Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. It is the FDA’s most stringent review process and is reserved for those medical devices where failure can result in death or serious, deleterious impacts to a patient’s health. In all cases, clinical evidence of safety and efficacy must be presented for FDA review. And, the device cannot be placed into commerce FDA completes a quality inspection of the manufacturer. FDA’s review of a PMA application can take from 6 months to years before market authorization is granted.
A year by year listing of FDA approved medical devices available at the following web address:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199026.htm
The PMA application will contain the extensive data necessary to ensure FDA that the device in question is safe when as used and that the risk to benefit ration is sufficiently high to justify marketing authorization. Included in the application will be the results of clinical trials of the medical device that have been pre-approved by FDA through the allowance of an Investigational Device Exemption (IDE).
Details on the PMA and the content of a PMA application can be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm and http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089535.pdf
An approved Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to the FDA. In some cases, IDEs are approved by an Institutional Review Board. If the study involves a significant risk device, the IDE must also be approved by FDA. A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. Guidance on distinguishing between significant risk and non-significant risks studies are outlined in the document available at: http://www.fda.gov/oc/ohrt/irbs/devrisk.pdf
The sponsor of the clinical trial is responsible for submitting the IDE application to FDA and obtaining IRB approval before the study can begin. Study approval must be obtained PRIOR to enrolling patients at the study site. Each site must have approval from the reviewing IRB for that site prior to beginning the study. Further information on IDEs is available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm
Research by Eliza Brannigan & Kristin Stiner
