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
Center for Devices and
Radiological Health
Center for Drug
Evaluation and Research
Center for Veterinary
Medicine
Center for Biologic
Evaluation and Research
Center for Food Safety
and Applied Nutrition
Office of Regulatory
Affairs
FDA
Center for Tobacco
Protect and Promote Public Health
Agenda
1. Where Are We Now?a. Policy
b. Submissions
2. Opportunities
3. Misconceptions
4. Future
Where Are We Now?
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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
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
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
Where Are We Now?
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
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.
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.
Speed Access to Management Tools
Community Input
• Guidance Comments!
• Patient Town Hall on Unmet Needs
• Regulatory Considerations for Software used in Diabetes Management
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 approved for patients 2 years old and up
• Dexcom Share System
• New Dexcom Algorithm: Software 505 update
Agenda
1. Where Are We Now?a. Policy
b. Submissions
2. Opportunities
3. Misconceptions
4. Future
• 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
Opportunities: Interoperability
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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 outcomes17
Opportunities: Interoperability
• Remote Monitoring
• Device Consolidation
• AP Components
Artificial Pancreas
19
• 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)
• Opportunity: more choices/access
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
20
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.
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 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
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
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.
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
• Participate in Public Meetings (in Person or Webcast)
• Become informed on the facts (from all perspectives)
FDA
Funding Groups
Industry
Patients and Advocates
Healthcare Providers
Research
Questions?
Thank you!