Speed to market represents an important competitive advantage for medical device manufacturers, and can be a key factor in the total lifetime profitability of a new medical device.
This UL white paper discusses the challenges encountered by medical device manufacturers seeking market clearance under the FDA’s 510(k) program. The paper begins with an overview of the FDA’s various programs for the review of new or significantly modified medical devices, and a description of the information requirements for a 510(k) submission.
Author: UL LLC
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