This is where all download will be listed, utilizing the Page Add plugin.
File Name | S22-Policy-Stoa-56-NEG-Close510kPathway.docx |
File Size | 355.68 KB |
Date added | February 23, 2022 |
Category | Archived, Policy (Stoa) |
Author | Vance Trefethen |
Resolved: The United States federal government substantially reform the use of Artificial Intelligence technology
Case Summary: There are 4 “pathways” a new medical device can obtain clearance by the FDA for public marketing: 510K, De Novo request, and PMA (pre-market approval).
PMA – is the most stringent type of regulation. It’s used for “Class III” devices, which are those that perform very critical functions involving risk to human life. (Classes I and II are less critical / less risky)
De Novo – is for a new medical device that is different from anything previously developed, but can be shown to be low risk and needing only minimal testing to assure safety.
510K – also known as PMN (Pre Market Notification) is the easiest approval process. The device maker submits a 510K request 90 days before selling it on the market, asserting to the FDA that the device is similar or substantially equivalent to an existing already-approved device that was previously approved without PMA.
Exempt – a Class I device that doesn’t pose any risk can be marketed without FDA approval, as long as they simply register it with FDA.
AFF probably believes too many AI devices are being approved too easily by 510K and wants them to go through the other 2 more rigorous “pathways.”
Understand one key issue: When a device that was approved under 510K breaks or causes harm to the patient, the injured patient can sue the manufacturer for compensation (that’s called “tort liability”). But a device approved under PMA is immune to such lawsuits. Anyone injured with a PMA approved device is out of luck and will be thrown out of court. Here’s the problem: FDA has no expertise or skills to evaluate AI devices. So, the same devices that are on the market today under 510K will be approved under PMA without any added safety benefit (because FDA doesn’t know what it’s doing). The only difference will be that injured patients will go uncompensated.