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The US medical device bundling policy
1Donawa & Associates Ltd., Rome, Italy. medonawa@donawa.com
Abstract:
Companies preparing United States (US) premarket submissions should be aware of a US policy that may save them time and money. This policy allows the grouping or "bundling" of multiple devices or multiple indications for use in a single submission. This article discusses this policy and a US guidance document that explains when bundling is appropriate.
