FDA Moves from Paper to Electronic Format for Device Premarket Submissions Beginning in January

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FDA Moves from Paper to Electronic Format for Device Premarket Submissions Beginning in January

Dennis Tosh

December 19, 2019 at 01:58 PM EST

The FDA has finalized a rule that eliminates the requirement for medical device sponsors to submit multiple paper copies of premarket submissions to the agency. Under the rule, released by the agency on Dec. 13, sponsors will be able to provide a single submission in electronic format instead. The FDA said that the final rule “will produce cost savings for firms without impos... Read More

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FDA Moves from Paper to Electronic Format for Device Premarket Submissions Beginning in January

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