The Institute of Medicine has curbed enthusiasm for the FDA’s medical device approval process.

The FDA has been advised that its 501(k) medical device approval process is not effective:


In 2009 the FDA requested the Institute of Medicine (“IOM”), a part of the National Academy of Sciences, to undertake a study of its 510(k) approval process to determine its effectiveness and to make recommendations to improve and strengthen it.  It hardly imagined that the recommendation out last week would be to dump it altogether. The 510(k) clearance process for moderate risk devices such as hip replacement devices, external heart defibrillators and hospital based pumping devices provides an easier road for medical device manufacturer’s to obtain regulatory approval of new technological advances in medical devices without going through the more cumbersome, comprehensive and expensive PMA or premarket approval process required for higher risk products….

In order to qualify for the 510(k) approval process a manufacturer must establish that a product is “substantially equivalent” to a product currently on the market. This is a “piggy  backing” process without an independent examination of product safety. The IOM came to the conclusion that the 510(k) process cannot be transformed into a reliable pre-market and post market screen for the safety and effectiveness of Class II (moderate risk) devices. The IOM determined that the FDA lacks a statutory basis to achieve an integrated premarket and post market regulatory framework designed to effectively protect public safety.


The IOM recommended further that the FDA speed up the process of review as to what devices should be included in Class III (high risk) categories. It encourages the FDA to base its decisions on “sound science,” with a process that is “clear, predictable, straight forward and fair….”

The is the first of two great posts by health care lawyer Greg Piche, who write the Singularity Heath Law Blog out of Denver, Colorado.  Our law firm has represented manufacturers of technologies that could be considered medical devices and has engaged us for legal advice concerning the limits of FDA jurisdiction and the 510(k) medical device review process.

In a second great post, health care attorney Greg Piche writes about a turf battle — very common in health care — involving, among all things, teeth whitening:

On July 14, 2011, an administrative law judge took the North Carolina Board of Dental Examiners to task for limiting “teeth whitening” services to dentists in North Carolina.  The Board had sent cease and desist and similar orders to 42 non-dentist providing teeth whitening services accusing them of the unlawful practice of dentistry. The Board previously filed a federal law suit seeking to enjoin the interference of the FDA on the basis that it lacked jurisdiction over the Board, that the Board was immune under the “state action” doctrine and that the FTC was constitutionally prohibited from preempting state law.  It lost on all counts.

In In Re: North Carolina State Board of Dental Examiners, FTC No. 9343 (July 14, 2011), the ALJ ruled that the Board had violated Section 5 of the FTC Act (also Sec. 1 of the Sherman Antitrust Act) by engaging in a contract, combination, or conspiracy in restraint of trade in the relevant market by freezing non-dental teeth whiteners out of the  North Carolina geographic market and the teeth whitening product markets.

Piche concludes: The case suggests future FTC action where state boards are dominated by practitioners voting in support of their own financial interests.

The notion that a board itself could be haled into court for monopolistic practices in a health care turf battle is interesting, as it grants more power to practitioners outside that health care regulatory board’s jurisdiction to challenge Board rulings that infringe on those health care professionals’ practice areas.  As suggested, turf battles are rife in health care, going at least back to the American Medical Association’s historic battles against homeopaths and chiropractors, and other "cult" practitioners (as chiropractors were called by their rivals during the early days).


Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets.  As a corporate and regulatory attorney who has also handled litigation matters, Mr. Cohen represents conscious business leaders in a transformational era.

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