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

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!