Tag: Medical device

Q3 GOVERNMENT SETTLEMENTS ROUND-UP: LIFE SCIENCES

The U.S. Department of Justice (DOJ) and other government enforcers announced a number of key settlements in the life sciences industry in July – September 2019. These settlements include: LIFE SCIENCES INDIVIDUALS/ ENTITIES SETTLEMENT DATE RESOLUTION KEY AREAS OF ENFORCEMENT Pharmaceutical company Sept. 26, 2019 $108M Deferred prosecution agreement Forfeiture […]

AdvaMed Code of Ethics Updated Effective January 1, 2020

The Advanced Medical Technology Association (AdvaMed) announced earlier this month the availability of an updated Code of Ethics on Interactions with U.S. Health Care Professionals (AdvaMed Code). The updated AdvaMed Code becomes effective January 1, 2020. According to AdvaMed, the AdvaMed Code was updated to make examples current, enhance user-friendliness, and address the evolving nature […]

FDA Releases Digital Health Guidance to Spur Innovation

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies.  By clarifying what is – and what is not – subject to regulation, this set of guidance could create significant opportunities for […]

Maine Enacts Gift Ban Law

Yesterday, An Act To Prohibit Certain Gifts to Health Care Practitioners became law in Maine without the signature of the Governor. 32 MRSA § 13759 prohibits licensed pharmaceutical and medical device manufacturers and wholesalers from providing a gift to a practitioner. Exceptions include: noncash items of minimal value that directly benefit the practitioner’s patients, […]

21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for […]

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  While not much has changed from the 2015 draft guidance, the number of mobile apps and general wellness products […]