Brendan O’Leary

Brendan worked at the FDA for 14 years in a variety of roles, most recently as the founding Deputy Director of the Digital Health Center of Excellence and as its Acting Director throughout 2022. Brendan contributed to hundreds of precedent-setting decisions and co-authored dozens of policy documents that continue to provide the foundation for the FDA's digital health efforts. He frequently represented the FDA on digital health and other topics through presentations at conferences and professional society meetings, press interviews, and interactions with Congress.

At the FDA, Brendan championed and led successful efforts to increase regulatory flexibility for lower-risk technologies while advancing policies and regulatory approaches that promoted the use of safety-enhancing software engineering techniques in the medical technology industry, especially practices related to continuous integration and continuous delivery (CI/CD). He drove policy efforts to enable rapid modification and continuous learning techniques for artificial intelligence and machine learning technologies, and he worked with Congress and other stakeholders to extend these efforts to all medical devices with legislation passed and signed into law in December 2022.

Brendan also made significant contributions to the federal government's response to SARS-CoV-2.

He continues to promote regulatory approaches that improve medical device interoperability, improve user access to medical device data, provide users with more control over home-use medical devices, facilitate open-source development of medical device software, and appropriately increase over-the-counter access to medical technologies.

Early in his career, Brendan designed and developed tools that were used by NASA astronauts to repair the Hubble Space Telescope. He has a B.S. in Mechanical Engineering from the University of Maryland, College Park.

Brendan lives in Maryland with his wife, Jessica, and their dog, Bear.

Experience

U.S. Food and Drug Administration (FDA)

Silver Spring, MD
Various Positions (see below)
Apr 2009 – Apr 2023

Acting Director, Digital Health Center of Excellence

Feb 2022 – Jan 2023

• Led policy and regulation efforts across the Center for Devices and Radiological Health (CDRH) and the FDA to foster responsible digital health innovation, ensuring that patients in the US have timely access to safe and effective digital health devices and technologies. This included the development of Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, which was subsequently issued for public comment in March 2023, and Content of Premarket Submissions for Device Software Functions, which was subsequently finalized in June 2023.

• Built broad and effective coalitions around innovative regulatory frameworks and approaches to digital health devices and technologies, including in partnership with other CDRH and FDA components, through collaborative communities, through public private partnerships, through collaborations with international regulators, through engagements with other federal agencies, through FDA’s policy and legislative efforts, and by engaging a range of stakeholders through the trade-press and other outreach efforts.

• Dec 2022: As a result in part of technical assistance provided by the DHCoE, Congress passed and the President signed into law legislation on the use of Predetermined Change Control Plans (PCCPs) for medical technologies. This legislation builds on concepts proposed in FDA pilot programs, action plans, and discussion papers. It has positive, significant, and broad-reaching implications that will speed the development and delivery of safe and effective innovations that will improve the lives and health of Americans.

• Dec 2022: Issued Report on Risks and Benefits to Health of Non-device Software Functions, describing the overall positive impact of these non-device software functions that FDA does not regulate on patient safety and describing best practices to promote safety, education, and competency.

• Dec 2022: Launched FDA's webpage on Augmented Reality and Virtual Reality in Medical Devices, delivering on feedback received at a Patient Engagement Advisory Committee (PEAC) meeting in July 2022, providing a list of medical devices that incorporate A/R and V/R across medical disciplines, and making it easier for users and developers to understand FDA's decision-making for these technologies.

• Oct 2022: Issued Spotlight: Digital Health Regulatory Science Research Opportunities to advance digital health regulatory science by encouraging discussions and stakeholder collaborations.

• Sep 2022: Launched the Digital Health Policy Navigator, which helps developers determine if their software may be regulated by FDA.

• Sep 2022: Issued Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff, providing a clear path to market for non-device AI/ML-based decision support tools and other products.

• Sep 2022: Issued The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings, concluding the pilot and completing an important first step towards identifying regulatory approaches to software that can better promote and protect public health. The report includes a number of lessons learned as well as two appendices that dive deeper into the types of objectives a new approach could better support and the types of data that may provide insight into those outcomes.

