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FDA Regulation of Medical Device Advertising and Promotion complaint definition fda

FDA Regulation of Medical Device Advertising and Promotion Posted on November 17, 2011 at September 4, 2015 by Areta L. Kupchyk 741 0

There are tens of thousands of medical devices being advertised and promoted in the U.S. The Food and Drug Administration (FDA) has statutory authority to regulate the advertising and promotion of “restricted” medical devices as well as any medical devices that are not authorized by FDA for sale or distribution for their intended use. A “restricted device” is a device that can only be sold, distributed or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

Devices that are not authorized for marketing include experimental (or investigational) devices as well as approved or cleared devices that are marketed for uses not on their approved or cleared labels (“off-label uses”). In both cases, the unauthorized intended use of the device would render the device “misbranded.”

A medical device is misbranded if its advertising is “false or misleading” in any way. The false and misleading standard also applies to a product’s labeling and “other descriptive printed matter.” A device is also misbranded if its label does not contain certain required information, such as: (1) the generic name of the product in type at least half the size of the trade name; (2) a brief statement of the intended uses and warnings, precautions, side effects and contraindications; and (3) when needed, a description of the device’s components. (21 U.S.C. § 352(q)).

By way of background and to appreciate the full scope of FDA’s authority over products that are considered to be medical devices, it is interesting (if not mind-boggling) to review the broad statutory definition of a medical device. A medical device is defined as:

“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) 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

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which complaint-definition-fda-rid-0.html. moncler outlet store locations is not dependent upon being metabolized for the achievement of its primary intended purposes. (21 U.S.C. 301(h)(emphasis added).”

From this definition, it’s clear that “intended use” is the key in determining regulatory status and compliance. FDA determines the intended use of a medical device by looking at a wide body of evidence, such as: “labeling claims, advertising matter, or oral or written statements” or circumstances that show the medical device is “with the knowledge of [the manufacturer] offered and used for a purpose for which it is neither labeled nor advertised.” (21 C.F.R. § 801.4) (emphasis added). In determining whether labeling or advertising is misleading, the FDA considers everything : statements or any other representations, explicitly made or implied by “word, design, device or any combination” of these, as well as the “extent to which the labeling or advertising fails to reveal facts that are material, such as information about the risks from using the device either on or off-label. (21 U.S.C. 301(n)).

Device advertising is different from drug advertising. The most obvious difference is the complete absence of any regulations to guide medical device companies in developing their advertising. By contrast, the FDA has an extensive and detailed regulation (21 C.F.R. Part 202) that sets out the requirements as well as the prohibitions for drug advertising.

For example, FDA regulations require drug advertising to include fair balance between the benefits and risks of the product, as well as specific language and size of print. The drug regulations explicitly prohibit, among other things, unsubstantiated efficacy, comparability and superiority claims. Although the same detailed regulations have not been imposed by FDA, the agency applies many of these same restrictions on medical devices.

Although the FDA is prohibited from the regulation of “commercial free speech” under the First Amendment, and may not impose preapproval requirements for either drugs or devices, the FDA has carved out an exception for drugs when the drug is approved through an accelerated pathway or when the FDA finds that the drug pose such risks that preapproval of advertising is needed to protect the public health. By contrast, the FDA has not imposed a similar preapproval review for medical devices.

The FDA enforces the advertising and promotion of medical devices in a variety of ways. The first and obvious way is by reviewing labeling and other publicly disseminated materials. The FDA can find advertising and promotional materials from any source or by any means, such as reading product web pages and surfing the Internet to learn how a device is being used by consumers. In addition, FDA compliance reviewers attend trade shows and scientific/medical conferences, read periodicals and inspect company facilities.

Of great concern to most companies is having a level playing field when competing in the market. To this end, many companies file trade complaints with the FDA in which they detail violations, provide copies of the violative materials and analyze the legal basis for FDA to take an enforcement action. Such letters attempt to make it as easy as possible for FDA to take action. The FDA states that it reviews all complaints, but whether the FDA will take action is never revealed. Nor will the FDA inform the complainant when it does take action. To a lesser extent and without as much analysis, the FDA receives complaints from healthcare providers, and sometimes consumers.

To leverage its limited resources, the FDA focuses first on higher risk medical devices in addition to unapproved medical devices that have the potential to lead to injury. For example, if the agency must make a choice, the FDA would be more likely to focus on cardiac implants instead of exercise equipment.

From the small amount of information and guidance the FDA has offered to date, we know how the FDA would view certain statements and representations. For example, companies are permitted to state that a medical device is approved if, in fact, the device has been “approved” under a premarket application (PMA), which is required for high risk devices. However, the FDA does not permit the use of the phrase “FDA approved” when referring to a device brought to market via the 510(k) notification process.

A 510(k) device is generally of low to moderate risk. Despite the premarket submission requirements, a 510(k) medical device is not “FDA-approved.” Rather, such a device is “cleared” by the agency.

