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2019 Technology and Regulatory Affairs

Lighting A Path for Innovation

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 2019, the department worked to ensure effective implementation of key provisions we supported as part of the medical device user fee agreement (MDUFA IV), the 21st Century Cures Act, as well as medical device regulatory reforms included in the FDA Reauthorization Act. The department achieved a number of significant regulatory policy successes during the year, including:

User Fee Agreement

AdvaMed advocacy was instrumental to ensuring FDA is on track to meet its performance goals for average time to decisions for both 510(k) and PMA submissions, and ahead of the first-time performance goal for review of de novo submissions. T&R worked with the consultant FDA hired to perform a MDUFA IV independent assessment, reviewing agency accountability measures to ensure our priorities will be covered. The association also held several brainstorming sessions with members to prepare for the start of MDUFA V negotiations in 2020.

21st Century Cures

AdvaMed provided feedback to FDA on numerous revised guidance documents related to software development to ensure appropriate alignment with requirements of the 21st Century Cures Act, including guidance related to clinical decision support.

Cybersecurity

During the year, AdvaMed continued the launch of the MedTech Information Sharing and Analysis Organization (ISAO), approved by the Board in late 2018. This included creation of ISAO operating documents, such as a code of conduct and non-disclosure agreement. The ISAO enables the medtech industry to share cybersecurity information in a safe, secure and legally protected manner. Over two dozen cybersecurity professionals from AdvaMed membership have joined the ISAO to date. AdvaMed also submitted comments to FDA in 2019 on a revised draft cybersecurity guidance, and worked with the International Medical Device Regulators Forum to ensure an IMDRF draft cybersecurity guidance is in-line with AdvaMed’s cyber principles.

Global Harmonization

AdvaMed worked with the International Medical Device Regulators Forum to advance standardized principles and policies on appropriate use of clinical evidence, including through an IMDRF work group advocated by AdvaMed that includes experts from several of our member companies. During the year, AdvaMed also worked with the Asia-Pacific Economic Cooperation forum’s Regulatory Harmonization Steering Committee to advance regulatory convergence across the region through establishment of progress measures and additional centers of excellence in regulatory science training.