Overview of the US FDA Medical Device Approval Process
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Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.
KeywordsFDA Medical device Approval Regulatory PMA IDE 510(k) HDE CDRH MAUDE Safety monitoring Pivotal study
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Conflict of Interest
Ashwani Sastry declares that he has no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance
- 1.FDA's Medical Device Program 2013: Looking Back and Looking Ahead. Available at http://xavierhealth.org/wp-content/uploads/7.-Shuren_FDA-Update.pdf.
- 3.•FDA Guidance Document: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM279103.pdf. This Guidance document represents a signficiant step toward bringing early feasibility studies back into the United States.
- 4.Medical Device Innovation Initiative White Paper: CDRH Innvovation Initiative. Available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm242067.htm.
- 7.Draft Guidance Document: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications. Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM198043.pdf.