FDA electronic premarket submissions program includes 30 filings to date.
This article was originally published in The Gray Sheet
Executive SummaryFDA ELECTRONIC PREMARKET SUBMISSIONS REVIEW: 30 FILINGS have been or are currently being evaluated by the agency. To date the majority of the electronic submissions have been premarket approval application supplements with a few 510(k)s. The agency has also received one investigational device exemption supplement, but no original IDEs or PMAs. The electronic applications have been submitted by a total of 12 device companies.
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