Medical Device Submissions Guidebook: 510(k) & De Novo
This in-depth 510(k) & De Novo Guidebook will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Resource Library
Access our full library of guidance, white papers, and other resources developed by and for the medical technology industry.
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State of the Nation 2025: Global Medical Device Recall Index Report
Download Sedgwick’s Global Medical Device Recall Report for key insights on compliance, regulations, and global recall trends. Members only.
The Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Connected Medical Devices
This white paper, “Connected Medical Devices”, explores the transformative impact of integrating Bluetooth Low Energy (BLE), mobile apps, cloud platforms, and AI/ML into medical devices. It highlights the benefits of…
MedTech Reimbursement Playbook
Learn the basic principles of how medical technologies are covered and paid by insurers and the challenges medtech companies face.
Listen to AdvaMed®'s Podcast
Brought to you by AdvaMed®, Medtech POV with Scott Whitaker is a podcast that covers the intersection of medtech and policy from every perspective.
Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
PFAS in Medtech
Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices…
Artificial Intelligence in Medtech
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Artificial Intelligence in Medical Technology Myths and Facts
Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.