Author Contributions: Mr Rome and Dr Kesselheim had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Acquisition of data: Rome.
Analysis and interpretation of data: Rome, Kramer, Kesselheim.
Drafting of the manuscript: Rome.
Critical revision of the manuscript for important intellectual content: Rome, Kramer, Kesselheim.
Statistical analysis: Rome.
Obtained funding: Rome, Kesselheim.
Administrative, technical, and material support: Kramer, Kesselheim.
Study supervision: Kramer, Kesselheim.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kramer reported serving as a consultant to the FDA’s Circulatory Systems Advisory Panel. Drs Kramer and Kesselheim reported previously publishing research funded by the FDA on comparative medical device regulation. No other disclosures were reported.
Funding/Support: Mr Rome was supported by a Harvard Medical School fellowship. Dr Kramer is the Lois Green Scholar at the Hebrew SeniorLife Institute for Aging Research and is supported by a career development award from the Harvard Catalyst Clinical and Translational Research Center and a Paul B. Beeson career development award in aging (1K23AG045963). Dr Kesselheim is supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research, a Greenwall Faculty Scholarship in Bioethics, and a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01).
Role of the Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.