Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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