Amanda Lowe, president of Digital Pathology Consultants, posted a very illuminating blog note recently in Keith Kaplan's Digital Pathology Blog (see: Digital Pathology Misconceptions Debunked by Digital Pathology Consultants). It's definitely worth a look. Misconception #1 caught my attention and I reproduce it below:
Misconception #1: The FDA has not approved digital pathology; therefore, it must not be safe.
The FDA does not regulate laboratories and it does not issue blanket approvals for specific applications like digital pathology. The reality is that the FDA approves the digital pathology hardware and software produced by a manufacturer for a specific intended use (e.g., primary diagnosis of H&E slides). Digital pathology manufacturers are required to go through a premarket approval (PMA) process to have their systems approved as a Class III medical device; this process takes time and is very costly for manufacturers. These hurdles have made it difficult for manufacturers to apply for FDA approval, but they are working on it. However, several digital pathology manufacturers have received FDA 510(k) clearances for specific manual and semi-quantitative analysis of specific IHC assays including HER2, ER/PR, Ki-67, and p53.