News & Updates
Webinar: Mobile Medical Apps: FDA Regulation and Products Liability Implications October 14, 2013
Sign up today for a free webinar on Mobile Medical Apps: FDA Regulation and Products Liability Implications
The webinar will be held from 2-3 p.m. (EDT) Wednesday, October 23, 2013. Click here to register.
This webinar will address:
- An overview of the FDA’s final guidance on MMAs;
- Predictions for the level of oversight the FDA will exert over MMAs;
- How the traditional products liability theories of design defect, warning defect, and failure to warn, operate in the MMA context; and
- Ways in which creators of MMAs can best insulate themselves from products liability risks.
As the newest frontier in medical devices, mobile medical apps (MMAs) are growing rapidly in number, popularity, and diversity of use. Their proliferation can largely be attributed to the relative ease with which they have been brought to market, most having required little initial investment and having skipped the regulatory hurdles more traditional medical devices must wade through—at significant expense in time and money—to enter the marketplace. Some of this may change with the advent of the FDA’s final guidance on MMAs, which clarifies when a mobile app constitutes a medical device and delineates which apps will be subject to the greatest regulatory oversight by the Agency. In addition to constituting a relatively new area of regulation, MMAs also pose new products liability risks. For example, when MMAs function to replace or augment the role of traditional healthcare delivery systems (e.g., doctors), they may be especially vulnerable to products liability.
Please contact Maggie Bibb at 703-652-1317 with questions.