Mobile Devices – Eisner Safety Consultants

Boston Scientific CRV Launches iPad App CardioTeach™

leoeisner — Fri, 11 Nov 2011 07:29:45 +0000

From MedicalDeviceSummit on Nov 10, 2011 – ‘The new iPad app CardioTeach has been touted as industry’s first at helping doctors communicate heart disease and treatment options to patients.’

There is a video demonstration of the CardioTeach iPad app

Apple AppStore iPad link for the CardioTeach

FDA Issues Draft Guidance doc on Mobile “App’s”

leoeisner — Wed, 03 Aug 2011 23:51:38 +0000

On July 21, 2011 the FDA released a draft Guidance document on Mobile “App’s”. There is a 90 day period to submit comments for consideration. (See details on web link for draft guidance).

The draft guidance document states in section IV: “This guidance explains FDA intentions to apply its regulatory requirements to a subset of mobile apps. This subset, which we are calling mobile medical apps as defined in section III (definitions), includes only those that meet the statutory definition of a device; and either:

are used as an accessory to a regulated medical device;
or transform a mobile platform into a regulated medical device.

This guidance does not specifically address wireless safety considerations, classification and submission requirements related to clinical decision support software, or the application of quality systems to software. The FDA intends to address these topics through separate guidance(s).”

Also, the draft guidance details a long list of app’s that don’t fall under this draft guidance document.

Joint FDA/FCC public mtg 7/26-27 – Enabling Convergence of Communication & Medical Systems

eisnersafety — Fri, 18 Jun 2010 18:27:23 +0000

Joint FDA/FCC public meeting July 26 & 27, 2010 – Enabling Convergence of Communication & Medical Systems: Update Regulatory & Info Processes http://ht.ly/20oMz

Summary: The FDA and the FCC are jointly sponsoring a public meeting entitled “Enabling the Convergence of Communications and Medical Systems: Ways to Update Regulatory and Information Processes.”The purpose of this meeting is to identify the challenges and risks posed by the proliferation of new sophisticated medical implants and other devices that utilize radio communications to effectuate their function, as well as challenges and risks posed by the development and integration of broadband communications technology with healthcare devices and applications.

Dates and Times: The public meeting is scheduled for July 26 and 27, 2010, from 8 a.m. to 5:30 p.m. Persons interested in attending and/ or participating in the meeting must register by 5 p.m. EDT on July 19, 2010. Submit either electronic or written comments related to the agenda, by 5 p.m. EDT on June 25, 2010.

Location: The public meeting will be held at the FCC Commission Meeting Room, 445 12th St. SW., Washington, DC 20554

Contact Persons: Bakul Patel, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 3543, Silver Spring, MD 20993, 301-796-5528, email: bakul.patel@fda.hhs.gov; or Bruce Romano, Federal Communications Commission, 445 12th St. SW., rm. 7-C140, Washington, DC 20554, 202-418-2470, email: bruce.romano@fcc.gov.

Registration and Requests for Oral Presentations: Registration requests must be received by 5 p.m. EDT on July 19, 2010. Interested persons may register by emailing FCC-FDAMeeting@fcc.gov