Future 510(k) NSE Letters May Indicate If Alternative Classification Feasible
This article was originally published in The Gray Sheet
Executive Summary
FDA may indicate in future "not substantially equivalent" 510(k) letters whether or not the sponsor's device is a likely candidate for placement in Class I or Class II using the new alternative low-risk de novo device classification process established by Sec. 207 of the FDA Modernization Act.
You may also be interested in...
VGI Trugene HIV-1 Test Downclassification Petition Anticipated By August
Visible Genetics, Inc. plans to submit a petition to FDA by August seeking classification of its Trugene HIV-1 genotyping test and OpenGene DNA sequencing system as Class II following FDA's rejection of a September 2000 510(k) submission.
VGI Trugene HIV-1 Test Downclassification Petition Anticipated By August
Visible Genetics, Inc. plans to submit a petition to FDA by August seeking classification of its Trugene HIV-1 genotyping test and OpenGene DNA sequencing system as Class II following FDA's rejection of a September 2000 510(k) submission.
FDA Denies Majority Of Requests To Reclassify Low-Risk De Novo Devices
Close to 63% of requests to FDA seeking Class I or Class II status for de novo devices without a predicate have been denied to date, FDA staffers say.