The US medical device bundling policy.
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.
Donawa
Maria
M
Donawa & Associates Ltd., Rome, Italy. medonawa@donawa.com
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004282:Documentation / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards; D017408:Guidelines as Topic; D011640:Public Policy; D014481:United States