Background of the Medical Software Functions Exclusion Most of those in the industry do not question whether the FDA has the authority to regulate software that qualifies as a device. However, there are many intricacies in the definitions of the 21st Century Cures Act – which, in 2016, amended the definition of medical devices in...Read More

The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems.  The idea is that the Verily watch would be worn similar (or as!) a consumer device...Read More

On Dec. 8, 2017 FDA released a Draft guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”. This guidance dsicusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or...Read More

An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...Read More

FDA published a draft guidance “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff” dated 10/25/17. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for certain medical devices...Read More

FDA issued a draft list of Class II Medical Devices exemptions from the 510(k) premarket notification requirements to comply with the 21st Century Cures Act. Note that 884.1630 is NOT exempt if it contains software for image analysis or smartphone use. Other software-related sections of note are 86.2570 and 882.1470.Read More

What the 21st Century Cures Act Means for Software Manufacturers The 21st Century Cures Act (“Cures Act”), was signed into law by the President on December 13, 2016 (Public Law No. 114-255). This article focuses on section 3060 of the new law; namely “Clarifying Medical Software Regulation.” Other sections of the act address medical devices...Read More

Hyman, Phelps & McNamara posted a great summary of the impact of the 21st Century Cures Act in regards to general provisions affecting medical device regulation. They also provide links to summaries of other provisions of the act for standalone software (also posted on softwarecpr.com), and drugs and biologics impact.Read More

The law firm of Hyman Phelps and McNamara posted their summary of the impact on this Dec 13, 2016 US Law the 21st Century Cures Act. at the link provided. Section 3060 addresses standalone software and exempts some software from regulation as a medical device. They also provide links to summaries of other provisions of...Read More

http://blogs.fda.gov/fdavoice/index.php/2014/06/fda-encourages-medical-device-data-system-innovation/Read More