Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Device evidence develops across the product lifecycle, including after the initial approval decision.
What the paper explores
The investigators mapped clinical studies associated with high-risk therapeutic devices receiving initial FDA premarket approval in 2010 and 2011. They examined study timing, designs, comparators and completion status, finding substantial variation in the evidence generated before and after market entry.
How to interpret the evidence
This is a historical cohort assessed at a particular follow-up date. It should not be presented as a current measure of all device studies or present-day regulatory practice.
Questions for MedTech teams
Build a lifecycle evidence plan that distinguishes the question answered at initial submission from the questions requiring longer follow-up or post-market investigation.
Sources & further reading
Read original paperDOI: 10.1001/jama.2015.8761
Bibliographic record and abstract on PubMedThis is a short editorial reading note on external research. The original research is attributed to its authors and does not represent an HMC study, product validation or regulatory determination.
