From VINCE BOEHM:
I’m in shock. Really in shock. I never thought I’d see this.
It may come as a shock to some of you; but, Shock machines have never been approved by the FDA for safety or efficacy. These were “grandfathered” into the system when the FDA assumed jurisdiction over these items in 1976.
All machines manufactured after this date were routinely approved, as were things like female condoms, on a statement by the manufacturer that these were “Substantially equivalent” to the earlier devices.
This week the Agency told the makers of 25 different types of medical devices marketed before 1976, to submit safety and effectiveness data within 120 days. Electroconvulsive therapy devices are included. <see blog below WSJ article>
The ECT makers must submit proof of safety and efficacy to the FDA by August, 7, 2009. If the data submitted is not up to par, the FDA intends require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones. For some mysterious reason, Congress ordered the FDA to do this in 1990. . . . . but it NEVER HAPPENED!
APRIL 8, 2009, 6:10 P.M. ET
Medical Devices Face New Scrutiny From FDA
By KEITH J. WINSTEIN
The Food and Drug Administration asked several medical-device makers to justify their products’ safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.
The request covers automatic external heart defibrillators from Medtronic Inc., Royal Philips Electronics NV and Zoll Medical Corp.; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; a heart pump from Abiomed Inc.; and several other categories of products.
The move presents the possibility that the companies will have to pay for expensive clinical trials for products already on the market, unless they can persuade the agency to reclassify them as less risky.
The agency’s request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.
But despite several attempts during the 1990s, the FDA hasn’t finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing — called a 510(k), after a section of federal law — that they are “substantially equivalent” to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.
The Government Accountability Office criticized the delay in January. The agency said it will issue regulations Thursday asking makers of high-risk medical devices who had been allowed under the easier process to submit evidence to the agency backing their products’ safety and effectiveness.
The FDA will then either reclassify the devices into a less-risky category in which the 510(k) process is routinely allowed, it said, or require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones.
Mary Long, an agency spokeswoman, said it could take several years for the agency to finish the process. Manufacturers would be granted a grace period to submit enough evidence backing their devices under the more-rigorous standard. “It is a priority, but it will really depend on the kind and amount of information we get on each type,” she said.
Write to Keith J. Winstein at firstname.lastname@example.org
By Jennifer B. Davis –
The April 9, 2009 Federal Register will contain the official notice of an FDA order requiring manufacturers of 25 types of Class III “preamendments” devices to submit information on such devices, including adverse safety and effectiveness data not already submitted to the agency, by August 7, 2009. The order also applies to manufacturers of devices marketed based on 510(k) determinations of “substantial equivalence” to the 25 identified preamendments devices. FDA warns that failure to comply is a prohibited act, and will cause any affected device to be to be misbranded. The agency also says it “does not anticipate extending the time for submitting the required information,” and “will use its enforcement powers to deter noncompliance.” FDA intends to use the information submitted to decide the final classification for such devices.
A news release posted on April 8, 2009 on the agency’s website calls the order a “first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress.” The FDA Amendments Act of 2007 ordered GAO to study FDA’s 510(k) process. The GAO report found that the agency’s process for reclassifying or requiring PMAs for class III devices was incomplete, and recommended completion of that task to ensure the most stringent (PMA) review process for high-risk devices.
Section 513 of the FDC Act (21 U.S.C. § 360c), added by the Medical Device Amendments of 1976 (“MDA”), requires FDA to classify all devices into one of three risk-based categories: Class I, Class II, or Class III. Devices assigned to Class III, representing the highest risk, must obtain premarket approval from the agency before they can be marketed. 21 U.S.C. § 360e(a). However, under section 515(b)(1) of the Act (21 U.S.C. § 360e(b)(1)), devices initially assigned to Class III, which were marketed prior to the May 28, 1976 enactment of the MDA – so-called “preamendments” devices, do not require submission of a premarket approval application (“PMA”) until after FDA issues a final rule requiring a PMA for that device, or, FDA publishes a final classification placing the device in Class III. In addition, the statute allows devices introduced to the market on or after May 28, 1976, which can be shown to be “substantially equivalent” to a Class III pramendments device, to be marketed through a 510(k) instead of a PMA unless and until FDA calls for a PMA, or finally classifies the preamendments device in Class III.
As of May 1994, there were approximately 149 preamendments devices which FDA had initially classified or proposed to classify in Class III. The agency has since reclassified (into Class I or II), or published a regulation requiring PMA submission for 122 of those devices, leaving 27. The order to be published in the April 9, 2009 Federal Register addresses the following 25 devices. (FDA has already initiated the process for the other two 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 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.
Manufacturers of the above-listed devices must, by August 7, submit “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” (e.g., medical device reports, reports of corrections and removals). Additional details respecting the format and content for such submissions can be found in FDA’s order.