Tag: final guidance

FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]

All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness:  Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout.  While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products […]

FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC.  The Guidance is a tool created in collaboration with the FTC, the […]

FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015.   This guidance is a first for the FDA and comes as a product of negotiations with the medical device industry over Medical Device User Fee Amendments […]

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 […]