When is a drug a device?


According to the United States Food and Drug Administration (FDA), a drug is any product “intended for use in the diagnosis, cure, alleviation, treatment or prevention of disease” and “articles ( other than food) intended to affect the structure or any function of the body of man or other animals’, including the active pharmaceutical ingredients and other medicinal components.

A medical device, on the other hand, is “an instrument, apparatus, instrument, machine, artifice, implant, in vitro reagent or other similar or related article. […] for use in diagnosing disease or other conditions, or in curing, alleviating, treating or preventing disease “,” intended to affect the structure or any function of the body […] which does not achieve its main objectives by chemical action inside or on the body ”, and“ which does not depend on being metabolized to achieve its main objectives ”.

The distinction between drugs and devices should therefore be relatively straightforward – but in reality the categorization of some medical products has proven to be less straightforward.

In April 2021, the U.S. Court of Appeals for the District of Columbia told the FDA that it had misdefined a product. The regulator had previously classified Genus Medical Technologies’ barium sulfate contrast agent, or Vanilla SilQ, as a drug – but the court ruled that the product should be considered a medical device instead. The FDA has been advised that products meeting the definitions of drugs and devices should, in most cases, be regulated like the latter.

Following the decision, the FDA has announced that it will post a Federal Registry notice listing the products it determines “tentatively” to “transition to device status,” and welcomes comments from stakeholders on the products. who should be transferred and how.

The agency said all products that meet the definitions of both a drug and a device should be regulated as devices – but what will this move mean for companies whose products enter this space?

The gray area between drugs and devices

The clearest way to determine if something is a drug or a device is to look at its primary purpose – but as we saw in Gender vs FDA, even that can be debatable.

Isabella Schmitt, director of regulatory affairs at the contract research organization Proxima, says imaging agents, nanoparticles and other chemicals can be difficult to define.

“The route of administration can bend things; is it an injectable or is it ingested? Is it administered topically? This is another question that can get a little confusing, ”she explains.

“The main mechanism of action is usually this [a product’s classification] is definitely based on – but there may be secondary mechanisms of action that may confuse the determination of the primary mechanism and to what extent that secondary mechanism of action contributes to the therapeutic effect or to the diagnostic effect.

Drugs vs devices: the regulatory process

Within the FDA, the Center for Drug Evaluation and Research manages drug regulation, while the Center for Devices and Radiological Health deals with medical devices.

All potential drugs must be tested on animals before a drug manufacturer can submit an Investigational New Drug Application (IND) to the FDA. If an IND application is accepted, the product moves to human clinical trials, after which the company may seek market approval through a New Drug Application (NDA). Once approved, the drug goes through post-marketing surveillance to monitor the safety and effectiveness of the drug in patients.

Medical devices are classified in Classes I, II and III, with regulatory control of the product increasing as the classes progress. Most Class I devices do not need to submit a pre-market notification, known as 510 (k), while most Class II devices require a 510 (k) and most Class III devices require pre-market approval.

Device manufacturers and initial distributors must register their establishments with the FDA before registering their product with the agency. Devices requiring a 510 (k) will only be approved for commercial distribution if they are found to be “substantially equivalent” to another device on the market in the United States, or to a device that the FDA has determined to be substantially equivalent. equivalent.

Class III devices that require pre-market approval are high-risk devices that “present a significant risk of disease or injury, or devices that are not substantially equivalent to Class I and II predicates through the process. 510 (k) ”. Unlike the relatively straightforward regulatory requirements for Class I and II devices, companies seeking approval for Class III products must go through a longer process and submit clinical data to support their request.

“It’s much easier to go through the device process than it is through the drug process,” says Schmitt. “Both with the interactions with the FDA, and the submissions and requirements for things that you need to establish for safety and effectiveness.”

Switch from drug to device

Because the FDA regulatory requirements for drugs and devices are very different, transitioning a product from one status to another is not a straightforward process – and for companies whose products are similar or in the market, it could mean less time and money.

“The financial implications could be that they spent a lot of money early in development, thinking it was a drug when it was actually a device,” says Schmitt. “Some of the work they’ve done might be rendered useless if they’ve gone far enough and done clinical trials; depending on the evaluation criteria for these clinical trials, they may not answer questions to establish the safety and efficacy of a device. ”

In October, US drug maker Eyenovia announced that its pupil dilation product Mydcombi – for which the NDA was accepted by the FDA in March – would be upgraded from drug to drug-device combination status due to the Kind decision. The company’s stock price fell about 35% on the pre-market after the announcement.

However, companies whose products are in the development stage would generally benefit from being regulated as a device rather than a drug, due to less stringent regulatory requirements. As Genus told the court in April, it would cost around $ 60,000 to get regulatory approval for a device, while it would cost a drug to market over $ 500,000, plus annual costs of more. of $ 186,000 to keep it.

“Yes [a product] was switching from one drug to another, it would probably be beneficial from a financial point of view, as [the company] would probably have less of a regulatory burden, ”explains Schmitt.

“They wouldn’t have to establish the same safety and efficacy parameters as they would for a drug; depending on where they are in their development pipeline, there would likely be fewer clinical trials involved, and potentially less preclinical work would need to be done. ”

Mary Beth Ritchey, director and owner of the Med Tech Epi consultancy group, said the financial implications of a new designation will vary depending on which stage of the regulatory or commercialization process the product is in.

“A company whose designation changes midway through preparation for a review, or during the FDA review process, is likely to have a higher initial cost for the newly created ‘device’ compared to “Drugs” currently on the market, ”Ritchey said. “Conversely, companies whose products are still in development would be able to use the cheapest device regulatory route to market.

“It is not clear how companies marketing products that are already available would move away from the ongoing annual costs associated with drug regulation and move to device designation. However, given the difference in cost, these companies may find it profitable to go the regulatory route for devices. ”

Schmitt hopes products that have been on the market for years and are now slated for transition will be granted vested interests by the FDA, rather than having to re-apply or submit additional data to the regulator.

“I hope they will benefit a lot of these companies, as it would be quite frustrating for them to have to establish new security and efficiency,” she says. “Or, hopefully they would be able to use a lot of the data they used for drug submissions to support device submissions, and they would work with these companies that way.”

The FDA declined to comment on the Kind decision, or when the Federal Registry’s notice regarding products intended for transition should be published.

Drug or device: how can manufacturers be sure?

For drug and device companies unsure of where their product fits, Schmitt recommends contacting the FDA’s Office for Combination Products (OCP) for clarification before applying for the agency designation.

“Historically, the FDA leans on the conservative side of things,” says Schmitt. “If they’re uncomfortable and if they’re not sure, you’re probably going to end up in the pail of drugs because it gives them more time to review safety and effectiveness. Going straight to the application for designation might end up getting you astray on the drug side, and you wouldn’t want that because it costs more and takes more time.

Schmitt adds that there is a limited amount of product information that manufacturers can provide in their request for designation, and that information determines how the product will be classified and the regulatory pathways it must follow. To ensure that their products are properly designated, companies can first file a pre-request for designation with the OCP in order to better understand how certain products will be classified.

While the classification of some drugs and devices remains controversial, the court ruling this year prompted the FDA to take a clearer and more objective stance on regulating certain products as devices. This move, at least for some manufacturers, will reduce the number of hurdles that must be overcome before a medical product can reach the market.


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