Additional references

1 Center for Devices and Radiological Health (CDRH). 2015. Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling: DRAFT GUIDANCE for Industry, Food and Drug Administration Staff, and Other Stakeholders. Available from: Last access on 03 June 2015.

2 Medical Device Innovation Consortium (MDIC) Patient centered benefit-risk project report. 2015. A framework for incorporating information on patient preferences regarding benefit and risk into rgulatory assessments of new medical technology. Available from: Last access on 03 June 2015.

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