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The US medical device bundling policy
1Donawa & Associates Ltd., Rome, Italy. medonawa@donawa.com
Medical Device Technology
|October 20, 2005
Summary
United States (US) premarket submissions can be streamlined by bundling multiple devices or indications into a single filing. This policy, detailed in a US guidance document, offers potential time and cost savings for companies.
Area of Science:
- Regulatory Affairs
- Medical Device Compliance
Background:
- Companies preparing US premarket submissions face regulatory hurdles.
- Efficient submission strategies are crucial for time and cost management.
Purpose of the Study:
- To inform companies about a US policy enabling the bundling of devices or indications.
- To explain the appropriate use of this bundling policy.
Main Methods:
- Discussion of the US premarket submission policy.
- Analysis of a relevant US guidance document.
Main Results:
- A policy exists allowing the bundling of multiple devices or indications in one submission.
- Guidance is available on the appropriate application of this policy.
Conclusions:
- Companies can leverage the bundling policy to potentially reduce submission time and costs.
- Understanding the guidance document is key to successful bundling.