With respect to PMA devices, a manufacturer must demonstrate the safety and efficacy of its medical device typically with clinical studies. A manufacturer of a 510(k) medical device only needs to show that the device is substantially equivalent to a legally marketed 510(k) device, referred to as the predicate device. If substantial equivalence is shown, the device is considered as safe and effective as the predicate without presentation of independent evidence of safety and effectiveness. To say a 510(k) device is approved would be false and misleading and, thus, prohibited.

The world of medical device regulation is complex and often maddening. But a surefire way to show your familiarity with medical devices is to be sure to refer to a 510(k) device as cleared for its intended use and a PMA device as approved.

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FDA warning letter disallows 14 Metagenics products as medical foods 1 comment By Hank Schultz Hank Schultz , 13-Sep-2013 2013-09-13T00:00:00Z Last updated on 13-Sep-2013 at 18:29 GMT 2013-09-13T18:29:16Z

Related tags: Unapproved new drugs , Adulterated supplements , Medical food , Warning letters

UltraClear is one of the Metagenics products that FDA says do not qualify as medical foods.

Metagenics, a prominent California-based dietary supplement manufacturer that specializes in medical foods and supplements sold through the practitioner channel, has received a warning letter in which FDA says a number of its medical foods are mislabeled and have claims that make them unapproved new drugs.  The action signifies an FDA push toward reigning in the category, an expert said.

“Medical foods have long existed as a category. FDA is taking a closer look at that category,” Jim Lassiter, president of Laguna Beach, CA-based consultancy Ingredient Identity told NutraIngredients-USA.

Warning letter from website review

The warning letter, dated Aug. 13, 2013, resulted from a review of the company’s website. Such website reviews and warning letters do not result from the same inspection‑483-warning letter protocol as a GMP inspection;  when FDA finds noncompliant website language it can and does issue warning letters immediately.

Medical foods are a lesser known subcategory of dietary supplements.  To use the definition in the guidance (which itself parrots the language in the defining regulation), a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” 

Additionally, a medical food must be a product formulated specifically to address a medical condition that gives rise to a specific nutritional deficiency or to address the needs of patients who have specific difficulties in absorbing certain nutrients or ingesting certain foods as a result of a specific disease. For example, if a given condition gave rise to a potassium deficiency, a banana marketer could not brand his products as medical foods.

14 products cited

FDA took issue with 14 products that Metagenics was selling as medical foods. The products are branded to address the needs of patients suffering from chronic fatigue syndrome, fibromyalgia, leaky gut syndrome, metabolic syndrome, cardiovascular disease, inflammatory bowel disease, type 2 diabetes, atopic disorders such as eczema, rhinitis, and allergy-responsive asthma, bariatric patients both before and after stomach reduction surgery and periphereal artery disease.

In the warning letter, FDA said it believes that the medical foods regulation and guidance to “narrowly constrain the types of products that fit within this category. In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.”

In the test of the warning letter, FDA cited for every one of the products the following bit of boilerplate: “ FDA is not aware of any distinctive nutritional requirement for patients with (disease name), nor is FDA aware of any evidence that patients with (disease name) have a limited or impaired capacity to ingest, digest, absorb, or metabolize any specific nutrients.”

Also included in the list of Metagenics’s products were two meant for patients suffering from Type 2 diabetes.  In the draft guidance, FDA specifically excluded Type 1 and Type 2 diabetes as conditions for which a medical food can be marketed and sold.

FDA concludes that “these products are misbranded within the meaning of Section 403(a)(1) of the Act because their labeling is false or misleading in that the products are labeled as a medical food but do not meet the definition of a medical food.”

Double whammy

Once the Metagenic’s products have been disallowed as medical foods, they fall into the category of unapproved new drugs, as far as FDA is concerned.   The claims which might have function in the medical food realm become unallowed disease claims if the products are intented as supplements. An example would be a product that Metagenics says provides “specialized nutritional support to address…liver detoxification function in patients with chronic fatigue syndrome.”

FDA concludes the discussion on disease claims with this: “Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs.’ ”

Metagenics response

In a statement in response to the warning letter the Californian company said : "As an industry leader in the development of medical foods, we have great confidence in the unsurpassed quality and safety of our products as supported by well-designed clinical studies and nutrition research.

"Metagenics recently received a Warning Letter from the FDA related to the categorization of the company’s products as medical foods. The letter was received concurrent with the issuance of new guidance for medical foods from the FDA, which includes potential changes to current practice. The letter from the FDA only addressed the positioning of Metagenics’ line of products as medical foods, but raised no concerns regarding the quality, manufacturing or safety of our products."

Renewed scrutiny

So is this an example of FDA using a draft guidance as a basis for enforcement? Has the category become somewhat overbroad during its long market history? Does it now include products that don’t perfectly match the regulatory definitions?

“I do think that they [FDA] are sending that message,” Lassiter said. “I think their target selection (Metagenics) was part of that message.

“The timing of the release of the warning letter and the timing of the release of the updated draft guidance was not a coincidence. FDA is saying, here’s our point and here’s how we are making it.”