Excellent post from Dr. Keith Kaplan. Highly recommended reading and, hopefully, will generate comments for CAP and industry in moving forward with digital pathology. He presents an intriguing solution to address what will now be a formidable challenge to obtain regulatory approval for whole slide scanning and primary digital diagnosis.
The FDA's byzantine inscrutability and labyrinthine logic regarding pre-market approval for whole slide scanning systems will set the field back several years. This might be good (indeed, great!) news for pathologists nearing retirement but, frankly, is very disappointing to those of us champing at the bit to move forward with digital slide imaging and implementing digital pathology into daily practice.