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FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health
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FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health


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Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process. The report covers the current scope of ...

Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process. The report covers the current scope of regulatory oversight, device classification and premarket requirements for digital health companies creating regulated products. Digital health entrepreneurs that have successfully navigated the process offer pointers and best practices to startups.

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Published in: Santé & Médecine, Affaires

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  • 1. A R O C K R E P O R T B Y A guide for digital health entrepreneurs FDA 101
  • 2. Rock Health funds and supports startups building the next generation of technologies transforming healthcare. Rock Health partners include Aberdare Ventures, Accel Partners, Genentech, Harvard Medical School, Kaiser Permanente, Kleiner Perkins Caufield & Byers, Mayo Clinic, Mohr Davidow Ventures, Montreux Equity Partners, NEA, Nike, Qualcomm, Quest Diagnostics, Silicon Valley Bank, UnitedHealth Group, and UCSF. For more information, visit About REPORT This is a commonly heard refrain from entrepreneurs who work in healthcare. We know regulation is for good reason—to protect the safety of consumers—and companies want the same. However, the FDA clearance/approval process can seem murky, challenging, and capital intensive. This guide is intended to introduce entrepreneurs to FDA regulation around medical devices and mobile medical apps. Please note that this report is partially based on draft FDA guidance and will be updated as new information is available. Future guides may cover the various submission processes in more depth and international markets. Special thanks to Chris Bergstrom, Geoff Clapp, Jeff Engler, Alex Frommeyer, Sridhar Iyengar, Mohit Kaushal, and Michael Righter for their time and insights, and to Jenna Green for contributing an early draft focused on medical devices. Produced by: this Deborah Pascoe @deborahpascoe Malay Gandhi @mgxtro When we learned that we would be regulated as a medical device, we were initially apprehensive about what this meant to us as an early stage company.” Jeff Engler Co-Founder, Podimetrics “ With help from: Holly May, Health Advances
  • 3. Presentation Ⓒ 2013 Rock Health The FDA Department of Health and Human Services Food and Drug Administration (FDA) Protecting the public health by assuring the safety, effectiveness, and security of: “• Human and veterinary drugs • Vaccines and other biological products • Medical devices FOCUS OF ROCK REPORT • Food supply • Cosmetics • Dietary supplements • Products that give off radiation • Tobacco MISSIONOVERVIEW Year formed FY12 budget Employees 1906 $3.8B 13,490 3 Source: FDA
  • 4. Presentation Ⓒ 2013 Rock Health Why is the FDA looking at digital health? 38K+ WIDESPREAD AVAILABILITY PUBLIC INTEREST healthcare and fitness apps 24K+ medical apps 19%of smartphone owners have downloaded an app to track or manage health 41% of consumers have a strong interest in remote monitoring devices to check condition and send information to doctor 4 Source: 148Apps, AppBrain, Pew Internet & American Life Project, Deloitte Center for Health Solutions
  • 5. Presentation Ⓒ 2013 Rock Health Scope of FDA regulatory oversight States that the FDA intends to apply its regulatory authority to mobile apps that are medical devices under current definition: 2012 2013 July 2011 draft guidance released March 2013 final guidance pending an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body Transforms one of these 1 Is used as an accessory to one of these2 into this AND EITHER OR DRAFT GUIDANCE: MOBILE MEDICAL APPS 5 Source: FDA
  • 6. Presentation Ⓒ 2013 Rock Health FDA regulation of “apps” No regulatory requirement Selective enforcement Mobile medical apps 60,000+ apps CURRENT GRAY AREA A mobile app that meets the definition of a medical device, but is not necessarily transforming a mobile platform into a medical device or acting as an accessory to a medical device, and hence is not a “mobile medical app” NOT A NEW FOCUS FOR THE FDA Note: not meant to be representative of % of apps in each category ~100 mobile medical apps reviewed since 1997 143 67 average days for 510(k) decision mobile medical apps only (1997-2012) 6 Source: FDA, average days for 510(k) decision is based on 98% of all submissions all submissions (2011)