Deputy Director, Digital Health Center of Excellence

Nov 2019 – Apr 2023

• Identify and implement strategies to improve public health--and especially health equity--through digital health technologies that bring healthcare home, driving transformations of the healthcare delivery and research systems to more patient- and consumer-centered models.

• Supervised digital health activities within the organization, including the successful final phases and conclusion of the Software Pre-Certification Pilot Program (Pre-Cert), interactions with stakeholders and Advisory Committees, medical device user fee negotiation efforts (MDUFA), and consideration of product-specific scientific issues.

• In preparation for the founding of the Center of Excellence and throughout its initial phases, drove recruitment and retention initiatives that attracted and retained highly skilled digital health policy, technical, partnership, and medical experts, approximately doubling the size of the organization.

• Oversaw responses to approximately 800 internal and external policy and technical inquiries per year while improving response quality and decreasing typical time to respond by 80%.

• Nov 2021: Issued Content of premarket submissions for device software functions – Draft Guidance for industry and Food and Drug Administration staff.

• Oct 2021: Issued Good Machine Learning Practice for medical device development: Guiding principles, a collaborative effort between FDA, Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA).

• Oct 2021: Launched the Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices List, which helps stakeholders more easily locate and better understand FDA decisions related to these technologies.

• Jan 2021: Issued Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD) action plan.

Diagnostics Expert, COVID-19 Response

Mar 2020 – Jul 2020

• Led FDA’s participation in the US Government’s independent evaluation of serology tests with the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC). This first-of-a-kind effort to provide fast and trustworthy data generated directly by the US Government to support regulatory decisions for in vitro diagnostic testing has resulted in more than 30 devices becoming available to the public, including at the point of care. It has supported FDA’s regulatory decisions for more than 100 devices, and it has helped to ensure that high volume tests already on the market continue to provide accurate results. Built a statistical analysis pipeline that automatically analyzed the results of all evaluations to generate full evaluation reports and line data files. Coauthored the evaluation reports. Established a process for integrating the program with openFDA to provide evaluation results to the public via both a web page and an Application Programming Interface (API) after regulatory decisions have been made.

• Briefed the FDA Commissioner, the Department of Health and Human Services (HHS) Deputy Chief of Staff for Policy, congressional oversight committee staff, and the press on serological testing.

• Drafted strategy documents provided by the FDA to the Office of the Vice President and other US Government stakeholders, including a document related to ensuring adequate serology testing quality and capacity as well as a document on testing strategies and how the prevalence of a disease or condition impacts the clinical utility of a diagnostic test.

• Authored and maintained FDA’s web page on EUA Authorized Serology Test Performance to accurately, accessibly, and objectively convey complex scientific and statistical concepts and data to the public.

• Supported other aspects of the government’s response to the pandemic, including shortage mitigation and management, stakeholder engagement, and comparative performance analyses of nucleic acid and antigen tests for SARS-CoV-2.

Director, Division of Program Operations and Management

CDRH Office of In Vitro Diagnostics and Radiological Health
Apr 2018 – Nov 2019

• Led approximately 30 employees providing policy and operations support to scientists and engineers regulating diagnostic medical devices and software, radiation therapy devices, and electronic products that emit radiation, such as microwaves, lasers, and cell phones.

• Managed the office’s combined payroll and operating budget of approximately $60M.

• Overhauled the Third Party Premarket Review Program, enabling the review of medical technologies by non-federal organizations. Successfully negotiated user fees to provide $14M to support and improve the program through 2022. Informed the development of a legislative provision to increase FDA’s authority and autonomy to determine what devices are appropriate to include in the program. Interacted with key Congressional staff members and successfully built support for the provision, which was included in the FDA Reauthorization Act of 2017.

• Sep 2019: Led the office's contributions to Policy for device software functions and mobile medical applications – Guidance for industry and Food and Drug Administration staff, which superseded the February 9, 2015 and September 25, 2013 versions that I also helped draft.

• Sep 2019: Led the office's contributions to Medical device data systems, medical image storage devices, and medical image communications devices – Guidance for industry and Food and Drug Administration staff, which superseded the February 9, 2015 version that I also helped draft.

