Mobile, Connected, Digital Health Bakul Patel, MBA

Facilitating medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Enable “patient centered” public health as digitization touches every aspect of health care

Foster trust in innovative technologies as an enabler of a new healthcare paradigm

Partner with stakeholders to be "digital-future ready”

CDRH Objectives

Transforming the regulatory environment is becoming more challenging due to increasing complexities in the medical device innovation

Software is becoming more ubiquitous within medical devices; this results in an increased burden on regulatory agencies to conduct reviews in a timely fashion.

Medical Device Software Regulation What strategies can be employed to streamline review of medical device software without sacrificing regulatory oversight?

Changing Technology Landscape The rate of technology change presents significant challenges to the regulator. Innovation will continue to advance in the areas of microprocessors, material science, and manufacturing.

What approaches can be developed to strengthen the depth of expertise of the regulator when it comes to rapid changes in technology?

Real-World Evidence

Real-world data can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients

How does real-world evidence collection fit into the FDA’s strategic priority of creating a national evaluation system for medical devices?

Exploring the Issue

Risk based

Functionality focused

Platform independent

Promote innovation

Narrowly tailored

Promote patient

engagement

Protect patient safety

Smart Regulation

Don’t intend to enforce regulatory requirements

Appropriately oversee to assure patient safety while considering advances in technology and product life-cycle •  Engaging stakeholders •  Implementing policies •  Raising staff expertise and

knowledge

Lower Risk Functionality

Higher Risk Functionality

Focusing on Higher Risk Functionality

6

Foundational Policies

RF Wireless -guidance

Mobile medical app (MMA)

FDASIA Health IT report

Premarket Cybersecurity

MDDS/image storage and communication

General wellness

Accessories Interoperability

Post-market cybersecurity

MMA update

7

Approach to Mobile Apps

No regulatory requirements

•  Patient self-management apps •  Tools to organize and track their health

information (not for treating or adjusting medications)

•  Tools to access to health information document and communicate with health care providers

•  Tools that automate simple health care providers tasks

Enforcement Discretion

Mobile apps not considered

“medical devices”

MMA

Lower risk mobile apps that meet “device”

Definition but not considered “MMA”

Mobile apps that meet “device” definition that are either intended •  To be used as an accessory to

already regulated medical device, or

•  To transform a mobile platform into a regulated medical device.

focus of oversight

8

Types of Medical Device Software

So$wareusedinthemanufacturingprocess

ofadevice

So$wareasadevice

So$wareinadevice

in as

u

9

On a Path Towards Global Convergence

2013 Foundational vocabulary

2014 – Risk framework based on impact to patients

2015 – QMS control èTranslating Software development practices to regulatory QMS

SaMD –Application of Clinical Evaluation

þ

þ

þ

White Oak, February 2016

www.fda.gov 10

Envisioning DH Paradigm

An Agile and learning regulatory paradigm that is:

An opportunity to work together to build this vision and prepare for a digital health future

Aligned with Product development timelines

Aligned with industry practices and real world

experience

Aligned with global regulators

DH TPLC

Clinical Trials

Regulatory Science

NEST

Progressive Approval, Safety and

Performance

Premarket-Postmarket

Balance AssuranceProgram

DH

DH Bakul

FDA Initiatives

FDAPre✔ RegulatoryDevelopmentKit

NEST

Digital Health and Mobile Apps email: DigitalHealth@fda.hhs.gov

Digital Health Contact

CDRH website: Digital health page http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

•  What talent (skills, expertise, experience) should the FDA crowdsource?

•  How should we differentiate digital health medical devices from traditional medical devices?

•  What would you like to see part of a potential FDA pre-check program?

•  What format / key components would be most useful for a regulatory development kit?

•  How else could we achieve the same objectives?

We Need Your Input

Mariya Filipova mfilipova@deloitte.com

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