Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we have different impressions on that topic, so we decided to inform the debate with a systematic look at the data. While we can both claim some evidence in support of our respective theses based on the analysis, Brad must admit that Colleen’s thesis that MDRs tend to lag recalls has the stronger evidence. We are no longer friends. At the same time, the actual data didn’t really fit either of our predictions well, so we decided to invite James onto the team to help us figure out what was really going on. He has the unfair advantage of not having made any prior predictions, so he doesn’t have any position he needs to defend.
Recent Updates
- CMS Receives Its Exclusion Authority: What Happens Now?
- GLOBE Model Final Rule Drops — but Will It Work on a Smaller Scale?
- Congressional Action on Health Care Cybersecurity: HISAA Is Re-Introduced and the Health Care Cybersecurity and Resiliency Act Moves Forward
- DOJ Corporate Fraud Enforcement Memo: What Health Care Companies Need to Know Now
- Attorneys General of Three States File Two Sweeping Lawsuits Targeting Telehealth Abortion Providers and State Shield Laws