Is the FDA Too Tough on Medical Device Makers?
Episode Description
Are the FDA's medical device regulations too hard, too soft, or just right? Wharton research indicates that the agency is on the right track. More: http://knlg.net/1Cb8KUR 📂 Health Care Management;Public Policy 🏷️ Research
Brief Summary
The episode discusses FDA medical device regulation, comparing it to EU standards and suggesting improvements in post-market surveillance for better consumer welfare.
Key points
- FDA's Regulatory Process. Examining the FDA's approach to medical device regulation and its effectiveness.
- US vs EU Device Regulation. Comparing the rigorous US standards to the EU's less stringent requirements.
- Improving Post-Market Surveillance. Research suggests enhancing post-market processes could benefit consumer welfare.
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Episode highlights
- US vs EU Device RegulationComparing the rigorous US standards to the EU's less stringent requirements.“The US FDA regulatory process was pretty close to optimal.”1:51Jun 25, 2015
- Improving Post-Market SurveillanceResearch suggests enhancing post-market processes could benefit consumer welfare.“There's a lot to be gained from increasing post market surveillance.”3:30Jun 25, 2015
