Hardware Podcasts

Overcoming Submission Deficiencies due to Biocompatibility

Global Medical Device Podcast · 1 Sept 2022 · 29m · Episode 278

What this episode covers

Chris Parker, Associate Department Head of In-Vivo Biocompatibility at LabCorp (formerly Toxikon), explains how medical device manufacturers can avoid and resolve FDA submission deficiencies related to biocompatibility. He details the two primary paths for addressing deficiencies—risk assessment/memo or retesting—and emphasizes the importance of proactive engagement with regulatory bodies and toxicologists during the early prototyping phase. The discussion covers material screening for Prop 65 and European CMR regulations, the challenges of testing small-surface-area devices like stents, and the financial impact of remedial work on company timelines.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
LabCorp, Toxikon, Green Light Guru
Also
FDA, ISO 10993, Prop 65, MD&M West

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