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Annual FDA Update 
DiabetesMine Innovation Summit 
November 21, 2014 
Stayce Beck, Ph.D., M.P.H. 
Office of In Vitro Diagn...
Center for Devices and 
Radiological Health 
Center for Drug 
Evaluation and Research 
Center for Biologic 
Evaluation and...
Agenda 
1. Where Are We Now? 
a. Policy 
b. Submissions 
2. Opportunities 
3. Misconceptions 
4. Future
Where Are We Now? 
http://smallbiztrends.com/2012/04/buil http://www.acclaimimages.com/_gallery/_pages/0515-1003-2513-2218...
Glucose Meter Guidances 
• Two documents describing different intended use 
populations 
– SMBG: OTC, intended for lay-use...
Overview of Comments from Individuals, Academics, 
Health Professionals/Associations (544 comments): 
Comments Regarding B...
Overview of Comments from Device 
Industry/Associations (29 comments): 
Comments Regarding Both Guidances: 
• Request the ...
Where Are We Now?
Mobile Medical Apps Guidance 
• Mobile App 
– a software application that can run on a mobile platform (i.e., a handheld 
...
MDDS Draft Guidance 
• MDDS - Medical Device Data System 
• MDDS is: hardware or software products that transfer, store, c...
Speed Access to Management Tools 
New product code – PHV – defines new regulation to 
facilitate mHealth 
• Would have bee...
Community Input 
• Guidance Comments! 
• Patient Town Hall on Unmet Needs 
• Regulatory Considerations for 
Software used ...
Agenda 
1. Where Are We Now? 
a. Policy 
b. Submissions 
2. Opportunities 
3. Misconceptions 
4. Future
Where Are We Now? 
• Nova Glucose Stat Strip hospital meter for use in 
critically ill patients cleared 
• Dexcom G4 appro...
Agenda 
1. Where Are We Now? 
a. Policy 
b. Submissions 
2. Opportunities 
3. Misconceptions 
4. Future
Opportunities: Interoperability 
• Diabetes-related interoperability is high priority. 
• Ability to link CGM, glucose met...
Benefits of Interoperability 
• Integrate data from multiple devices, easier data 
interpretation, standard format and met...
Opportunities: Interoperability 
• Remote Monitoring 
• Device Consolidation 
• AP Components
Artificial Pancreas 
• Challenge: how to bring disparate parts together 
to form one system 
• Traditional pathway = one c...
Alternate Pathways Considerations 
• Technical Solutions: 
• Device specifications to ensure each performs as required 
• ...
Agenda 
1. Where Are We Now? 
a. Policy 
b. Submissions 
2. Opportunities 
3. Misconceptions 
4. Future
AP Common Misconceptions 
• An AP does not have to develop/approve in a measured 
progression 
No reason not to try to dev...
AP Common Misconceptions 
• HbA1c is not the only endpoint FDA will accept for AP 
studies 
Endpoint should be what makes ...
Common Misconceptions 
• FDA won’t allow updates for software compatibility 
Sponsors do not have to come in for these typ...
Agenda 
1. Where Are We Now? 
a. Policy 
b. Submissions 
2. Opportunities 
3. Misconceptions 
4. Future
What Can You Do? 
• Report adverse events (to the manufacturer and the FDA) 
• Comment to the Docket for draft guidances 
...
FDA 
Funding Groups 
Industry 
Healthcare Providers 
Patients and Advocates 
Research
Questions? 
Thank you!
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Stayce Beck: "Annual Update on FDA Innovation Pathways" at the 2014 DiabetesMine Innovation Summit at Stanford School of Medicine

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Stayce Beck, FDA branch chief for the Diabetes Diagnostic Devices Branch, presented an annual update on FDA Innovation Pathways at the 2014 DiabetesMine Innovation Summit at Stanford School of Medicine.

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Stayce Beck: "Annual Update on FDA Innovation Pathways" at the 2014 DiabetesMine Innovation Summit at Stanford School of Medicine

  1. 1. Annual FDA Update DiabetesMine Innovation Summit November 21, 2014 Stayce Beck, Ph.D., M.P.H. Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health/FDA Stayce.beck@fda.hhs.gov
  2. 2. Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Biologic Evaluation and Research Center for Veterinary Medicine Center for Food Safety and Applied Nutrition Office of Regulatory Affairs FDA Center for Tobacco Protect and Promote Public Health
  3. 3. Agenda 1. Where Are We Now? a. Policy b. Submissions 2. Opportunities 3. Misconceptions 4. Future
  4. 4. Where Are We Now? http://smallbiztrends.com/2012/04/buil http://www.acclaimimages.com/_gallery/_pages/0515-1003-2513-2218.html d-your-listening-muscle.html
  5. 5. Glucose Meter Guidances • Two documents describing different intended use populations – SMBG: OTC, intended for lay-user population – BGMS: Point of Care (used in settings such as hospitals, ER, ambulances, physician’s office, etc.) • Performance Studies/Criteria tailored to meet different intended use population needs • Flex studies (short sample, temperature/humidity) • Lot release criteria- may prevent release of less accurate strips • Cleaning and Disinfection
  6. 6. Overview of Comments from Individuals, Academics, Health Professionals/Associations (544 comments): Comments Regarding Both Guidances: • Support tighter accuracy requirement • Support emphasis on test strip lot release criteria • Request a more robust MDR policy • Request post market surveillance testing to ensure that meters on the market perform within their cleared % accuracy • Comments on the naming of meters Comments Regarding the POC Guidance: • Request that meters continue to be CLIA waived Comments Regarding the OTC Guidance: • Support front of box accuracy requirement • Meters that don’t meet accuracy requirements shouldn’t be considered durable medical equipment
  7. 7. Overview of Comments from Device Industry/Associations (29 comments): Comments Regarding Both Guidances: • Request the removal of Test Strip Lot Criteria Section • Request modifications to Hematocrit and Interference study designs • Request clarifications on stability and flex testing Comments Regarding the POC Guidance: • Request alternate accuracy criteria Comments Regarding the OTC Guidance: • Request alternate accuracy criteria • Requests related to the labeling
  8. 8. Where Are We Now?
  9. 9. Mobile Medical Apps Guidance • Mobile App – a software application that can run on a mobile platform (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity) – a web-based software application that is tailored to a mobile platform but is executed on a server • Mobile Medical App – A mobile app that meets the definition of a medical device and is intended • to be used as an accessory to a regulated medical device; or • to transform a mobile platform into a regulated medical device • FDA: – applies its regulatory oversight to mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. – Exercise enforcement discretion for mobile apps that help patients self-manage their disease or conditions without providing specific treatment or treatment suggestions, automate simple tasks for HCP, provide simple tools to organize and track patient health information
  10. 10. MDDS Draft Guidance • MDDS - Medical Device Data System • MDDS is: hardware or software products that transfer, store, convert formats, and display medical device data • MDDS does not: modify the data, and it does not control the functions or parameters of any connected medical device. • MDDS are not intended to be used in connection with active patient monitoring. • February, 2011 – MDDS regulated as Class I (low risk). • June 2014 - MDDS Draft Guidance issued to inform manufacturers, distributors, and other entities of the Agency intention to exercise enforcement discretion for MDDSs.
  11. 11. Speed Access to Management Tools New product code – PHV – defines new regulation to facilitate mHealth • Would have been Class III, now Class I, exempt • Don’t have to come in with premarket submission for devices that analyze and correlate retrospective data from a CGM device • Should allow for updates to software to get to users more quickly, since won’t have to wait for FDA approval.
