In Reply The letter by Phillips reflects his perspectives as a former US Food and Drug Administration (FDA) regulatory official and current consultant to device companies: he expresses more concern about overtaxing FDA resources than about the lack of information available to health professionals. As public health researchers, our perspective is different: We believe that public access to scientific evidence about medical implants would improve medical outcomes.
Zuckerman DM, Brown P. Sufficiency of Information in 510(k) Summaries—Reply. JAMA Intern Med. 2015;175(5):864. doi:10.1001/jamainternmed.2015.84