Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis

Author:

Iijima Kazuo,Umezu Mitsuo,Iwasaki Kiyotaka

Funder

Initiative for Accelerating Regulatory Science in Innovative Drug, Medical Device, and Regenerative Medicine from Ministry of Health, Labour, and Welfare, Japan.

Publisher

Public Library of Science (PLoS)

Subject

Multidisciplinary

Reference28 articles.

1. Medical device regulation and its comparison in Europe, Australia and India;PB Patel;Indo American Journal of Pharm Research,2015

2. Balancing premarket and postmarket data collection for devices subject to premarket approval;CDRH Report,2015

3. Premarket clinical evaluation of novel cardiovascular device;DB Kramer;Am J Ther,2012

4. Postmarketing Surveillance of Medical Device–Filling in the Gaps;FS Resnic;Engl J Med,2012

5. How Dose Medical Device Regulation Perform in the United States and the European Union? A Systematic Review;DB Kramer;PLoS Medicine,2012

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