In Brief: FDA shedding triage tiers
This article was originally published in The Gray Sheet
FDA shedding triage tiers: FDA's device center is preparing a "blue book" memo to reviewers notifying them that the 510(k) triage program is being discontinued. FDA is terminating the program, which linked stringency of review to device risk, because most Tier I (lowest risk) devices will no longer be subject to 510(k) review after Feb. 19, when most Class I products become exempt...
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