The subjects below relate to premarket, postmarket, and quality topics. They are dynamic and closely watched by regulators, industry, and other stakeholders. We engage in these subjects through written submissions, in‑person discussions, and other communication channels.
Safety is critical to the medical technology industry, and medical device manufacturers take seriously the need to continuously assess the security of their devices in a world where the risks evolve. The FDA has issued guidance documents on the issue for both pre- and post- market considerations, Congress has proposed various legislative items on the topic, and AdvaMed has issued foundational cybersecurity principles. In addition to these efforts, to enhance information sharing within the medical device community AdvaMed has launched the MedTech ISAO, which is open to AdvaMed members.
The FDA Software Precertification Pilot Program is informing the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to them. FDA’s envisions a future regulatory model that provides a more streamlined and efficient regulatory oversight model for software-based medical devices that are developed by manufacturers that demonstrate a robust culture of quality and organization excellence. AdvaMed’s software working group has and continues to engage with the agency on this effort.
Diagnostic Device Precertification
We support the value of innovative high-quality diagnostic tests and advocate for risk-based regulation of all diagnostics. Diagnostics tests provide vital information at every stage of patient care from detection and diagnosis of disease to advancing personalized medicine. The regulatory framework should be modernized to support innovation and keep the pace of the science.
As stakeholders work to support comprehensive diagnostic reform, modern approaches may include consideration of new approaches to help advance robust innovation and high quality diagnostic for patients.
As part of a risk-based approach, we support the concept of precertification for diagnostics to help promote innovator excellence and support patient access to accurate and high-quality diagnostics.
FDA CFQ Pilot
AdvaMed supports FDA’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program. This pilot program, which grew from the Case for Quality, explores a quality maturity appraisal, along with metrics and resource optimization, to improve patient safety and outcomes. AdvaMed members are participants in and endorse this program.
The FDA and MDIC are building the National Evaluation System for health Technology (NEST) to more efficiently generate evidence for medical device evaluation and regulatory decision-making. Once implemented, NEST will generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices. The collaborative national evaluation system will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records, and medical billing claims.