  • 7. Presentation Ⓒ 2013 Rock Health Regulation—a burden, or strategy? Increased customer confidence New markets and channels Reduced business risk Discovery and correction of problems pre-market Consistent operating procedures Scalable quality assurance systems Added work and expense Delayed product launch Need for specialized expertise Clearance or approval uncertainty Market entry barrier Which lens? BENEFIT COST 7
  • 8. Presentation Ⓒ 2013 Rock Health “ Contact the FDA early to explain your idea, but developing a detailed regulatory strategy before you have developed a product is putting the cart before the horse; you should do both in parallel and iteratively. The FDA is very willing to give general feedback on whether you're on the right track and what gaps they see in your strategy. They are there to help guide you, but they are not there to act like free consultants, so you will need to plan to build out your own regulatory resources. SRIDHAR IYENGAR Co-Founder and Chief Technical Officer iBGStar Blood Glucose Monitoring System iBGStar Diabetes Manager Application FDA Class II Clearance Quantitative measurement of blood glucose levels; application with the capability of sending glucose readings through e-mail to an individual’s healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. 8
  • 9. Presentation Ⓒ 2013 Rock Health The regulatory path START I’m a medical device or mobile medical app CLASS III CLASS II CLASS I I’m not a medical device or mobile medical app You require FDA clearance or approval You could still be regulated by FCC, OCR or others 9
  • 10. Presentation Ⓒ 2013 Rock Health Is this a mobile medical app? • Electronic reference materials • Training materials • Log, record, track, evaluate, or make decisions related to general health and wellness • Healthcare administration, including billing, appointments, and insurance transactions • EHRs or PHRs • Generic aids not marketed for a medical indication • Control a medical device or display, store, analyze, or transmit patient-specific medical device data • Attachment, display screen, or sensor that transforms a mobile device into a medical device • Diagnosis, treatment recommendations, or clinical decision support by applying formulae or algorithms to patient-specific inputs YES NO KEY QUESTION: is your app’s intended use (alone or in concert with a device—regulated or otherwise) to diagnose, treat, mitigate, cure, or prevent a specific disease or condition? 10 Source: FDA, guidance interpretation by Rock Health
  • 11. Presentation Ⓒ 2013 Rock Health The three classes 11 Source: FDA CLASS I CLASS II CLASS III Does not support or sustain human life and has a significant history of safety and effectiveness low high Has a similar intended use and a safety and effectiveness profile of a device already on the market; risk requires special controls Supports or sustains life or high risk of injury; typically requires clinical studies demonstrating safety and effectiveness CONTROLS General General + Special General + Special + Ad hoc PREMARKET RISK TO PATIENT Most exempt from 510(k) clearance Most require 510(k) clearance Nearly all require premarket approval (PMA)
  • 12. Presentation Ⓒ 2013 Rock Health Hypothetical example CLASS I CLASS II CLASS III low high Bandage Covering a wound Reporting on a wound Treating a wound + + Mobile phoneSmart Bandage Mobile phoneSmart Bandage Wound temperature Wound temperature, humidity, size Algorithm-derived dose for medication 12 Note: Only the FDA can designate a device to be a certain class; above examples are not real RISK TO PATIENT
  • 13. Presentation Ⓒ 2013 Rock Health “ Ask yourself: what’s your product and what’s your value proposition? Then, marry those with the appropriate regulatory path and business model. For example, if your model is based on reimbursement, then you’ll likely need published clinical outcomes and FDA clearance. CHRIS BERGSTROM Chief Strategy and Commercial Officer DiabetesManager System & DiabetesManager-Rx System FDA Class II Clearance Provides secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self- management. 13