• Sep 2019: Led the office's contributions to Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act – Guidance for industry and Food and Drug Administration staff.

Deputy Director, Division of Program Operations and Management

CDRH Office of In Vitro Diagnostics and Radiological Health
Jul 2014 – Apr 2018

• Oversaw policy and operations work across the full range of medical device regulatory programs for in vitro diagnostic devices and radiology devices.

• Led team to develop innovative regulatory approaches for overseeing medical devices that use artificial intelligence, computer vision, wearable consumer sensors (e.g., smart-watches), and other novel digital health technologies. Helped negotiate five years of user-fee funding for a centralized Digital Health Program in the FDA.

• Provided technical assistance on the software provisions of the 21st Century Cures Act while it was under consideration in committee. Oversaw key implementation activities.

• Dec 2017: Led the office's contributions to Clinical and patient decision support software – Draft Guidance for industry and Food and Drug Administration staff.

• July 2014: Led the office's contributions to The 510(k) program: Evaluating substantial equivalence in premarket notifications – Guidance for industry and Food and Drug Administration staff. This working group received a CDRH Special Recognition Award. I proposed and developed the updates to the decision-making flowchart introduced in this guidance.

Public Health and Policy Analyst

Division of Program Operations and Management
CDRH Office of In Vitro Diagnostics and Radiological Health
Nov 2012 – Jul 2014

• Established and led the office’s initiative to develop strategies to ensure safety in digital health and medical device software.

• Oversaw all office determinations of whether or not products met the legal definition of a medical device and prioritized related enforcement actions.

• Led the Division of Radiological Health’s review of a high-profile recall using mechanical engineering, radiological device, and policy expertise.

• Oversaw the successful execution of multi-million-dollar IT contracts for the Center.

Reviewer, Artificial Pancreas Project

Division of Chemistry and Toxicology Devices
CDRH Office of In Vitro Diagnostics and Radiological Health
Temporary Assignment from Jul 2012 – Nov 2012

• Developed policies and supported premarket reviews and enforcement prioritization activities for autonomously controlled artificial pancreas device systems.

• Evaluated the safety of experimental software for use in clinical trials.

Policy Advisor

CDRH Office of the Center Director
Temporary Assignment from Apr 2012 – Jun 2012

• Developed policies and procedures with a focus on premarket medical device programs.

• Prepared information for the Federal Register in support of FDA’s ban on powdered latex gloves.

• Performed initial analysis for FDA’s future Accessory Devices Policy.

• Provided technical assistance for the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA).

Mechanical Engineer and Lead Reviewer

Division of Radiological Health
CDRH Office of In Vitro Diagnostics and Radiological Health
Apr 2009 – Nov 2012

• Successfully brought controversial scientific issues to resolution during a period of elevated public scrutiny. Led reviews of the first cell-phone and tablet based mobile apps for diagnostic radiology, the first ultrasound elastography system with numeric output, the first MRI-guided radiation therapy system, and novel high-resolution displays for digital mammograms.

• Assisted the Securities and Exchange Commission (SEC) with an investigation that led to fraud charges and a consent decree against a medical device manufacturer.

• Led the review and clearance of more than 75 radiation therapy devices, advanced diagnostic imaging systems, robotic biopsy devices, body composition analyzers, and other devices. Prevented several unsafe and ineffective devices from reaching the market.

• Dec 2011: Coordinated and made significant contributions to radiological device policy aspects of Enforcement policy for premarket notification requirements for certain in vitro diagnostic and radiology devices – Guidance for industry and Food and Drug Administration staff. This working group received an FDA Outstanding Service Award.

• Aug 2010: Made significant contributions to CDRH preliminary internal evaluations – Volume I: 510(k) Working Group preliminary report and recommendations. This working group received a CDRH Group Recognition Award.

ATK Space Systems (now Northrop Grumman Space Systems)

Beltsville, MD
Various Positions (see below)
May 2007 – Apr 2009

Mechanical Design Engineer

Aug 2008 – Apr 2009

Engineered two Crew Aids and Tools successfully used on a spacewalk to repair and upgrade the Hubble Space Telescope Imaging Spectrograph in May 2009.

Mechanical Design Co-Operative Engineering Student

Part time from May 2007 – Aug 2008

Supported the Hubble Space Telescope Servicing Mission 4.

Recognition and Awards

U.S. Food and Drug Administration University of Maryland, College Park Other

Education

University of Maryland, College Park

B.S. in Mechanical Engineering with Honors
Sep 2005 – Aug 2008

Professional Societies and Affiliations

• Federal Executive Institute Alumni Association (FEIAA)

• American Society of Mechanical Engineers (ASME)

• Institute of Electrical and Electronics Engineers (IEEE)

• American Society for Quality (ASQ)

• Regulatory Affairs Professionals Society (RAPS)

Additional Skills, Training, and Education

• Experienced in R / tidyverse / shiny, docker / docker-compose, MATLAB, Visual Basic for Applications (VBA), Java (Android application development), Python, HTML / JavaScript / CSS, Visual Basic, MacOS, Linux, Windows 10, iOS, and Android

• Learning the Rust programming language

• Federal Executive Institute Leadership for a Democratic Society Program (LDS-449, Fall 2018)

• Certified as an American Society for Quality Certified Quality Auditor (ASQ-CQA) (Jun 2016 – Jun 2020) and Six Sigma Green Belt (ASQ-CSSGB)

• “Executive Leadership Program” (Graduate School USA, 2011–2012)

• Graduate-level coursework in medical robotics

• Advanced coursework in material properties, mechanical failure analysis, computerized optimization of mechanical systems design, and control systems engineering

Open Source Software

1. Brendan O’Leary. mdufa: Structured Data on FDA’s Medical Device User Fee Program Performance. R Package, January 2024.

2. Brendan O’Leary. ctdl: Clinical Trials Downloader. R Package, March 2023.

3. Brendan O’Leary. fdadata: Access public information from the FDA website. R Package, October 2022.

4. Brendan O’Leary. dxr: Diagnostic product evaluation in R. R Package, May 2022.

Publications and Presentations

Publications

1. Ligia A. Pinto, Ribhi Shawar, Brendan O’Leary, Troy J. Kemp, James Cherry, Natalie Thornburg, Cheryl N. Miller, Pamela S. Gallagher, Timothy Stenzel, Brittany Schuck, S. Michele Owen, Marina Kondratovich, Panayampalli S. Satheshkumar, Amy Schuh, Sandra Lester, M. Cristina Cassetti, Norman E. Sharpless, Steven Gitterman, and Douglas R. Lowy. A trans-governmental collaboration to independently evaluate SARS-CoV-2 serology assays. Microbiology Spectrum, 10(1):e01564–21, January 2022.

2. Ribhi Shawar, Brendan O’Leary, Troy J. Kemp, James Cherry, S. Michele Owen, Pamela S. Gallagher, Natalie Thornburg, Marina Kondratovich, Subbian Satheshkumar Panayampalli, Amy Schuh, et al. A trans-governmental collaborative effort to independently evaluate SARS-CoV-2 serology assays using well-characterized sample panels. In Open Forum Infectious Diseases, volume 7, pages S851–S851. Oxford University Press US, 2020.

3. Aldo Badano, Wei-Chung Cheng, Brendan O’Leary, and Kyle J Myers. Cutting-edge technology: Part II: Pre-clinical assessment of medical displays for regulatory evaluation. Information Display, 27(4):28, 2011.

4. Steve Caperna, Christopher Cheng, Junghee Cho, Victoria Fan, Avishkar Luthra, Brendan O’Leary, Jansen Sheng, Andrew Sun, Lee Stearns, Roni Tessler, Paul Wong, and Jimmy Yeh. A navigation and object location device for the blind. Gemstone Undergraduate Team Research, 2009.

5. Christopher Cheng, Brendan O’Leary, Lee Stearns, Steve Caperna, Junghee Cho, Victoria Fan, Avishkar Luthra, Andrew Sun, Roni Tessler, Paul Wong, Jimmy Yeh, Bobby Bobo, Rama Chellappa, and Cha-Min Tang. Developing a real-time identify-and-locate system for the blind. Presented at the Workshop on Computer Vision Applications for the Visually Impaired. Presented at the Workshop on Computer Vision Applications for the Visually Impaired, Marseilles, France, 2008.

