CHARGERS
CHARGERS SIDELINE
Copyright 2013 Michelle Lott

4. Customer
Customer
Food and Drug Administration (FDA)
European Commission
Miscellaneous
Copyright 2013 Michelle Lott

5. PIP
ISO
Patient Harm
Guidance
Customer
Customer
NE
CP
Food and Drug Administration (FDA)
European Union (EU)
BOEING
Miscellaneous
Copyright 2013 Michelle Lott

6. FDA Prioritized medical device guidance documents that the
Agency intends to publish in FY 2013 ("A-list")
Final Guidance Topics
Refuse to Accept (RTA) Policy for 510(k) Submissions
Acceptance and Filing Review for Premarket Approval Applications
Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies,
Including Certain First in Human (FIH) Studies
In Vitro Companion Diagnostic Devices
Design Considerations for Pivotal Clinical Investigations for Medical Devices
De Novo Classification Process (Evaluation of Automatic Class III Designation)
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
CDRH Appeals Processes
Medical Device Classification Product Codes
The Pre-Submission Program and Meetings with FDA Staff
Mobile Medical Applications
eCopy
Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial
Agents
Draft Guidance Topics
Distinguishing and Reporting Medical Device Recalls from Product Enhancements
Types of Communication During the Review of Medical Device Submissions
FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
Copyright 2013 Michelle Lott

7. FDA Device guidance documents that the Agency intends to publish, as the
Agency’s guidance-development resources permit each in FY 2013 ("B-list")
Final Guidance Topics
Finalizing existing draft guidance documents.
Draft Guidance Topics
Benefit-Risk Determinations in Premarket Notifications (510(k)s)
Direct to Consumer (DTC) Genetic Testing: IVDs
Transfer of Ownership of a Premarket Notification (510(k)) - Questions
and Answers
Custom Devices
Copyright 2013 Michelle Lott

8. Not to mention …
• Medical device tax
• MDD recast
–
–
–
–
–
Qualified Person
Requires unannounced audits
Code of ethics for Notified Bodies
Change in definitions on device classification
Proposing change from “directive” to “regulations” so they
can be changed easier and faster.
Copyright 2013 Michelle Lott

9. Copyright 2013 Michelle Lott

10. Copyright 2013 Michelle Lott

11. ISO
Argentina
Guidance
Singapore
Israel
Miscellaneous
Copyright 2013 Michelle Lott
Customer
Customer
Food and Drug Administration (FDA)
European Union (EU)

12. Internal Key Players
Player
Role
CEO and Executive
Management
Owner
Coach
Recruiter
VP or Director of RAQA
Offensive Coordinator
Quality Engineer/
Regulatory Specialist
Quarter Back
Design and Manufacturing
Engineers
Copyright 2013 Michelle Lott
Linebacker
Fullback
Tackle
Guard

13. European Union (EU)
ISO
Guidance
Singapore
Israel
Customer
Customer
FDA
Argentina
PENALTY
Miscellaneous
• Non Approval
• Recall
• Reputation
Copyright 2013 Michelle Lott

14. European Union (EU)
Respect
DR
Optimize
DR
Argentina
Patient Harm
FDA
FUN
Guidance
Customer
Customer
ISO
Singapore
Israel
Personal Accountability
Miscellaneous
Copyright 2013 Michelle Lott
Integrity

15. So what can you do?
• Do be aware of changing expectations
– Write a gap analysis
– Write justifications for “not applicable” requirements – it’s
not obvious
– Ask the agency
– Create culture of empowerment
• Don’t fight it
– Your cheese has moved - trust your RA/QA group
– Be creative finding solutions – simple solutions do exist
– Look for existing tools that help you demonstrate how
requirements are fulfilled
Copyright 2013 Michelle Lott

16. Benefits of Keeping Up with Change
• Increased safety and efficacy
– Reduced cost of complaints and recalls
– Opportunity to increase market share when competitor has
recall
• Better meet patient/ market needs
– Usability studies ensure product meets market needs prior to
launch
– First release of product more quickly adopted by market
without numerous design iterations
• Products get to market faster
– Company makes money sooner
• Products stay on market longer
– Build company reputation for product quality and reliability
Copyright 2013 Michelle Lott

17. Your Vision. Designed. Delivered.
Copyright 2013 Michelle Lott