How to Choose the Right FDA Regulatory Pathway for your Device

Global Medical Device Podcast · 26 Feb 2020 · 38m · Episode 135

What this episode covers

Mike Drues of Vascular Sciences joins host John Spear to explain that medical device companies have 7 major FDA regulatory pathways, including 510(k), PMA, De Novo, HDE, PDP, CDE, and EAP, rather than just the two commonly known options. Drues details how classification depends on both technology and labeling, allowing companies to 'wordsmith' claims to access different routes, such as using a Humanitarian Device Exemption (HDE) for narrow patient populations or a Custom Device Exemption (CDE) for personalized 3D-printed devices. The discussion highlights strategic combinations, such as using an Emergency Access Program (EAP) for early feasibility data before a full PMA, or pursuing anatomy-specific pathways for the same device. Drues also clarifies that programs like Breakthrough Devices Program (BDP) and Safer Technologies Program (STEP) are not standalone pathways but efficiency accelerators for standard submissions.

Most relevant to

early-stage companies

Topics

Certification & compliance

Mentioned

Companies: Vascular Sciences, Green Light Guru
Also: FDA, 510(k), PMA, De Novo, HDE, CDE, EAP, BDP, STEP

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How to Choose the Right FDA Regulatory Pathway for your Device

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

077 - 8 Databases and How To Use Them with Michelle Lott

131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh