Originally Published MDDI October 2003REGULATORY OUTLOOKRobert Mosenkis President, CITECH

October 1, 2003

2 Min Read
How Fast is FDA Review?

Originally Published MDDI October 2003

REGULATORY OUTLOOK



Robert Mosenkis 
President, CITECH

For a given product category, it is quite easy to find, on-line, typical FDA 510(k) review times. It is necessary to know only the three-letter product code, which can be obtained from FDA on-line databases or from a predicate 510(k).
The entry point to this information is the search panel at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. (If typing such a long URL correctly is a challenge, access that search panel from the CDRH Home Page, www.fda.gov/cdrh, click on Databases—under Information Resources—then on Premarket Notifications.) In the search panel, enter the product code and press Search; you will get a list of all 510(k)s cleared under that code, in reverse chronological order of clearance date. Click on a number of these, one at a time, to display details about the most recent clearances. Don't bother looking at devices that you recognize as being very unlike yours (e.g., an accessory versus a complete system). Likewise, eliminate from consideration information on special 510(k)s or those that were reviewed by third parties (all of this information is shown on the details page for each device).

Record the date received and the decision date for about 10 recent submissions and estimate the time that each 510(k) file was open at FDA. Remember that this total time includes any periods where FDA was waiting for additional information that was requested of the sponsor, so it's a good idea to ignore times that seem much longer than most.

From the remaining data, it is possible to get a pretty good idea of how quickly FDA is reviewing 510(k)s for a given product category. Where that time is much longer than a couple of months, third-party review may be particularly appropriate. 

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