FDA review of pre-1976 medical devices

For the announcement, see link.

"The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process."

Below are the 25 types of medical devices approved prior to 1976 that the FDA has ordered reviewed:

1. 21 CFR 868.5610 Membrane lung for long-term pulmonary support.
2. 21 CFR 870.3535 Intra-aortic balloon and control system.
3. 21 CFR 870.3545 Ventricular bypass (assist) device.
4. 21 CFR 870.3600 External pacemaker pulse generator.
5. 21 CFR 870.3610 Implantable pacemaker pulse generator.
6. 21 CFR 870.3680(b) Cardiovascular permanent pacemaker electrode.
7. 21 CFR 870.3700 Pacemaker programmers.
8. 21 CFR 870.3710 Pacemaker repair or replacement material.
9. 21 CFR 870.4360 Nonroller-type cardiopulmonary bypass blood pump.
10. 21 CFR 870.5200 External cardiac compressor.
11. 21 CFR 870.5225 External counter-pulsating device.
12. 21 CFR 870.5310 Automated external defibrillator.
13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form).
14. 21 CFR 872.3960 Mandibular condyle prosthesis (temporary implant).
15. 21 CFR 876.5540(b)(1) Implanted blood access device.
16. 21 CFR 876.5870 Sorbent hemoperfusion system.
17. 21 CFR 882.5800 Cranial electrotherapy stimulator.
18. 21 CFR 882.5940 Electroconvulsive therapy device.
19. 21 CFR 884.5330 Female condom.
20. 21 CFR 888.3070(b)(2) Pedicle screw spinal system (certain uses).
21. 21 CFR 888.3320 Hip joint metal/metal semi-constrained, with a cemented
acetabular component, prosthesis.
22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented
acetabular component, prosthesis.
23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses).
24. 21 CFR 890.5525(b) Iontophoresis device (certain uses).
25. 892.1990 Transilluminator for breast evaluation. 

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