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What others charge Our typical 510(K) submission project requires 580 hours. Some are more, some are less. We have tabulated this time to illustrate the detail to which we operate for your benefit. The consultants firms used in Example ONE and TWO simply operate at a less involved level. We illustrate two different examples.

Example ONE. A large, high profile D.C. FDA consulting firm that prides itself in hiring former FDA reviewers, quotes as of September 2001 a rate of $235 per hour to do a 510(K). They also estimate that 75% of their 510(K)'s cost no more than $7000. This calculates to approximately 30 hours worth of work. At Compliance Consultants we consider this is unrealistic and these figures indicates the kind of work, regardless of their reputation you should expect- very little for a lot of money.

This indicates that either they · simply peruse through a prepared 510(K) prepared by the staff of a medical device conglomerate or · if the task falls within the other 25% group and the major D.C. FDA consulting firm spends the necessary 580 hours that we do, this would amount to a charge of $136,000 to create the quality submission that we create for much less. At Compliance Consultants we charge much less and give you more.

Example TWO. A small suburban Maryland FDA consulting firm offers to do 510(K)s on a fixed fee basis for $7000. They list essentially Class I devices not Class II devices. They do not identify the limits of their activities such as what we have defined. If they were to spend 580 hours (such as what we do) they would be charging under $12 per hour. We doubt that qualified engineers work for this rate. We doubt that this company compares to our activities. This is simply a bait and switch price. No competent regulatory group can spend 580 hours and only charge $7000. We would you suggest you study their proposal with great trepidation.

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