Hi Patricia,
I have no experience directly, but, the program sets time limits that would be attractive from a project management perspective. For instance, the third party (Accredited Person, in FDA lingo) reviews your product and sends their recommendation to the FDA. By law, the FDA must issue a final determination within thirty days. I would assume that third party labs would have a faster product evaluation cycle time than the FDA. Also, you have a definite milestone for your project schedule, rather than a question mark. The FDA seems to think it has benefits; from their website: http://www.fda.gov/cdrh/thirdparty/ During fiscal year 2002, 510(k)'s reviewed by Accredited Persons received FDA marketing clearance in an average of 77 days after initial receipt by the Accredited Person--29% faster than comparable 510(k)'s reviewed entirely by FDA. In addition, submissions reviewed by Accredited Persons are not subject to FDA user fees, while 510(k)'s sent directly to FDA are subject to a fee of $2,187 in fiscal year 2003. Most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements. Further, Accredited Persons have headquarters throughout the United States, in Europe, and in Taiwan, and have additional offices elsewhere, so they often can provide local service AP’s may also be used for factory inspections. Third party inspection program: http:// ww.fda.gov/cdrh/ap-inspection/ap-inspection.html. Good Luck! Doug Massey Product Safety Engineer Advanced Compliance Solutions Ph. (770) 831-8048 FAX (770) 831-8598 Visit our web home at http://www.acstestlab.com <http://www.acstestlab.com/> From: [email protected] [mailto:[email protected]] On Behalf Of Knudsen, Patricia J. Sent: Tuesday, November 11, 2003 5:03 PM To: [email protected] Subject: Third party review of 510K Does anyone have any experience with using a third party reviewer for FDA 510K submissions? I'm curious to see if the third party makes the process go any smoother. Patty Patricia Knudsen Sr. Certification Engineer Alaris Medical Systems Ph: (858) 458-7280 Fax: (858) 458-7095 [email protected]
