Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medtronic pulls YouTube ad: In response to a Dec. 3 1citizen petition from consumer advocacy group the Prescription Project, Medtronic requested a video ad for its Prestige cervical disc, posted on YouTube and other Web sites by video production firm VNR-1 Communications, be removed from the Internet. The ad no longer appears on YouTube, Medtronic confirms in a Dec. 12 2letter to FDA, posted online Dec. 30. The Prescription Project said Medtronic, Stryker and Abbott advertised products online without legally mandated disclosures of potential risks and side effects (3"The Gray Sheet" Dec. 8, 2008, p. 7). Medtronic says it is reviewing the circumstances surrounding the posting by VNR, but does not plan to run any "curative ads," as they would "only add confusion to the matter.
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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
Incontinence Device Draft Guidance Suggests One-Year Randomized Studies
Randomized, controlled trials are the least burdensome means of collecting data to demonstrate safety and effectiveness of urinary incontinence devices, according to a Sept. 19 FDA 1draft guidance
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