Regulatory Strategies for Marketing and Selling a Mobile Medical Device and Medical Applications (Apps) for Use on Smartphones and Similar Mobile Devices

Website https://www.compliance2go.com/product/?pid=CP2014-267 | Edit Freely

Category Medical Device

Deadline: March 12, 2014 | Date: March 12, 2014

Venue/Country: houston, U.S.A

Updated: 2014-02-14 14:40:31 (GMT+9)

Call For Papers - CFP

FDA recently published Guidance on how it intends to regulate Mobile Medical Devices and Medical Apps moving forward. An understanding of this Guidance and the regulatory evolution up to the publication of the rule is essential for any company considering the use and promotion of a proprietary App. Failure to understand the Guidance and FDA’s stated position could put a company at risk for Agency enforcement action. Confirming this risk is the fact that FDA and the Federal Trade Commission (“FTC”) have both already taken enforcement action against unapproved and misleading products and Apps in the market.

Some mobile medical products and Apps are regulated as medical devices. Companies are developing, introducing and relying on such devices for a variety of reasons that include helping consumers manage their own health and wellness, and helping health care providers improve and facilitate patient care.

This webinar is designed to provide attendees with an introduction to FDA’s oversight of certain medical and healthcare-related Apps designed for use on smartphones and other mobile computing platforms.

In July 2011, FDA published a draft Guidance outlining the small number of mobile apps the Agency plans to regulate?those included mobile medical devices and Apps are items that could present a potential risk to patients if they and especially the App fails to work as intended. As explained in that July 2011 Guidance document, FDA proposed to oversee those devices and App that are (1) used as an accessory to an FDA-regulated medical device, or (2) transform a mobile platform into a regulated medical device.

This webinar will focus on FDA’s Regulation of Mobile Medical Devices and Apps, and is aimed at helping attendees distinguish between those apps requiring FDA 510(k) clearance and those needing a PMA.

The presenter who has himself already gotten such devices through the Agency’s 510(k) clearance process and is currently working with a company on another App-related project, will provide recommended strategies for successfully getting your mobile medical devices and App through FDA and onto the market.

Why you should attend

This webinar is intended to be a practical training program for companies currently selling or planning to sell Mobile Medical Applications or “Apps”. The class is designed to teach attendees the skills and strategies they need to design, develop, test and commercialize such an App in the United States.

In September 2013, FDA published its Final Guidance detailing how it intends to regulate mobile devices and Medical Apps. This recently published Guidance Document and its included requirements will be discussed, and time will be devoted to understanding how it might affect not only a company pursuing its first App but also that company pursuing its 5th App..

Focusing on FDA’s regulation of mHealth devices and Mobile Medical Apps, attendees will also learn how to distinguish between those Apps requiring FDA 510(k) clearance and those needing Pre-Market Approval or a “PMA”. The presenter has already successfully shepherded an App through the 510(k) Notification clearance process and is currently working on obtaining the clearance of another such device. During the webinar, he will share his experiences and offer recommendations for identifying appropriate predicates, conducting performance testing, preparing a risk assessment for the device, performing software validation and satisfying the requirements for wireless security. Additionally, the decision of whether to go Rx or OTC will be discussed.

Areas Covered In the Seminar

- FDA’s recently published 2013 Guidance Document focused on how the Agency intends to regulate mobile medical devices and Apps moving forward

- The criteria for distinguishing between those Apps which are subject to FDA oversight and those which are not.

- Determining when a 510(k) Notification vs. a Premarket Approval is needed to go to market

- Discussion of the responsibilities of a regulated medical device company.

- The July 2011 Mobile Medical App Draft Guidance Document

- What regulatory requirements must a manufacture comply with to market a regulated app

- Identification of application FDA regulations, guidance documents and other relevant documents

Who will benefit:

Regulatory Affairs Professionals, Managers, Consultants, Scientists, Research Analysts, State Policy Officials, Insurers focusing on Representations & Warranties Insurance; Investment Analysts; Venture Capitalists.

Medical device and Biotech Companies, Start-ups, Foreign Device Manufacturers, Importers, Device Reprocessors; Mobile and Smartphone Companies; the Telecom Industry

Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance