Proposed Rule Is Next Step Toward eSubmissions Future At FDA
The US agency issued a proposed rule this week to remove requirements for multiple copies of pre-market submissions, requiring one electronic version instead.
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The US FDA has finalized a new rule that updates a slew of agency regulations so sponsors no longer have to submit multiple paper copies of premarket submission applications. The agency says the rule could save companies millions of dollars.
The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.