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Ravi Parikh, Anand Gopal, Christopher Teng, Lucian Del Priore, Joseph S. Ross; A Comparison of Regulatory Approval Time for Ophthalmic Devices in the United States and Japan. Invest. Ophthalmol. Vis. Sci. 2017;58(8):5076.
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© ARVO (1962-2015); The Authors (2016-present)
Medical device approval in the United States is regulated by the Food and Drug Administration (FDA), which is frequently criticized for its approval processes, including perceived slow regulatory reviews times and delayed approvals when compared with other developed nations. In Japan, medical device approvals are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA), using similar evidentiary processes and standards as FDA. We sought to compare the regulatory review time required for approval of ophthalmic medical devices between the United States and Japan.
We used the most recent publically available data for initial medical device approvals from PMDA and FDA (2007-2015) to identify ophthalmic devices approved in both countries. Devices were compared regardless of approval track in their respective nations. We compared days of regulatory review for each agency using Wilcoxon signed-rank tests and characterized country of first approval using descriptive statistics. Statistical analyses were performed using JMP Pro Version 11.2.0 (SAS Institute Inc.).
From 2007-2015, 29 ophthalmic devices were approved by both the FDA and PMDA; 34.5% (10/29) of these were contact lenses, 31.4% (9/29) were surgical lasers/devices (8 lasers and 1 microkeratome), 24.1% (7/29) were intraocular lenses (IOLs), and 10.3% (3/29) were glaucoma drainage devices. Overall, regulatory review times were similar across PMDA (median: 238 days; range: 52-650) and FDA (median: 192 days; range: 54-960) approvals (p=0.48). Likewise, regulatory review times did not differ significantly between agencies when stratified by device type: (contact lenses, p=0.56; IOLs, p= 0.30; surgical lasers/devices, p=0.10; glaucoma drainage devices, p=1.00). However, among these devices, the large majority (26/29; 89.7%) were first approved in the United States, whereas just 10.3% (3/29) were first approved in Japan.
While the FDA and PMDA had similar regulatory review times to approve ophthalmic devices, nearly 90% of all devices are approved first for use in the United States.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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