The Role of FDA in Health Care Software Regulations and Development
This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device.
Why should you Attend: Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing process (not necessarily a medical device, but like all device class II and III, manufacturing elements, subject to QSR’s), or 2) software that is a component or accessory of some Class III or Class II medical device (Itself a medical device, per FDA guidance).
Also, with the proliferation of numerous applications in the Health Care, some developers are still unsure whether or not their product is a medical device.
Finally, even though some applications can meet the definition of a medical device, Guidance indicates that FDA is not going to regulate them. Can you tell which is which?
Areas Covered in the Session:
- Who regulates software and why
- How to tell if the software you are developing is a medical device
- What does “enforcement discretion” mean and how does it apply to software
- What are the expectations for software that’s an integral part of a device
- What about software that is offered to analyze signal from a medical device, but is not a part of the device, has a different manufacturer and seller? (e.g., sequencer raw data from manufacturer A, can be analyzed by software from either software seller B or C, and translated using different interfaces from either B or C to the local LIMS
- What about software used in the manufacturing process but not sold
- Who is enforcing HIPAA, Patient privacy, for device software?
- And what does Part 11 have to do with my software?
Who Will Benefit:
- Code Developers working on Medical Applications
- Regulatory Affairs Associates
- Health Care Software Marketing Associates
- QA associates for firms that are developing/revising Medical Software
They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams.
Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC.
Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled "Due Diligence Points to Consider" in the "Expert's Guide to Healthcare Product Due Diligence" published by FDLI.
Ms. Longwell holds a bachelor's degree in Chemistry from San Francisco College for Women (now USF), a Master's degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).