2026-10-07T04:07:28Z https://api.figshare.com/v2/oai

oai:figshare.com:article/33684949 2026-09-13T07:44:41Z category_25972 item_type_3 month_year_09_2026

Reproduction package: The welfare cost of reporting a median. Evidence from medical device certification Andreas Peters (24843127) Health economics clearants time effective patent term notified bodies Medical Devices Regulation small and medium-sized enterprises <p dir="ltr">Data and code behind every computed quantity in the article "The welfare cost of</p><p dir="ltr">reporting a median: Evidence from medical device certification".</p><p><br></p><p dir="ltr">The archive contains a single Python script and fifteen CSV files: FDA file-level</p><p dir="ltr">extracts for the 510(k), De Novo and premarket approval pathways; the receipt-cohort</p><p dir="ltr">records with the reconstructed applicant crosswalk; the parsed Federal Register</p><p dir="ltr">notices determining regulatory review periods; the patent term extensions granted</p><p dir="ltr">under 35 U.S.C. 156; the notified-body survey series commissioned by the European</p><p dir="ltr">Commission; the duration bracket definitions; Eurostat size-class figures; and a</p><p dir="ltr">table of every externally sourced parameter with its source and page.</p><p><br></p><p dir="ltr">Running the script reproduces the clearance-time distributions for the three US</p><p dir="ltr">pathways and for the European survey, the distribution-free identification bounds on</p><p dir="ltr">tail measures, the mixture-variance decomposition by firm size, the applicant-</p><p dir="ltr">experience regressions at the mean and at four quantiles, and the welfare arithmetic</p><p dir="ltr">of the article, including the cost of the reporting constraint across thresholds and</p><p dir="ltr">the share of the upper tail held by small and medium-sized manufacturers. It also</p><p dir="ltr">verifies the identity behind the welfare result against the empirical distributions.</p><p><br></p><p dir="ltr">Both the archive and its contents carry SHA-256 manifests, so a reader can establish</p><p dir="ltr">before and after extraction that the copy being run is the one the reported</p><p dir="ltr">quantities come from. All inputs are public. The applicant key used in the receipt-</p><p dir="ltr">cohort estimates is a reconstruction from the public applicant strings and not an FDA</p><p dir="ltr">field; it reproduces the identifier, the prior count and the submission order of all</p><p dir="ltr">15,702 analysis cases, but carries no claim about corporate control or renaming.</p> 2026-09-13T07:44:41Z Dataset Dataset 10.6084/m9.figshare.33684949.v1 https://figshare.com/articles/dataset/Reproduction_package_The_welfare_cost_of_reporting_a_median_Evidence_from_medical_device_certification/33684949 CC BY 4.0