1. digital Health @ FDA Bakul Patel
June 6, 2019

2. Image Credit: Time Magazine
Effects of Moore’s Law
Grossman, Lev “The Singularity – 2045: The Year Man Becomes Immortal.” Time Magazine. Published Feb. 2011: 4 Pages. Time.com. Accessed Mar. 2019
Image Credit: Time Magazine

3. FDA Recognizes Increasing Digitization Across the Healthcare Continuum
Moving healthcare from the clinic to the patient.
Understanding patient’s behavior and physiology “in the wild.”
Focusing on prevention for early/smaller interventions.
Leveraging computing power, sensors, connectivity, and software.

4. Digital Health Team Vision
____
Digital Health Team Vision
Prepare the FDA for the Digital Health future by promoting innovation and ensuring all Americans have timely access to high-quality, safe and effective digital health products.

5. Digital Health Technology
Digital health technology is the convergence of computing power, connectivity, sensors, and software used in healthcare.
Used as a medical product;
Incorporated into a medical product (include a pharmacologic product);
Used to develop a medical product;
Used to study a medical product;
Used as a companion or adjunct to a medical product, including diagnostics and therapeutics.

6. Embracing Digital Health Innovation
Digital tools can provide consumers with valuable health information.
What qualifies as a digital health product?
What digital health technologies need regulation?
Left side is benefits of digital health
Right side are questions that FDA should consider
Consumers who are better informed about health make better decisions.

7. Fostering Responsible Digital Health Innovation
Goals for a Tailored Regulatory Framework
Fostering Responsible Digital Health Innovation
Enhance patients access to high quality digital medical products
Enable manufacturers to rapidly improve software products with minor changes
Maintain a reasonable assurance of safety and effectiveness
Minimally burdensome

8. FDA approach to regulation of digital health products

9. A Risk-Based Approach…
Increasing Risk
Classification determines extent of regulatory control (Risk Based)
Class III
General controls
Premarket approval (PMA)
Class II
General controls
Special controls
Class I
General Controls
General Controls
Electronic Establishment Registration
Electronic Device Listing
Quality Systems
Labeling
Medical Device Reporting (MDR)
Premarket Notification [510(k)] (unless exempt)
Special Controls (addressing Risk)
Guidelines (e.g., Glove Manual)
Mandatory Performance Standard
Recommendations or Other Actions
Special Labeling

10. …Aimed At Smart Regulation
Risk Based
Narrowly Tailored
Functionality Focused
Platform Independent

11. Focus on Higher-Risk Functionalities
Lower risk functionalities
FDA does not intend to enforce applicable regulatory requirements
Higher risk functionalities
FDA provides appropriate oversight to ensure patient safety while support timely access to innovative products

12. Mobile Medical Apps (MMA)
A “Mobile Medical App” is a mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and either is intended:
to be used as an accessory to a regulated medical device; or
to transform a mobile platform into a regulated medical device
MMA Guidance Document
Focus of oversight
MMA
Lower risk
mobile apps that meet the definition of a medical device
Mobile apps that do not meet
the definition of a medical device

13. Tools available from FDA

14.    Global Convergence 
2013 Foundational vocabulary
2014 – Risk framework based on impact to patients
2015 – QMS control Translating Software development practices to regulatory QMS
SaMD –Clinical Evaluation Generating evidence for clinically meaningful SaMD    

15. 21st Century Cures Act
Codifies current policies and excludes certain software products from medical device definition:
Medical device data systems
EHR certified by ONC
General wellness products
Administrative products
Excludes certain types of clinical decision support products from the definition of a medical device. Excluded products must meet all of the following criteria:
Does not acquire or analyze physiological signals;
Is intended to display information about a patient;
Provides recommendations to physicians; and
Allows health care professionals to independently review the basis for such recommendations.
For products with multiple functions, allows FDA to regulate only those functions that meet the definition of a medical device

16. FDA Pre-Cert Program
An organization-based streamlined regulatory approach
for
Software as a Medical Device (SaMD)
that relies on a demonstrated
Culture of Quality and Organizational Excellence

17. Five Excellence Principles Proposed
Patient
Safety
Demonstration of a commitment to providing a safe patient experience, and to emphasizing patient safety as a critical factor in all decision-making processes.
Product Quality
Demonstration of a commitment to the development, testing, and maintenance necessary to deliver SaMD products at the highest level of quality.
Clinical Responsibility
Demonstration of a commitment to responsibly conduct clinical evaluation and to ensure that patient-centric issues including labeling and human factors are appropriately addressed.
Cybersecurity Responsibility
Demonstration of a commitment to protect cybersecurity, and to proactively address cybersecurity issues through active engagement with stakeholders and peers.
Proactive Culture
Demonstration of a commitment to a proactive approach to surveillance, assessment of user needs, and continuous learning.

18. Our Goals For a New Model
How can a pre-certification program address the evolving needs of SaMD products?
Enable a tailored, pragmatic, and least burdensome regulatory oversight that
Assesses organizations to establish trust that they have a culture of quality and organizational excellence such that they can develop high quality SaMD products;
Leverages transparency of organizational excellence and product performance across the entire lifecycle of SaMD;
Uses a tailored streamlined premarket review;
Leverages unique postmarket opportunities available in software to verify the continued safety, effectiveness, and performance of SaMD in the real world.

19. Digital Health Center of Excellence
“ We’re building our Digital Health Center of Excellence to develop more efficient ways to ensure the safety and effectiveness of technologies like smart watches with medical apps. Our Software Precertification Pilot Program is allowing us to test a new approach for product review. ”
Dr. Scott Gottlieb, FDA Commissioner
April 2, 2019

20. Concept: A Reimagined Approach Using FDA Pre-Cert
Commercial Distribution & Real-World Use
e.g. lower-risk software, certain modifications
Real World Data Collection
Based on SaMD Risk + Pre-Cert level
Streamlined Premarket Review
FDA Pre-Cert
level
Clinical Trials
Regulatory Science
Real-World Evidence
Outcomes research
Patient Preference DH
feedback
FDA Pre-Cert effectiveness feedback
Assessment effectiveness feedback

21. Reimagining the Regulatory Approach
While maintaining reasonable assurance of safety and effectiveness
Today’s Device World
(Hardware-based)
Digital Health Device World (Software-Based)
Leverages real world performance data
Pre-Market Organization-Level Data
Pre-Market Product-Level Data
Post-Market Data
Go-To-Market
Shortens the timeline for premarket product review
On the left side is the current regulatory pathway FDA uses when reviewing products. This was designed for hardware-based products and limited organizational data and postmarket data is available to us. In the reimagined approach for software, FDA takes advantage of the wealth of real world data, and decreases the pre-market product review time period while still ensuring safety.
This approach enables the evaluation and monitoring of a software product from its premarket development to post-market performance, along with continued demonstration of the organization’s excellence.
Adds appraisal of company’s culture of excellence

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