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Research

Regulatory approval of new medical devices: cross sectional study

BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2587 (Published 20 May 2016) Cite this as: BMJ 2016;353:i2587
  1. Hani J Marcus, clinical research fellow and specialty registrar1 2,
  2. Christopher J Payne, postdoctoral research fellow1,
  3. Archie Hughes-Hallett, clinical research fellow and, specialty registrar1,
  4. Adam P Marcus, foundation year trainee3,
  5. Guang-Zhong Yang, professor and codirector1,
  6. Ara Darzi, professor and codirector1,
  7. Dipankar Nandi, consultant neurosurgeon2
  1. 1The Hamlyn Centre, Institute of Global Health Innovation, Imperial College, London W2 1NY, UK
  2. 2Department of Neurosurgery, Imperial College Healthcare NHS Trust, London, UK
  3. 3Faculty of Medicine, Imperial College, London, UK
  1. Correspondence to: H J Marcus hani.marcus10{at}imperial.ac.uk
  • Accepted 1 May 2016

Abstract

Objective To investigate the regulatory approval of new medical devices.

Design Cross sectional study of new medical devices reported in the biomedical literature.

Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.

Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.”

Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.

Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.

Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study.

Footnotes

  • Contributors: HJM and CJP had equal contribution and act as guarantors. They conceived the study, acquired and analysed the data, and drafted the manuscript. AH-H and APM conceived the study, acquired and analysed the data, and critically revised the manuscript. DN, G-ZY, and AD conceived the study and critically revised the manuscript.

  • Funding: HJM was supported by an Imperial College Wellcome Trust clinical fellowship, and CJP was supported by a Wates Foundation fellowship.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: Not required.

  • Data sharing: No additional data available.

  • Transparency: The lead authors (the manuscript’s guarantors) affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

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