Presentation archive: November 2020
Chris Thierfelder of PMO Partners presented a webinar hosted by the San Francisco Bay Area RAPS chapter on November 6, 2020. The discussion addressed the FDA’s thinking at that time about Class II device review, including 510(k) and De Novo pathways.
Connect strategy with development
The announced topics included submission planning, evaluating potential clinical testing needs, and using risk analysis to inform product development plans. The enduring principle is to account for the regulatory pathway early enough that evidence requirements can shape execution.
This is a historical presentation overview. It does not reproduce the original recording or provide current pathway requirements, which should be confirmed against contemporary agency guidance for the specific device.