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Technology and Regulatory Affairs — 2018

A Clear Path for Medical Progress  

Ensuring regulatory processes for medical technology that are efficient, predictable and transparent is essential for innovation to thrive and patients to benefit, and is the core focus of AdvaMed’s Technology and Regulatory Affairs department (T&R).  


In 2018, the department worked to ensure effective implementation of important provisions of the FDA Reauthorization Act, the latest medical device user fee agreement, and the 21st Century Cures Act. The T&R department also achieved a number of significant regulatory policy successes during the year, including: 

21st Century Cures 

AdvaMed feedback from a member survey was included in a June FDA report to Congress updating the progress of staff training on appropriate use of the “least burdensome” principle for regulatory decision making. The report showed agency progress in the application of least burdensome principles, and that company experiences are improving, though some opportunities for improvement remain. 

User Fee Agreement 

In August, FDA finalized a voluntary program that permits the reporting of device malfunctions on a summary, quarterly basis for the vast majority (about 88 percent) of device types. The move, which is in line with requirements of the latest FDA user fee agreement (MDUFA IV) and related AdvaMed advocacy efforts, will provide significant compliance resource savings for member companies.        

FDA Reauthorization Act  

AdvaMed worked to advance FDA release in August of a Federal Register notice that will downclassify a number of medical device accessories – and thus streamline their approval and clearance, and reduce associated regulatory burdens – consistent with provisions of the 2017 FDA Reauthorization Act. The agency’s proposal ensures that risk classification decisions for device accessories will be made independent of the parent medical device. 

Cybersecurity 

In September, AdvaMed’s Board approved the formation of a medtech Information Sharing and Analysis Organization (ISAO). The AdvaMed ISAO will enable the medtech industry to share cybersecurity information in a safe, secure and legally protected manner. Creation of the ISAO was among a range of T&R activities during the year aimed at implementing the association’s broader cybersecurity principles.  

Global Harmonization 

AdvaMed worked with the International Medical Device Regulators Forum (IMDRF) throughout the year to advance key principles for overseas implementation of unique device identifiers (UDIs) and help ensure a harmonized approach to UDI across borders. IMDRF also accepted an AdvaMed proposal to create a new work group – including experts from three AdvaMed member companies – to develop standardized principles on appropriate use of clinical evidence.