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Review
. 2017 Jul-Aug;114(4):283-288.

FDA Device Regulation

Madelyn Lauer  1 , Jordan P Barker  2 , Mitchell Solano  3 , Jonathan Dubin  4
Affiliations
Review

FDA Device Regulation

Madelyn Lauer et al. Mo Med. 2017 Jul-Aug.
No abstract available

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Figures

Figures 1a/1b/1c
Figures 1a/1b/1c
Number of orthopaedic devices advanced to market between 2000–2016 1a. Humanitarian device exemptions Data acquired from the Humanitarian Device Exemption Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm. Advisory Committee: Orthopedic. Accessed February 27, 2017. Each device was counted only once. 1b. 510(k) clearances Data acquired from the 510(k) Premarket Notification Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Panel: Orthopedic. Accessed February 27, 2017. 1c. Premarket approvals Data acquired from the Premarket Approval Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Advisory Committee: Orthopedic. Supplement Type: Originals Only. Accessed February 27, 2017.
Figures 1a/1b/1c
Figures 1a/1b/1c
Number of orthopaedic devices advanced to market between 2000–2016 1a. Humanitarian device exemptions Data acquired from the Humanitarian Device Exemption Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm. Advisory Committee: Orthopedic. Accessed February 27, 2017. Each device was counted only once. 1b. 510(k) clearances Data acquired from the 510(k) Premarket Notification Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Panel: Orthopedic. Accessed February 27, 2017. 1c. Premarket approvals Data acquired from the Premarket Approval Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Advisory Committee: Orthopedic. Supplement Type: Originals Only. Accessed February 27, 2017.
Figures 1a/1b/1c
Figures 1a/1b/1c
Number of orthopaedic devices advanced to market between 2000–2016 1a. Humanitarian device exemptions Data acquired from the Humanitarian Device Exemption Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm. Advisory Committee: Orthopedic. Accessed February 27, 2017. Each device was counted only once. 1b. 510(k) clearances Data acquired from the 510(k) Premarket Notification Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Panel: Orthopedic. Accessed February 27, 2017. 1c. Premarket approvals Data acquired from the Premarket Approval Database found at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Advisory Committee: Orthopedic. Supplement Type: Originals Only. Accessed February 27, 2017.
Figure 2
Figure 2
Common FDA pathways to market
None
See this image and copyright information in PMC

References

    1. Makower J, Meer A, Denend L. FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. November 2010. 2010 http://advamed.org/res.download/30. Accessed May 28, 2016.
    1. U.S. Food and Drug Administration Overview of Device Regulation. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/d... Accessed March 4, 2017.
    1. Public Citizen. Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened. https://www.citizen.org/documents/substantially-unsafe-medical-device-re....
    1. Monsein LH. Primer on medical device regulation. Part III. Regulatory mechanisms and import/export regulation. Radiology. 1997;205(1):19–25. - PubMed
    1. Barker JP, Dubin J. Recent Trends in Orthopedic Device Regulation. Orthopedics. 2015;38(7):410–412. - PubMed

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