FDA Announces Sentinel Program; Stakeholders Watch For Details
This article was originally published in The Gray Sheet
Executive Summary
The Department of Health and Human Services unveiled the first phase of FDA's Sentinel post-market safety surveillance initiative with fanfare May 22, but stakeholders will have to wait for details on funding and the timing of a full-scale rollout
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FDA Sentinel Initiative Needs Safeguards To Protect Industry And Patients
A greatly expanded drug and device surveillance program could do more harm than good without proper safeguards in place, according to participants at a Dec. 16 FDA-sponsored workshop
FDA Sentinel Initiative Needs Safeguards To Protect Industry And Patients
A greatly expanded drug and device surveillance program could do more harm than good without proper safeguards in place, according to participants at a Dec. 16 FDA-sponsored workshop
Regulatory News In Brief
Can OTC tests be 510(k) exempt?: A Dec. 1 citizen petition seeks FDA clarification on whether Class I in vitro diagnostics sold over the counter are eligible for 510(k) exemption. On behalf of an unnamed client, Hyman, Phelps & McNamara attorney Jeffrey K. Shapiro asks the agency for a formal advisory on a regulation that excludes "near patient testing (point of care)" Class I tests from pre-market notification exemptions. "We believe that this 'near patient' or 'point of care' category applies to testing performed outside a laboratory environment by a health care professional [and] does not include over-the-counter tests intended for lay users," he writes. FDA actions have been "inconsistent" on the issue, according to Shapiro