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Third Party Review of FDA 510(k)
On August 1st, 1996 FDA launched a pilot program
allowing voluntary Third Party Review of selected devices. The program allowed
the FDA to concentrate on higher risk devices, while approved Third Party
Reviewers handled low to medium risk products. A list of approved reviewers was
published by the FDA on September 23, 1998. One month later the pilot program
was cancelled; the Agency began accepting reviews by Accredited Persons.
List of eligible devices can be found on the FDA's website at the following
location:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm#4
The products the Agency excludes from third party review includes devices that
require multi-Center review such as drug/device combination products or devices
that fall under the Center for Biologics Evaluation and Research. The program
also excludes devices that are permanent implants,
life-supporting/life-sustaining, or which require clinical data.
Benefit of using Accredited Persons for review
There are a number of reasons why you would want to use a Third Party to review
your 510(k)s - the obvious reason is time. Third Party reviewers can expedite a
review and substantially cut down the amount of time that would be required had
you gone through the Agency. Ironically the fees that an Accredited Person may
ask may be surprisingly less than you would think. The reason is that the Agency
waives their fees for third party reviews - which ranges from $3,066 to $3,833.
Waiving the cost of the review allows the Accredited Person to charge you at or
slightly above the Agency costs, in return you have an expedited review of your
application.
Other benefits include having the luxury of calling your reviewer and getting
immediate (or very quick) feedback on the progress of the submission. It is no
secret that the Agency is burdened with enormous workloads. Often the same agent
responsible for reviewing your submission may also be responsible for processing
industry inquiries. This multi-tasking can make returning calls and inquiries
slow.
What happens after Third Party Reviews?
When the Third Party Reviewer finishes the review of your submission and given
that everything was satisfactory, the next step is for the Agency to “process”
the submission. There have been varying reports indicating how long this usually
takes. Estimates have the turn time anywhere from 48 hours to 2 weeks. You
should always budget at least 2 additional weeks (in addition to the Third Party
Review estimate).
What to Look For when Shopping for a Third Party Reviewer?
A good Third Party Review should have experience. Over years these organizations
develop contacts and effectively trust with the Agency. This can help cut the
processing time down further.
The other factor to consider is cost. In some cases you may be paying more than
what the FDA charges. Usually this cost is justified – especially when
considering total turn time.
Conclusion
In conclusion a
Third Party Reviewer can in most cases help process applicable 510(k)
submissions in considerably less time than the FDA. In circumstances where turn
time processing is a concern the additional costs can sometimes be justified.
However, if time isn’t important then having your 510(k) processed through the
Agency may be your best bet.
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