CAMLAW: Complementary and Alternative Medicine Law Blog

FDA Medical Device Law and State Legal Issues Affecting MDs and Other Health Care Practitioners

Doctors, psychologists and other practitioners who use medical devices to assess patient's "energy fields" need legal advice about FDA rules, medical board discipline, malpractice liability and related legal risks.

 

Let's start with the definition of a medical device given by the federal Food, Drug & Cosmetic Act, because the first issue in any energetic diagnosis with an instrument, is whether the activity is potentially regulated in some way by the FDA.

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

In assessing the FDA status of a medical device, we turn to several searchable databases:

·         Premarket Notifications (510(k)s). Medical device manufacturers are required to submit a premarket notification or “510(k)” if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.  This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.[1]

·         Registration & ListingThis searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers.

·         Product Classification. This database contains medical device names and associated information developed by the Center for Radiological Health (CDRH) within the FDA.  It includes a three letter device product code and a Device Class that refers to the level of CDRH regulation of a given device.

We also search the Code of Federal Regulations (“CFR”).[2] The reason is that the devices listed in the CFR are already considered exempt from 510(k) premarket notification to the FDA, and serve as predicate devices for those new devices, for which manufacturers are seeking 510(k) clearance.

As the FDA explains in its discussion of 510(k) clearances:

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories [i.e., Class I, II or III].

In order to receive 510(k) clearance, the medical device must be “substantially equivalent” to an already approved device[3]--i.e., to a “predicate device.” Once a company receives 510(k) clearance, it need not submit the lengthier and more onerous premarket approval application (PMA).

Ideally, when a physician is using a medical device in practice, the device should have 510(k) clearance.   However, we know that many such devices are being sold to the public in violation of the FDCA. Although, as noted, the FDA tends to initiate enforcement action concerning medical devices against manufacturers and distributors and not health care practitioners, since professional health care practices come under state law, the FDA still may exert jurisdiction, and/or report the matter to a state medical board. Therefore, if the device in question is not approved, we should at least search the FDA databases to determine whether the device itself has predicate devices that wouldlikely be considered “substantially equivalent,” should the manufacturer decide to file a 510(k) application for the device in question.

Note that every 510(k) submission includes a Statement of Indications for Use. The Statement:

should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use. Once the review is complete, FDA will include the Indications for Use Statement with the Substantial Equivalence (SE) letter to the applicant and make it available to the public on the Internet.

Effectively, this means that the 510(k) clearance only goes to approval of specified indications for use.[4] 

            The final search would be of FDA warnings letters for FDA correspondence with companies deemed to have crossed the line into violating FDCA medical device rules.

            Normally, the FDA does not take enforcement action against physicians, since medical practice comes under state law and the FDA is responsible for enforcing the federal Food, Drug & Cosmetic Act (“FDCA”) and has no jurisdiction over the practice of medicine However, use of an unapproved medical device could conceivably lead to malpractice liability and/or medical board discipline.

 

            Use of unapproved medical devices also should be disclosed in a robust informed consent form that an attorney versed in law governing complementary and alternative medicine should prepare.



[1] For riskier devices, one can search Premarket Approvals (PMA)Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices (i.e., those devices considered the riskiest).  An approved Premarket Approval Application (PMA)  is, in effect, a private license granted to the applicant for marketing a particular medical device.

[2] According to the FDA: “The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.” On the other hand, the Federal Register (FR) “is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. Proposed rules are initially published in the Federal Register for public comment and subsequently published in the Code of Federal Regulations after the rule is final. Final regulations published in the FR are subsequently placed or codified into the printed edition of the Code of Federal Regulations (CFR) on an annual basis. You can find recently published FR's on the Regulations.gov web page.”

[3] A device is substantially equivalent if, in comparison to a predicate it:

·         has the same intended use as the predicate; and

·         has the same technological characteristics as the predicate; or

·         has the same intended use as the predicate; and

·         has different technological characteristics and the information submitted to FDA;

o    does not raise new questions of safety and effectiveness; and

o    demonstrates that the device is at least as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable..

[4] As stated in one FDA warning letter:

Failing to submit a 510(k) as required by the FDA regulations discussed above renders a device misbranded under section 502(o) of the Act, for failure to notify the agency of intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. A review of our records also revealed that your firm has not listed its product as required by section 510(j) of the Act. The failure to comply with this requirement also causes your device to be misbranded under section 502(o). Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may legally market your device, your product is also adulterated under section 501(f)(1)(B) of the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval before marketing, the notification required by section 510(k) is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. (21 CFR 807.81 (b)).

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Michael H CohenMichael H Cohen
Founder
The Los Angeles / San Francisco / Bay Area-based Michael H Cohen Law Group provides healthcare legal and FDA legal & regulatory counsel to health & wellness practices and ventures, including health technology companies (medical devices to wearable health and nanotech), healthcare facilities (from medical centers to medical spas), and healthcare service providers (from physicians to psychologists).Our legal team offers expertise in corporate & transactional, healthcare regulatory & compliance, and healthcare litigation and dispute resolution, in cutting-edge areas such as anti-aging and functional medicine, telemedicine and m-health, and concierge medicine.Our Founder, attorney Michael H. Cohen, is an author, speaker on healthcare law and FDA law, and internationally-recognized thought leader in the trillion-dollar health & wellness industry.
 

 

 

 

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