Mobile Apps as Medial Devices
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Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management.
Others are targeted to health care providers as tools to improve and facilitate the delivery of patient care. These software devices include products that feature one or more software components, parts, or accessories, as well as devices that are composed solely of software.
Certain software functions / mobile apps that are device functions can pose potential risks to public health, and these are the subject of FDA concern and focused regulation. Mobile medical apps, as defined here, include only those mobile apps that:
Why you should Attend:
- Meet the definition of a device
- Intended to be used as an accessory to a regulated medical device
- Intended to transform a mobile platform into a regulated medical device. What are they as defined by the FDA, what are not? Requirements? Cybersecurity, documentation and validation requirements
FDA refers to software functions that are device functions as "device software functions."
These may include "Software as a Medical Device (SaMD)"and "Software in a Medical Device (SiMD)". If a software function that meets the definition of a device is deployed on a mobile platform, it may be referred to as a "mobile medical app.
"These new technologies use terms such as "mobile medical apps," "mobile medical app manufacturers,""device software functions,"and "device software function manufacturers", and are not always specific to whether the the function is deployed on a mobile platform or other general purpose-computing platform.
What are the FDA definitions and regulatory expectations? What is also required for effective and real world software verification and validation in such use envionments? This discussion will focus on what is and what is not recognized as a mobile app for regulation as a medical device by the US FDA. Cybersecurity, CGMP, 21 CFR Part 11 and submission consideratoins will be discussed as well.
Areas Covered in the Session:
Who Will Benefit:
- Mobile Health Apps / Functions - What are they?
- SaMD and SiMD
- FDA's Functionality vs. Platform enforcement approach
- Intended Use
- Software functions that are, or are NOT, a "device"
- FDA's regulatory approach; Examples
- Design, manufacturing and additional requirements
- Cybersecurity requirements
- Validation and unique documentation requirements
- Senior management in Devices, Combination Products
- QA / RA
- Software development, programming, documentation, testing teams
- Consultants; others tasked with product, process, electronic records software V&V responsibilities
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.