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Benefit's
of Third Party Review of Low to Medium Risk 510(k)s
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.
END