Premarket notification
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The document outlines the steps for preparing a premarket notification submission or 510(k) for a medical device. The first step is to identify the product code, regulation number and review panel by searching the FDA classification database. The second step is identifying a predicate device that is already legally marketed and determining substantial equivalence by comparing the intended use, materials, and other characteristics. The third step is preparing the submission file which should refer to any special control guidance documents and take the format of an abbreviated or traditional 510(k) depending on guidance availability.
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UDI: What & How within the overall Medical Device value chain
Premarket notification
- 1. Premarket notification submission - steps to be followed Premarket notification submission or 510(k) submission is required when a manufacturer wants to market a class I, II or III device indented for human use, for which a Premarket approval (PMA) is not required but a premarket notification is required and the device is not exempted from 510(k) requirements. www.i3cglobal.com
- 2. Product code and Regulation number Each device is identified by unique product code, regulation number and review panel. Finding out the product code, classification and regulation number is the first step. This can be identified by typing the device name in the classification database of FDA http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/clas sification.cfm . We can also identify the special control guidance documents established by FDA. www.i3cglobal.com
- 3. Identification of predicate device Second step in a 510(k) submission is the identification of Predicate device. Premarket notification submission is the demonstration of the substantial equivalence of the device to be marketed to a device that is already legally marketed in the United states and which is not subject to PMA. Here the legally marketed device is the predicate device. Predicate device can be identified from database of FDA in which 510(k) summary of already cleared devices are available. Predicate device are determined considering Intended use, indications of use, materials, design, energy sources and other technological characteristics like software, hardware features, density, porosity, degradation characteristics, standards met, Biocompatibility, sterility and performance etc. www.i3cglobal.com
- 4. Submission file preparation Once the Predicate devices are confirmed, submission file preparation can be started. If any special control guidance documents established by FDA is available for the device, submission file should be prepared referring this guidance and the submission file will be an abbreviated 510(k). If no such guidance available a traditional 510 format should be followed and it will be called as traditional 510(k) submission. www.i3cglobal.com