It appears, from recent FDA inspections that we have been present at, that the FDA investigators are intending to use the Affidavit to document the interstate shipment of the medical devices, to support future legal actions.

You must be aware, there is no requirement to sign an FDA prepared Affidavit. Refusing to acknowledge or sign an affidavit cannot be considered a refusal, though the investigators will try to make it appear so. You could ask the investigators, "Where does it state you have to sign an affidavit?" They will have no answer.

The FDA investigator has been training to do everything in their power to get you to sign or acknowledge the information on the Affidavit that they, the FDA investigator, prepared for your signature. The FDA’s Investigations Operations Manual (IOM) Chapter 4, states the following: "Have the affiant read the statement and make necessary corrections (sometimes the investigator will make obvious errors so that you could correct them) before signing the affidavit. Mistakes that have been corrected and initialed and numbered are an indication that he/she had read and understood the statement." It goes on to state: "A concluding paragraph in the affiant’s own handwriting declaring that he/she read and understood the statement are valuable safeguards to counter the possibility that he/she might later claim he did not know what he/she was signing."(As I indicated, the Affidavit is only used by the FDA to document information supplied by the company. It cannot in away be of any value to the company.

The FDA’s IOM goes on to say, "Before the individual signs the statement it should be sworn to by asking the person, "Do you swear (or affirm) that this statement is true?"(though, I have never seen an FDA investigator actually request that.)

Concerning refusal to sign the IOM states the following, "Even if it is apparent that the company refuses to sign a statement setting forth the facts he/she has revealed, the statement should be prepared as described above. Either read the statement to the company or have him/her read it, preferably before a witness. Request the company to correct and initial by his/her own hand any mistakes. Elicit from him/her an acknowledgement that the statement is true and correct. Ask him/her to write in his/her own hand at bottom of the statement, "I have read this statement and it is true, but I am not signing it because…." Failing that, declare at the bottom of the affidavit that you recorded the facts above as the company revealed them, that the dealer read the statement, and avowed the statement to be true. Attempt to have any witness to the statement sign the affidavit with his/her name and address."

If the FDA prepares an affidavit, attempted to make a copy of the affidavit, but do not let the investigator know you are making a copy. Let the investigators know that all affidavits have to be reviewed by corporate counsel before signature can be made.

Again, it should be your company’s policy not to acknowledge an FDA affidavit. If the FDA attempts to have to hear or sign an affidavit, tell the investigator that you will not entertain listening to or that you he could read the affidavit to you but you will not anyway acknowledge any facts as to whether they are true or false. If you make this statement before the investigator has a chance to read the affidavit he would attempt to scare you by stating that you are refusing to cooperate. Do not fall for that trick.