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. 2016 Summer;2016(Spec Features):http://www.healthfinancejournal.com/~junland/index.php/johcf/article/view/82/83.

Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices

Neil J Wimmer  1 , Susan Robbins  2 , Henry Ssemaganda  2 , Erin Yang  2 , Sharon-Lise Normand  3 , Michael E Matheny  4 , Naomi Herz  5 , Josh Rising  5 , Frederic S Resnic  6
Affiliations

Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices

Neil J Wimmer et al. J Health Care Finance. 2016 Summer.

Abstract

Approved medical devices frequently undergo FDA mandated post-approval studies (PAS). However, there is uncertainty as to the value of PAS in assessing the safety of medical devices and the cost of these studies to the healthcare system is unknown. Since PAS costs are funded through device manufacturers who do not share the costs with regulators, we sought to estimate the total PAS costs through interviews with a panel of experts in medical device clinical trial design in order to design a general cost model for PAS which was then applied to the FDA PAS. A total of 277 PAS were initiated between 3/1/05 through 6/30/13 and demonstrated a median cost of $2.16 million per study and an overall cost of $1.22 billion over the 8.25 years of study. While these costs are funded through manufacturers, the ultimate cost is borne by the healthcare system through the medical device costs. Given concerns regarding the informational value of PAS, the resources used to support mandated PAS may be better allocated to other approaches to assure safety.

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Figures

Figure 1
Figure 1
Correlation of initial cost estimation model to median expert participant estimates
Figure 2
Figure 2
Median study costs ($) by organ system.
See this image and copyright information in PMC

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