  • 14. Presentation Ⓒ 2013 Rock Health Novelty versus predicate device SmartTrack System FDA Class II Clearance (October 2009) Intended for single-patient use as an electronic data capture accessory for recording and monitoring actuations of prescribed MDI usage. Unlike patents, demonstration of novelty scores no points with the FDA for Class II—the focus should be on showing equivalence to a predicate device in order to gain clearance Asthmapolis System FDA Class II Clearance (July 2012, found to be substantially equivalent to the SmartTrack system) Intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MIDI usage. Technological characteristics of the Asthmapolis System and the SmartTrack System are largely equivalent. 14 Source: SmartTrack and Asthmapolis FDA filings
  • 15. Presentation Ⓒ 2013 Rock Health Too innovative for a predicate By default, any medical device that presents risk and is without a predicate is Class III, but through a de novo petition can be re-classified as Class I or II Proteus Personal Monitor including Ingestion Event Marker FDA Class II de novo (July 2012) ? Not substantially equivalent (NSE) to any cleared or approved medical device Intended for ambulatory recording of heart rate, activity, body angle relative to gravity, and time-stamped, patient- logged events, including events signaled by swallowing the Ingestion Event Marker (IEM) accessory. 15 Source: Proteus Digital Health filings
  • 16. Presentation Ⓒ 2013 Rock Health The 510(k) process • Define your intended use: this will control how your device can be used and marketed, ultimately defining your customer value proposition • Determine the class of device • Find predicate device(s) • Open a dialogue with FDA • Prepare documentation: intended use statements, software and mechanical specifications, validation • Perform risk assessments and put control measures in place • Develop quality systems and standard operating procedures • Prepare the 510(k) submission • Submit a small business qualification certification to pay a reduced user fee • Pay the user fee ($2,480) • Submit the 510(k) electronically and via mail FDA acknowledges receipt and assigns a reference number A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as (i.e., substantially equivalent to) a legally marketed device that is not subject to premarket approval. Within 15 days Average of 67 days for mobile medical apps PRE POST SUBMISSION 16 Source: FDA FDA mails and faxes a decision regarding the application Questions and responses exchanged by FDA and applicant as needed
  • 17. Presentation Ⓒ 2013 Rock Health “ What the FDA is asking for is essentially basic software controls. Good software engineers do these things naturally—code reviews, unit testing, system-level testing, change control, etc. These approaches are routinely used by experienced developers who value rigor and process in their software deployment methods. MICHAEL RIGHTER Director, Regulatory Affairs AliveCor Heart Monitor for iPhone FDA Class II Clearance Records, displays, stores and transfers single-channel electrocardiogram (ECG) rhythms for licensed medical professionals or patients. 17
  • 18. Presentation Ⓒ 2013 Rock Health The PMA process • Define your intended use: this will control how your device can be used and marketed, ultimately defining your customer value proposition • Open a dialogue with FDA • Determine whether to use a traditional, modular (application submitted in components as they are ready) or streamlined (pilot program for familiar products) PMA approach • Prepare documentation: intended use statements, software and mechanical specifications, non-clinical laboratory investigations, clinical investigations • Perform risk assessments and put control measures in place • Develop quality systems and standard operating procedures • Prepare the PMA application • If this is the first PMA submission and <$30M revenue, fees are waived, otherwise, small businesses pay $62,000 • Pay the user fee if required • Submit the PMA electronically and via mail FDA mails and faxes a decision regarding the application A premarket approval (PMA) application is a scientific and clinical submission made to the FDA to demonstrate that the device to be marketed is safe and effective; to date, no mobile medical apps have required a PMA. Within 45 days Most likely >180 days to complete review PRE POST SUBMISSION 18 Source: FDA FDA files the PMA if it meets basic adequacy in technical elements Questions and responses exchanged by FDA and applicant as needed
