Category: Medical Devices

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

COOLEY ALERT Published: FDA Issues Final Guidance Regarding Mobile Medical Applications

We informed you earlier this week that the U.S. Food and Drug Administration’s (“FDA”) long awaited final guidance on mobile medical applications was released.  We have now published a Cooley Alert that analyzes the final guidance in greater detail.  The Cooley Alert is available at: http://www.cooley.com/FDA-issues-final-guidance-regarding-mobile-medical-applications.

FDA Issues Final Guidance Regarding Mobile Medical Applications

The U.S. Food and Drug Administration (FDA) announced today the issuance of its final guidance regarding mobile medical applications, defined by FDA as software programs that run on mobile communication devices and perform the same functions as traditional medical devices.  This final guidance finalizes draft guidance that was issued by the FDA on […]

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

Regulatory Uncertainty as FDA Draft Guidance on Mobile Medical Applications Reaches its Two-Year Anniversary

Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology.  Two years following the FDA’s […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]