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