Presentations

1. Brendan O'Leary. Predetermined Change Control Plans (PCCPs): Strategic and tactical applications to AI and more. Presented at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting, May 2024.

2. Caroline Popper, Gary Loeb, and Brendan O'Leary. Balancing the Law with Human and Artificial Intelligence in Medical Practice. A presentation and panel discussion at the 25th Annual Emerging Issues in Healthcare Law Conference hosted by the American Bar Assoication's Health Law Section, April 2024.

3. Julia Harris, Caroline Pearson, Devin Mann, Ateev Mehrotra, Brendan O'Leary, Cara Tenenbaum, and Anuja Vaidya. The Future of Remote Patient Monitoring. A panel discussion hosted by the Bipartisan Policy Center and the Peterson Center on Healthcare, January 2024. A recording of this discussion is available online.

4. Brendan O'Leary. Regulatory considerations for digital surrogate endpoint response biomarkers. A presentation at the EverythingALS Digital Biomarkers Summit, July 2023. This presentation has been adapted into a blog post.

5. Craig Coombs, Zane Liu, and Brendan O'Leary. Digital Health. A panel discussion at the 2023 MDMA FDA Forum, March 2023.

6. Brendan O'Leary. FDA's Progress on Digital Health. A presentation at the DiabetesMine Innovation Days D-Data Exchange, November 2022.

7. Brendan O'Leary, Thierry Sirdey, and Maggie Henkin. Software Products with Multiple Functions. A presentation and panel discussion at the APEC Roundtable Dialogue on Global Regulatory Convergence for Medical Devices & Accelerating Digital Health Regulatory Convergence in the Asia-Pacific, November 2022.

8. Brendan O'Leary, Cassie Scherer, and Jaesoon Choi. Software Change Management. A presentation and panel discussion at the APEC Roundtable Dialogue on Global Regulatory Convergence for Medical Devices & Accelerating Digital Health Regulatory Convergence in the Asia-Pacific, November 2022.

9. Alexander Fleming, Alberto Gutierrez, Yiduo Wu, Zane Arp, Bradley M. Thompson, and Brendan O’Leary. Regulation of Diabetes Technology. A presentation and panel discussion at the Diabetes Technology Meeting, November 2022.

10. Diane Johnson, Yuri Maricich, Brendan O’Leary, Cybil Roehrenbeck, and Cassie Scherer. Artificial Intelligence in Medical Devices: Post Pandemic Implications. A panel discussion at The MedTech Conference, October 2022. This panel discussion received media coverage from Fierce Biotech and MedicalDesign & Outsourcing.

11. Srinath Adusumalli, Don Cutlip, Jodi Akin, Ami Bhatt, Ian Meredith, and Brendan O’Leary. Moving Primary Care from the Clinic to the Pharmacy/Retail Store: Impact on the Medical Device Ecosystem. A panel discussion at the Dartmouth Device Development Symposium, October 2022.

12. Robert Kazmierski, Adam Jacobs, Aaron V. Kaplan, Lauren Baker, Brendan O’Leary, Jessica Paulsen, and Sam Surette. Medical Device-Smart App Driven Management: Navigating new Landscapes Leveraging AI & Machine Learning, addressing cybersecurity concerns: A Fictitious Case Study. A panel discussion at the Dartmouth Device Development Symposium, October 2022.

13. Brendan O’Leary. Digital therapeutics regulation. Presented at the DTx East conference, September 2022. This presentation received media coverage from STAT and pharmaphorum.

14. Jeffrey Shuren, Michellle Tarver, Brendan O’Leary, Daniel Caños, and Edward Margerrison. CDRH town hall. A panel discussion at the Medical Device Innovation Consortium (MDIC) Annual Public Forum, September 2022.

15. Brendan O’Leary, Anindita Saha, Amy McDonough, Cassie Scherer, and Heather Benz. Digital health technologies for healthcare: Advancing innovation and regulatory science through global collaboration. A panel discussion at the Medical Device Innovation Consortium (MDIC) Annual Public Forum, September 2022.

