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Regulatory approval of new medical devices: cross sectional study

BMJ 2016; 353 doi: (Published 20 May 2016) Cite this as: BMJ 2016;353:i2587

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More PMA, less 510(k) clearance pathway might be better in terms of efficacy and safety. Re: Regulatory approval of new medical devices: cross sectional study

We read the cross sectional study by Marcus and colleagues [1] with interest. The study provides novel line of evidence pertaining to regulatory impact on new medical devices.
Indeed, innovative inventions greatly accelerate the development of new medical devices, by professional engineers and medical professionals with insights. Bearing facilitating the diagnosis and treatment for patients in mind, clinical investigators are at the forefront of such innovative inventions. They could unravel the underlying problems of current medical devices and consequently communicate with engineers from manufactures, aiming for enhancing the quality of devices. However, Marcus et al found that the majority of new medical devices were developed by industry alone (64%). As spinal surgeons and principal investigator funded by National Natural Science Foundation of China, we have a dozen of new spinal instrument patents issued. The ultimate goal of invents is to bring benefits for lessening the suffering of patients.
On the other hand, amongst the 218 medical devices in clinical studies, 45% received regulatory clearance of approval. In general, there are 2 types of regulatory clearance, i.e., 510(k) clearance pathway and more stringent Premarket Approval (PMA) pathway requiring clinical trials. In parallel with the study, Day et al [2] noted a similar tread that the most common clearance of medical devices is 510(k). However, Day et al reported that 510(k)-cleared devices were 11.5 times more likely to be recalled than PMA-pathway clearance devices. Given that most “new” medical devices are cleared via 510(k) pathway with limited clinical trial data, the scenarios of medical devices might not be optimistic. After all, random controlled clinical trials provide level I evidence to support a new medical device or product. Therefore, the scientific community should attach great importance to the issue. Furthermore, clinical professions should consider how the new device is approved by the FDA. A new device with 510(k) approval might indicate greater chance of being recalled.
1. Marcus HJ, Payne CJ, Hughes-Hallett A, et al. Regulatory approval of new medical devices: cross sectional study. Bmj 2016;353:i2587 doi: 10.1136/bmj.i2587[published Online First: Epub Date]|.
2. Day CS, Park DJ, Rozenshteyn FS, et al. Analysis of FDA-Approved Orthopaedic Devices and Their Recalls. The Journal of bone and joint surgery American volume 2016;98(6):517-24 doi: 10.2106/JBJS.15.00286[published Online First: Epub Date]|.

Competing interests: Supported by National Natural Science Foundation of China (No. 81270028 and 81572182).

26 May 2016
Hai-Qiang Wang
Spinal surgeon; Associate professor; Editor-in-Chief of Orthopedic Channel of DXY ; Principal Investigator of NSFC; Guest Editor of Curr Stem Cell Res T
Dr Ping-Heng Lan, Dr Jun Zhang (Baoji Municipal Central Hospital), Dr Fei Zhao
Department of Orthopaedics, Xijing Hospital, Fourth Military Medical University
127 Changle Western Road, Xi'an, China