WLF Briefing Critiques an FDA Gone Astray on Medical Device Regulation

This morning, Washington Legal Foundation is hosting a Media Briefing program at 9:30, FDA Goes Astray On Device Oversight: Proposed Guidance On 510(K) Review, Adverse Events Reporting, And Recalls.

Our speakers are:

• Gail H. Javitt, Sidley Austin LLP
• Philip J. Phillips, Phillips Consulting Group, LLC
• Richard A. Samp, Washington Legal Foundation

For those who cannot attend the program in person at WLF’s headquarters, below are the materials constituting press packet:

• Comments on 510(k) Citizen Petition
• Comments on In re Medical Device Reporting Guidance
• Comments on In re FDA Device Recall Reporting Requirements
• Press Release for amicus brief in U.S. Supreme Court case Medtronic v. Stengel
• Legal Backgrounder by Gail Javitt, FDA’s Device Recall Guidance: Significant Enhancement Required
• Legal Opinion Letter, Court Rejects Effort To “Preemption-Proof” Medical Device Lawsuit
• Legal Backgrounder, Missing The Point (Of Care): FDA Misreading Of CLIA Waiver Law Undermines Cost-Effective Health Testing