MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in...
Total Product Life Cycle : Product Launch Phase
Once a device has received marketing authorization from the FDA, there are additional steps the sponsor must take in preparing to make the device available for public use. This includes finalizing the “device master record” (DMR), which includes all the records relating to the procedures and specifications for a finished device. It is often recommended that a sponsor work on finalizing the DMR in parallel with the development cycle to make the process of bringing the device to market once authorized as seamless as possible.
Additional steps the sponsor must take during the product launch phase include setting up a network for distributing the product to providers and the public, developing marketing materials, and registering with the FDA.
Read about the Total Product Life Cycle here »
A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...