16. Johan Ordish, Brendan O’Leary, Lin Anle, David Hau, Rolf Oberlin Hansen, and David Wotton. Current regulatory approaches to AI and medical devices. A panel discussion at the International Medical Device Regulator’s Forum (IMDRF) and Global Medical Technology Alliance (GMTA) Joint Workshop, September 2022.

17. Brendan O’Leary. US FDA’s perspective: Artificial intelligence and machine learning – Can "one size" fit all? Presented at the International Medical Device Regulator’s Forum (IMDRF) and Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association Joint Workshop, September 2022.

18. Brendan O’Leary, Martin Meyer, Vince McCauley, Robert Turpin, David Hau, and David Wotton. Artificial intelligence and machine learning: Can "one size" fit all? A panel discussion at the International Medical Device Regulator’s Forum (IMDRF) and Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association Joint Workshop, September 2022.

19. Brendan O’Leary. Considerations and possible framework for software as a medical device risk categorization. Presented at the Latin America Forum on Conformity Assessment for Medical Devices – SaMD, August 2022.

20. Sven Jungmann, Anne Sophie Geier, Tonya N. Dowd, and Brendan O’Leary. Digital health for all: Scaling digital across borders. A panel discussion at Health For All: A Digital Health Forum from G4A, June 2022.

21. Brendan O’Leary, Damien McPhillips, Szymon Perkowski, and Aaron Dunbar. FDA Digital Health Software Precertification Pilot (Pre-Cert). Presented at the AFDO/RAPS Healthcare Products Collaborative 2022 MedCon Conference, May 2022. This presentation received media coverage from the Regulatory Affairs Professional Society.

22. Brendan O’Leary. FDA regulation of AI/ML-enabled medical devices. Presented at the 2022 Medical Device Software Development Summit, May 2022.

23. Brendan O’Leary. Digital Health Overview. Presented at the Consumer Technology Association (CTA) Health Division FDA Working Group, May 2022.

24. Reena Philip, Alain Silk, Kelly Oliner, Kris Roth, and Brendan O’Leary. Implementing Least Burdensome: From principles to practice. Presented at the FDA-Industry IVD Roundtable, May 2018.

25. Brendan O’Leary. A brief overview of the 3rd Party Review Program. Presented at the Spring 2018 Meeting of AdvaMedDx, May 2018.

26. Brendan O’Leary. A brief update on the 3rd Party Review Program. Presented at the Spring 2018 Regulatory Policy and Strategy Meeting of the Medical Imaging Technology Alliance (MITA), April 2018.

27. Danelle Miller and Brendan O’Leary. 21st Century Cures Act – Key highlights and implementation activities. Presented at the FDA-Industry IVD Roundtable, June 2017.

28. Brendan O’Leary. New IVD work instructions clarify cybersecurity review practices. Presented at the Office of In Vitro Diagnostics and Radiological Health All-Hands Meeting, May 2017.

29. Brendan O’Leary. Strengthen the 3rd Party Premarket Review Program. Presented at the FDA-Industry Discussions on MDUFA IV Reauthorization, January 2016. Meeting minutes are available here.

30. Brendan O’Leary. Scale the CDRH Digital Health Program. Presented at the FDA-Industry Discussions on MDUFA IV Reauthorization, January 2016. Meeting minutes are available here.

31. Jeremy Logue, Brendan O’Leary, and Sara Aguel. Center for Devices and Radiological Health premarket IT systems overview. Presented at the FDA-Industry Discussions on MDUFA IV Reauthorization, October 2015. Meeting minutes are available here.

32. Brendan O’Leary. New cybersecurity guidance – What it means for industry. Presented at the FDA-Industry IVD Roundtable, November 2014.

33. Brendan O’Leary. Draft mobile medical applications guidance. Presented at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting, April 2013.

34. Geoffrey Clapp and Brendan O’Leary. Complying with federal regulations. Presented at the Office of the National Coordinator for Health Information Technology Health Tech Innovator Workshop, October 2012.