510(k) vs. PMA Regulatory Strategies

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Approaching FDA w/Multiple Areas
Date: 7/28/2011
Length: 3 minutes
Speaker(s): Howard Holstein
Sources: Stanford Biodesign
Description: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 5: How would a company approach the FDA for products that span multiple clinical areas?

Other Videos in Series

Approaching FDA w/Multiple Areas
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 5: How would a company approach the FDA for products that span multiple clinical areas?
Watch More
Basics of 510(k) Clearance Process
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 1: What are the basics of the 510(k) clearance process?
Watch More
Basics of PMA Approval Process
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 3: Can you give us the basics of the PMA process?
Watch More
Care as Device Moves to Market
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 6: What does an innovator/company need to be careful about as the device moves to market?
Watch More
Concerns about 510(k) Clearance Process
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 2: Can you talk about recent concerns in the 510(k) process?
Watch More
Key Differences: 510(k) vs. PMA
Howard Holstein
7/28/2011
Summary: Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA Regulatory Strategies: Question 4: What are the key differences between the 510(k) and PMA pathways?
Watch More

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