More than two years after publishing a draft guidance document in which it proposed to regulate a broad swath of apps as medical devices, on Monday September 23, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.
Although the final guidance retains the basic framework of the draft guidance, it features several significant changes. In particular, the final guidance appears to narrow the scope of mobile apps that FDA intends to regulate as medical devices, and it expands the categories of apps that will be subject to enforcement discretion. At the same time, however, the final guidance leaves open several questions regarding how FDA intends to regulate apps that serve as accessories to other devices, as well as apps that do not clearly fall into the enforcement discretion categories.
The following presentation will provide an overview of the final guidance and highlight take-aways including:
- Outlining and understanding the scope of the regulation
- What are medical devices?
- What apps are regulated by FDA under its device authorities?
- What gray areas still exist?
- How can industry reduce the risk of FDA regulation?
- If an app qualifies as a mobile medical app, what steps should a company take?
Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Affairs
- Mobile Device
- Product Development
- Product Marketing
Chris Pruitt, Associate, Covington & Burling LLP
Christopher Pruitt is an associate in the firm’s Washington, DC office in the Food & Drug and Government Contracts practice groups. He has experience advising manufacturers of drugs, devices, food, and other products on a range of regulatory issues involving the Food & Drug Administration, including compliance, transactional, and enforcement matters. Mr. Pruitt has particular experience with legal and regulatory issues related to FDA regulation of medical device software, promotion in social media, in vitro diagnostics, regulation of clinical laboratories, and food safety. Mr. Pruitt also advises drug and device manufacturers of legal and regulatory obligations associated with selling products to the Federal Government.
Scott Danzis, Partner, Covington & Burling LLP
Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.