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Silicone Sheeting Becomes Class I Exempt Effective Sept. 8 – FDA Final Rule

This article was originally published in The Gray Sheet

Executive Summary

Class I exempt status for silicone sheeting applies to use of the product on intact skin, FDA emphasizes in an 1Aug. 9 final rule

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Regulatory News In Brief

Endotoxin activity assay gets Class II designation: Toronto-based Spectral Diagnostics petition requesting its endotoxin activity assay (EAA) be Class II is granted by FDA. A Federal Register notice will be published shortly, announcing the classification order. The generic device type is identified as "an endotoxin assay...that uses serological techniques in whole blood" and is "intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically-ill patients for progression to severe sepsis." Spectral submitted the de novo petition in April, after CDRH Director David Feigal indicated by letter that he believed the device would qualify for it, provided the firm included "careful and cautionary labeling," the petition notes. In October 2001, FDA's Microbiology Devices Panel voted against approving the EAA PMA, citing concerns about the test's sensitivity and how results would affect clinical therapy decisions (1"The Gray Sheet" Oct. 15, 2001, p. 7)...

Hemostatic Agent Downclassification Should Await Guidance – Panel

FDA plans to develop a draft guidance document for absorbable hemostatic agent 510(k) submissions and submit it for panel review before reconsidering downclassification of the devices

Ratio Therapeutics On BMS Investment, Radiopharma R&D Trends, AI Use

The CEO and CSO of radiopharmaceutical company Ratio Therapeutics, which now has Bristol Myers Squibb as an investor, talk about Ratio’s R&D platforms, use of AI, an independent FAP-targeted asset and trends in radiopharma research such as combining other modalities like ADCs, in this podcast interview with Scrip

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