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        Products and Medical Procedures

Device Approvals, Denials and Clearances

                        
                


                Recently-Approved Devices
          510(k) Clearances
          PMA Approvals
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          Medical Devices
          Products and Medical Procedures
          Device Approvals, Denials and ClearancesProducts and Medical Procedures Device Approvals, Denials and Clearances
  	
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    PrintWelcome to FDA's information about medical device approvals. The following information is available:

Recently Approved Devices that include some of the newest medical technology available.
	Listings of Premarket Notification [510(k)] and Premarket Approval (PMA) decisions
	Information on Humanitarian Device Exemption (HDE) approvals
	Evaluation of Automatic Class III Designation (De Novo) Summaries
	Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.Databases

CDRH maintains searchable databases on its website containing 510(k) and PMA information

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

Search the 510(k) DatabasePremarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

Search the PMA DatabaseRegulation also provides for the submission of a humanitarian device exemption (HDE) application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 8,000 individuals in the United States per year. The (HDE) application is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.

Search the Humanitarian Device Exemption (HDE) databaseThe Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option, which is also known as Evaluation of Automatic Class III Designation. This option provides an alternate pathway to classify novel devices of low to moderate risk. Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.

Search the de novo DatabaseCDRH also has available a number of other databases relating to medical devices and radiation-emitting products. Information not contained in the CDRH databases must be requested via a Freedom of Information request.

                                                                                  Content current as of:
      11/06/2023Device Approvals, Denials and Clearances                
                          

                        


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