  12. 12. Community Input • Guidance Comments! • Patient Town Hall on Unmet Needs • Regulatory Considerations for Software used in Diabetes Management
  13. 13. Agenda 1. Where Are We Now? a. Policy b. Submissions 2. Opportunities 3. Misconceptions 4. Future
  14. 14. Where Are We Now? • Nova Glucose Stat Strip hospital meter for use in critically ill patients cleared • Dexcom G4 approved for patients 2 years old and up • Dexcom Share System • New Dexcom Algorithm: Software 505 update
  15. 15. Agenda 1. Where Are We Now? a. Policy b. Submissions 2. Opportunities 3. Misconceptions 4. Future
  16. 16. Opportunities: Interoperability • Diabetes-related interoperability is high priority. • Ability to link CGM, glucose meter and insulin pump data. • Important because: – Enables companies to work together – Allows patients access to information from many devices • Lack of interoperability limits innovation and slows the development of new diabetes management tools https://agaroli.wordpress.com/category/negative-influences/
  17. 17. Benefits of Interoperability • Integrate data from multiple devices, easier data interpretation, standard format and metrics • Improved patient interaction with healthcare professionals • Consolidation of devices (meters, pumps, CGMs, cell phones, etc.) • Consolidation of software/applications • Remote upload/data access capabilities (cloud computing) • Easier/faster download capabilities • Better diabetes care, better outcomes 17
  18. 18. Opportunities: Interoperability • Remote Monitoring • Device Consolidation • AP Components
  19. 19. Artificial Pancreas • Challenge: how to bring disparate parts together to form one system • Traditional pathway = one company sells whole AP device (sensor, pump, algorithm) • Alternate pathway = different companies sell the components of an AP (e.g., algorithm on an app that communicates with pump and sensor) 19 • Opportunity: more choices/access
  20. 20. Alternate Pathways Considerations • Technical Solutions: • Device specifications to ensure each performs as required • Interoperability controls or standards to ensure devices communicate and work together reliably • Responsibility: • Complaint investigation and resolution • Adverse event investigation and reporting • Impact of device modifications/generations to the system At the end of the day the system as a whole has to work reliably and someone must take responsibility to ensure that it does so. 20
  21. 21. Agenda 1. Where Are We Now? a. Policy b. Submissions 2. Opportunities 3. Misconceptions 4. Future
  22. 22. AP Common Misconceptions • An AP does not have to develop/approve in a measured progression No reason not to try to develop the fully closed loop device if the technology is ready! • Remote monitoring can be a good safety mitigation in studies, but is not always required There are many ways to mitigate the risk in clinical studies • Enacting safety mitigations for studies does not mean that these mitigations have to be part of the final system Study mitigations are for the safety of study participants and are not part of the device itself
  23. 23. AP Common Misconceptions • HbA1c is not the only endpoint FDA will accept for AP studies Endpoint should be what makes sense for the claims being tested • Artificial Pancreas devices do not have to be perfect with zero risk to be beneficial Approval Decision made in the context of benefits of the device compared with the significant risks people with diabetes face every day due to their disease
  24. 24. Common Misconceptions • FDA won’t allow updates for software compatibility Sponsors do not have to come in for these types of updates, just report it at the end of the year in the annual report when part of a PMA device. • FDA won’t let us do that because of HIPAA HIPAA is the health insurance portability and accountability act and protects the privacy of individual identifiable information. This is enforced by the Office of Civil Rights in HHS. FDA does not enforce HIPAA, though we do recommend that device makers be compliant with HIPAA.
  25. 25. Agenda 1. Where Are We Now? a. Policy b. Submissions 2. Opportunities 3. Misconceptions 4. Future
  26. 26. What Can You Do? • Report adverse events (to the manufacturer and the FDA) • Comment to the Docket for draft guidances • Participate in Public Meetings (in Person or Webcast) • Become informed on the facts (from all perspectives)
  27. 27. FDA Funding Groups Industry Healthcare Providers Patients and Advocates Research
  28. 28. Questions? Thank you!

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