Here are five takeaways:
1. The two devices are the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal-metal semi-constrained with an uncemented acetabular component.
2. The new PMA requirement for the two types of devices comes as FDA believes there is insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices.
3. By May 18, 2016, the agency says PMA applications must be filed with the agency if a manufacturer wants to continue marketing these two types of Class III metal-on-metal total hip replacement devices and/or market new versions of such metal-on-metal total hip replacement devices.
4. According to the FDA, the PMA applications for such devices should include:
- Any known risks, or risks that should be reasonably known;
- The effectiveness of the device;
- Full reports of all non-clinical and clinical information from investigations on the safety and effectiveness of the device for which pre-market approval is sought.
5. The FDA previously directed five manufacturers currently marketing metal-on-metal total hip implants in the United States to conduct post-market surveillance study plans.
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