Welcome to Compliance Consultants...

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

What you do; what we do.

Project Sequence.

The following describes our task from start to finish during a project. Its purpose is to illustrate the typical time we spend for each activity. Once you retain us we research the regulatory issues. This research occurs from our interviewing you over the phone (8 hours) and researching FDA requirements (16 hours). This is a real search that includes many phone calls. This research is NOT just a WEB search. We ask you to send us all the available engineering documents you have prepared so we may review these (16 hours). We determine the applicable issues to your project and the regulatory requirements that must be covered in your 510(K). We develop a regulatory strategy or plan(8 hours). We develop an agenda in preparation to our Technical Exchange Meeting to visit you (8 hours). We visit you for approximately three days to understand your development project and acquire the necessary knowledge to create the FDA application (32 hours). In this first phase we spend 88 hours planning your FDA application.

After we return from this Technical Exchange Meeting, we analyze your engineering development plan and the various documents that support your plan and the product. We analyze your regulatory strategy and devise a list of the additional engineering documents that must be created to achieve what we call is a "first round approval" quality. It does not guarantee an approval. This term defines a "benchmark" for a submission that will "lack nothing" and would be viewed by the FDA as "complete". This application would include your Design Controls (such as a requirements specification, testing plans, etc.) and manufacturing, safety, risk analysis etc. Typically 30-40 documents are required for a modern, complex computer driven medical device. We are skilled in these technologies. To analyze, explain and develop a plan for these documents requires approximately 80 hours.

We shape your device to fit through the FDA regulatory process. This requires time on our part. We commit on the design. We are development engineers and your will discover we are qualified. We may advise your device must be divided into a disposable and durable product. We may advise you subtract the computer from the system and re-define it as a software only product. We may tell you that you should not use a DC servo but instead stepper motors for measurable feedback. We may advise that your input sensor such as a test strip must be upgraded to a biosensor. We may advise that you omitted a critical test to establish a fundamental scientific precept of your device and more testing must be accomplished. In almost every case, we will assist you in re-designing your testing program for the device. It usually only requires 8 hours for us to generate our comments and another 80 hours to work out the detail engineering changes with you.

Once the changes are established, these will impact your development plan and associated documents. Once these documents are prepared, we spend approximately another 80 hours reviewing and commenting on their content and format to ensure these documents support your revised engineering plan and the modified product.

All the above efforts usually occur within the first 60 days of the project. We work with you

With all the documents now prepared, we draft the application. This takes the FDA regulations and shows how your new medical device complies with the various regulations for claims, labeling, indications for use, substantially equivalence, design controls, safety controls, software controls, calibration, testing, field support, etc. We explain to the FDA how your engineering system will ensure the advertised product throughout its life cycle. We discuss EACH of your documents and explain how the document fits into your system. To write this application which typically is 100 pages requires a mere 80 hours (because we have done so many).

We submit the draft application to you for final approval and signature. We make any changes. This process requires about 16 hours. We make multiple copies, hand check each edition for perfection and submit the originals to the FDA. This process requires about 24 hours. We use senior people to ensure nothing can go wrong.

Once submitted, we receive confirmation within about 10 days that the application has been accepted and assigned a 510(K) number. We follow up and discover the review status each 30 days. This process requires about 8 hours.

After 90 days, the FDA must react to the application. We have observed over the last recent submissions for a new complex device, that the FDA will ask typically 15 questions calculated to discover if the principals are really capable.

For answering questions, you will value our energy and initiative. We immediately send you the FDA questions (24/7). Within days, we draft preliminary answers or state precautions, limits and boundaries for each question. Within days, we develop a strategy; We conduct a conference call and discuss each question. We develop personnel assignments to control each answer and who will respond. In the earlier exploratory sessions, this process requires about 24 hours.

We work with you to write the final answers AND develop or modify any documents required to clarify these answers. Typically 10 new documents must be submitted to address these questions. We work with you to ensure these documents are cover the issues raised. This document investigation process requires about 40 hours.

If necessary, we travel to Rockville, MD and visit with the FDA (Center for Devices & Radiological Health) to resolve open issues. This is not usual but the planning, trip, meeting, and follow-up could require 32 hours. Rarely are trips needed, but instead of the trips - more often some troublesome areas requires Compliance Consultants to actually work with your suppliers to remedy a tedious compliance issue. This remedy can cost 100 hours for which we cover as part of our fee.

Once all issues are resolved, we write the final answers and organize the documents into tabbed final edition. We make multiple copies, hand check each edition for perfection and submit the originals to the FDA. This process requires about 16 hours. We use senior people to ensure nothing can go wrong.

After a calculated period, we contact the reviewer and discover any open issues remain. We conduct a conference call to resolve any issues. We follow up the call with any last minute document changes that may be required to achieve final approval. This process requires about 8 hours.

If a second round of FDA questions occur, after 90 days, we repeat the same process and devote another 120 hours effort for no additional charge to you.

When the decision is reached, we receive typically a fax from the FDA and submit it to you. This finalization process requires about 4 hours.

The total amount of time amounts to 580 hours. We have had projects run more and less. We are efficient but implement a complete, through project.

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

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