HISTORY OF APPLICATIONS OF PAPIMI FOR APPROVAL FOR HUMAN USE IN USA.

1ST. APPLICATION.

THE FIRST APPLICATION WAS BASED ACCORDING TO WHAT IS CALLED 510K REGULATIONS.

510K REGULATIONS  SPECIFY THAT IF A DEVICE IS SIMILAR TO A DEVICE EXISTING IN THE USA PRIOR TO 1975, THEN THIS DEVICE IS AUTOMATICALLY APPROVED TODAY.

AN APPLICATION WAS SUBMITTED THAT PAPIMI WAS SIMILAR TO DIAPULS OF NEW YORK. THE ANSWER OF FDA TO THIS APPLICATION WAS THAT DIAPULS GOT ITS APPROVAL THROUGH THE  COURTS AGAINST THE CAPRICIOUS FDA. SO THE PAPIM  SHOULD DO SAME.THIS WAS THE END OF THE FIRST APPLICATION.

2ND APPLICATION WAS ALSO BASED ON THE 510K REGULATION. THIS TIME THE CLAIM WAS THAT PAPIMI IS SIMILAR TO A DIATHERMY DEVICE EXISTING MANY YEARS IN USA PRIOR TO 1975. ADDITIONALLY IT WAS CLAIMED THAT PAPIMI WAS SIMILAR TO A MODERATE DIATHERMY. THIS ADDITIONAL CLAIM GAVE THE IDEA TO FDA HOW TO DECLINE PAPIMI. FDA ASKED US TO RUN MEASUREMENTS ON A MASS MEAT ON WHICH THERMOMETERS WERE FITTED AROUND AND EXPOSED TO PAPIMI. WE THEN  MADE THE TEST RUNNING PAPIMI AT 5 PULSES PER SECOND THAT WE KNEW  LIMITS EXCESS HEATING. WE KNEW THAT THE HIGHER THE NUMBER OF PULSES THE HIGHER THE HEATING. WE FOUND AT 5 PPS THE MAXIMUM TEMPERATURE THAT COULD BE REACHED AT THE CORE OF MASS MEAT WAS 0.3 CELSIUS DEGREES. THEN THE TEMPERATURE WAS NOT GROWING ANY MORE DUE TO SIMULTANEOUS NATURAL COOLING, COMING TO EQUILIBRIUM.

VERY PLEASED FOR THE SAFE RESULTS ACHIEVED AND HOPPING THAT FDA WOULD BE ALSO PLEASED, WE MADE A RELEVANT REPORT.

FDA REPLIED PAPIMI CAN NOT BE APPROVED BECAUSE DIATHERMIES BY RULE OF THUMB PRODUCE HEAT OF SEVERAL DEGREES. WE REFUSED TO MAKE PAPIMI RUNNING AT MUCH HIGHER PPS RATE, SAY AT 16 PPS THAT WOULD CAUSE THE HEATING AS ARBITRARILY WANTED, BECAUSE WE KNEW THEN THAT PAPIMI PRODUCING FDA'S HEATING WOULD BE REALLY DANGEROUS.  OBVIOUSLY FDA   DEVIOUSLY WANTED US TO CHANGE PAPIMI TO A REALLY DANGEROUS DEVICE TO FIRST APPROVE IT.

3RD. ATTEMPT IS THE CURRENT HALTED PROCEDURE ALREADY DESCRIBED.

THIS PROCEDURE WAS A VERY LONG AND HARD ONE FOR SMALL SUBJECTS, STARTING FROM THE BEGINNING AND OBVIOUSLY COULD NOT BE REFUSED...