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 […]
Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, […]
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 While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products […]
On October 1 the US Food and Drug Administration (FDA) issued final guidance regarding cybersecurity for medical devices. The FDA guidelines urge device manufacturers to include safety controls on devices to prevent cyber threats and recommend manufacturers outline the necessary steps that will be taken if their devices are found to […]
Yesterday, the U.S. Food and Drug Administration (FDA) released five documents outlining the FDA’s current policies regarding compounded drug products for human use. All of the documents are available through the FDA’s website. Tuesday’s issuances were part of the FDA’s continued implementation of the Drug Quality and Security Act (DQSA), […]
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.
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 […]