  • 19. Presentation Ⓒ 2013 Rock Health Not so fast: post-market REQUIREMENTS AND CONSIDERATIONS Marketing Distribution Tracking DON’T GET TOO CREATIVE FINDING CUSTOMERS SURVEILLANCE FOR LIFE • No marketing or labeling outside of the approved intended use (for whom and for what) • Free to describe the device as “FDA Cleared” or “FDA Approved” as appropriate • For some device categories, reimbursement codes may already exist • For others, the value proposition will need to be taken to payers and prescribers to secure reimbursement and distribution • FDA can inspect quality systems agreed to at clearance/approval any time • Consistent tracking procedures are needed around design, manufacturing, sourcing, change control, QA testing, adverse event reporting, and customer complaints 19
  • 20. Presentation Ⓒ 2013 Rock Health “ Remember, the FDA may not be the only organization you need to work with before marketing your digital health device. We were surprised at the number of authorizations we needed, from the FDA and FCC to Apple MFi and Bluetooth. ALEX FROMMEYER CEO and Co-Founder Beam Brush / Beam App FDA Class I Clearance A toothbrush to remove plaque and debris from its user's teeth and aid in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device. 20
  • 21. Presentation Ⓒ 2013 Rock Health Pro-tips STAFFING BRING IT IN HOUSE COLLABORATION EARLY AND OFTEN DOCUMENTATION PLAN UPFRONT • Don’t rely on consultants—bring an experienced regulatory and quality person in-house that has worked with FDA before • An in-house person who will have to live with the procedures they design is more likely to think long-term and develop methods that are workable and appropriate for the company • Maintain a positive relationship with FDA—there are real people on the other side doing their best to protect consumers • Anticipate FDA's follow up questions, and be proactive about doing additional studies in parallel while awaiting a response • Figure out what FDA really wants if they ask for burdensome things—dialogue can usually uncover underlying needs • Invest in good tracking tools upfront: project management, quality/bugs, traceability and document repositories; some of the enterprise tools are FDA friendly, but can be cost-prohibitive for startups—ensure that they meet your needs before purchasing • When you generate policies and procedures for building and testing product, strike a balance; don't be so conservative that you cannot adjust to market needs and don't be so flexible that FDA has concerns 21
  • 22. Presentation Ⓒ 2013 Rock Health What’s next? 22 July 2011 draft guidance released 20142012 2013 YOU TELL US: What should a future guide cover? E-mail us at March 2013 Congressional hearings held October 2013 Final guidance issued (likely by this date) Will clarify selective enforcement but unlikely to change overall oversight approach Source: FDA
  • 23. For a huge percentage of digital health companies, following FDA regulations will actually make them a better company, with a higher quality process, and open the door to the entire healthcare market, including enabling them to bid on contracts with some of the largest government institutions. Entrepreneurs should embrace, not fear, the FDA. “ GEOFF CLAPP Co-Founder and Former CTO Health Hero Network Mentor, Rock Health
  • 24. Presentation Ⓒ 2013 Rock Health Notes 3 FDA statistics and facts 4 iOS apps Android apps Pew Internet & American Life Project: Tracking for Health Deloitte 2012 Survey of Health Consumers 5 Further reading: FDA Draft Guidance for Mobile Medical Applications 6 Mobile Medical App review length and total reviews (Hearing video) 2011 and 2010 average review length for all 510(k)s 10 Based on FDA Draft Guidance for Mobile Medical Applications 11 Further reading: Device classification Further reading: General and special controls 14 SmartTrack FDA filing Asthmapolis FDA filing 15 Proteus Digital Health FDA filing 16 Further reading: 510(k) (premarket notification) 18 Further reading: Premarket approval (PMA) 19 Further reading: Postmarket requirements 22 Expected issuance of final guidance and scope (Hearing video)
  • 25. Presentation Ⓒ 2013 Rock Health Our portfolio 2011 2012 2013 V1: 15 companies V2: 13 companies V3: 7 companies (Boston) June-November 2011 January-May 2012 June-August 2012 V4: 14 companies October 2012-February 2013
  • 26. @rock_health GET IN TOUCH