Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

the following describes a typical 510(K)...

The 510(K) for a Class II device is submitted typically as a loose leaf note book consisting of several volumes. A typical submission may consist of three 250 pages per volumes and approximately 750 pages. An original and a copy must be submitted. The original must contain specific pages bearing an official signature of the person responsible to the FDA.

Any imprecise statement can cause a question from the FDA. Each page must be crafted to clearly move your device closer to a determination of substantial equivalence to a legally marketed device.

Any one page may require over a day to write. Often the subject is tedious and must be precisely calculated to present the product in the best possible light to the FDA.

When filed, the FDA has 90 days in which to respond. Typically they respond with a list of 9-14 questions. If the submission is complete, the FDA will notify you that they have received it. They have the option to reject the submission it the submission is NOT complete.

We have created a through, diligent, complete submission. Typically each project has weak areas. We find them and correct them. This task focuses on the product application and includes:

Classification Name/Common/Proprietary names, Device Classification,

Performance Standards applicable,

Indications for Use,

Comparison to predicate device,

Equipment Covered,

Labeling & User Information,

Marketing Claims,

Promotional Material,

Labeling Information,

Substantial Equivalence,

Specifications,

Mechanical Drawings,

Product Documentation,

Software Quality Assurance Program,

Test Procedures,

Accessories,

Safety Features,

Calibration,

Summary of Safety & Effectiveness, &

Product Development to Design Controls,

Safety Testing,

Product Testing.,

We use the threshold philosophy: we make it hard for the FDA to question and easy to for them to approve the submission. There is a threshold of quality and completeness that we must reach in the submission to achieve this likelihood. Please consider, we cannot misrepresent the project. If you were weak in program testing, safety testing, risk analysis we can repair those areas.

We build an application to present your device in the best possible light. We create an application to obscure your program weakness.

copyright by Compliance Consultants, Stamford, CT USA, September 2001