The IOM (Institute of Medicine) on 7/29/11 stated that the 510(k) approval process was so flawed that it should be scrapped - yet that is how the FDA releases almost all orthopedic implants to the U.S. market . . . and there is currently no independent post-market registry, either! That results in medical and legal purgatory for patients who receive failed products and higher healthcare costs for U.S. citizens. (Joleen Chambers)
Clarimed is a fabulous new company that provides meaningful data that is accessible to all stakeholders so that the U.S. can make life-enhancing decisions about medical devices.
Timeline of Orthopedic Prosthetics & Implants Approvals
Overview of Approval Types
Supplemental FDA PMA Filings for Orthopedic Prosthetics & Implants
- PMA supplements are required for all changes that affect safety and effectiveness of a device, unless such change involves modifications to manufacturing procedures or method of manufacture. These types of manufacturing changes require a 30-day Notice or, where the FDA finds such notice inadequate, a 135-day PMA supplement.
- 647 supplemental filings have been approved by the FDA for Orthopedic Prosthetics & Implants.