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American Economic Review Vol. 110 No. 1 2020

Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices

Matthew Grennan1; Robert J. Town2

1 The Wharton School, University of Pennsylvania, and NBER (email: ) · 2 University of Texas-Austin, and NBER (email: )

open access

Abstract

We study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare. Product testing can reduce consumer uncertainty, but also increase entry costs and delay entry. Using variation between EU and US medical device regulations, we document patterns consistent with valuable learning from more stringent US requirements. To derive welfare implications, we pair the data with a model of supply, demand, and testing regulation. US policy is indistinguishable from the policy that maximizes total surplus in our estimated model, while the European Union could benefit from more testing. “Post-market surveillance” could further increase surplus.

DOI
10.1257/aer.20180946
Volume
110
Issue
1
Pages
120-161
Language
en
Sources
bibtex:phds-export.bib openalex crossref

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