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US FDA issues notice on preamendment Class III medical devices

(Published April 2009)

The FDA has posted an order in the Federal Register (Thursday, April 9, 2009, Vol. 74, No. 67, p.16214-16217) requiring manufacturers of 25 types of Class III medical devices marketed prior to 1976 to submit “a summary of, and a citation to, any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information concerning the devices…”

The summaries and citations are due by August 7, 2009.

Based on the information submitted, the FDA will determine whether the device should be reclassified to one of the following conditions:

  • Submission of a PMA (Premarket Approval)
  • Notice of completion of Product Development Protocol
  • Reclassified to Class I or Class II


The US Federal Register notice listed the following 25 devices:

  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 counterpulsating 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. 21 CFR 892.1990 Transilluminator for breast evaluation.
     

Thus, manufacturers currently marketing these preamendment Class III devices must “provide a summary of, and citation to, any information known or otherwise available to them respecting the devices, including adverse safety and effectiveness data that has not been submitted under section 519 of the act.”

Here is a copy of the FDA News Release and a link to the Federal Register notice from April 9, 2009.

Obviously, if you manufacture any of these devices, you should review the FDA press release and Federal Register notice carefully and take appropriate action.

We will continue to keep you informed of regulatory changes as they happen.

Best Regards,

Evangeline Loh, PhD, RAC
Vice President of Regulatory Affairs


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