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Special 510(k)
User Fees

510(k) Support

The CRO Group is experienced preparing and filing 510(k)s or supporting your preparation and filing effort.

There are now three separate 510(k) filing methods.  If you have a quality system with design controls in place and the new device is either a line extension (same materials, same use indications, same operating principle, etc.) or conforms to a recognized standard (such as ISO, EN, UL, etc.) then we can use one of the two new filing methods.  The main advantage to the two new methods is FDA's review and clearance time:  30 days vs. 90 days.  To find out more, click here.  Finally, almost all 510(K)s require a user fee to be submitted PRIOR to the 510(K) in order for the review to start.  This can be a very costly blunder to get straightened out.  Click here for more information on user fee management.

All 510(k)s require performance and safety testing.  For electrical and electronic products, this means testing to the electromedical safety standard IEC EN 60601-1/UL2601, and EMC (electromagnetic compatibility) standards for emissions and immunity listed in   IEC EN 60601-1-2.  For more information on how you can have your equipment pass these tests, click here.

If the device is invasive or implanted, or makes contact with the skin, or is intended to be inserted into body orifices (such as an ear thermometer), it must be shown to comply with the biocompatibility standards listed in IEC 10993-1 / EN30993-1.  If the device is produced and packaged to be sterile, a sterilization and packaging validation are expected with the submission.  For the latest information on these standards, click here.

Finally, there are specific labelling requirements for both the over the counter/non-prescriptive and prescription only devices.  Specific cautions and warnings associated with the above mentioned standards as well as those related to the use of your device are expected in the file.

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