FDA does not provide approval or certification through 510 k process nor issue a certificate of registration, but you will get a 510 k number.
FDA 510(k) is not FDA approval or FDA certification of the medical device, it is only a marketing clearance. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. Once the device is determined to be SE, it can then be marketed in the U.S. Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."įDA 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Data and information relating to safety and effectiveness of a device classified in class III (premarket approval) that have not been released to the public shall be retained as confidential unless such data and information become available for release to the public under § 860.5(d) or other provisions of this chapter.FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). Upon final classification, data and information relating to safety and effectiveness of a device classified in class I (general controls) or class II (performance standards) shall be available for public disclosure. (e ) Data or information submitted with, or incorporated by reference in, a premarket notification submission (other than safety and effectiveness data that have not been disclosed to the public) shall be available for disclosure by the Food and Drug Administration when the intent to market the device is no longer confidential in accordance with this section, unless exempt from public disclosure in accordance with part 20 of this chapter. (Information collection requirements in this section were approved by the Office of Management and Budget (OMB) and assigned OMB control number 0910-0281)
If the additional information is not submitted within 30 days following the date of the request, the Commissioner will consider the premarket notification to be withdrawn. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Commissioner to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least 90 days before the owner or operator intends to market the device, or submit a premarket approval application in accordance with section 515 of the act. (m ) Any additional information regarding the device requested by the Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution.
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