JASMA

What counts as a “health care product” in the U.S.?

“Health care products” is a big tent. In practice, the rules depend on the product category and the claims it makes.
Many products fall under the Food and Drug Administration (FDA), but advertising claims often fall under the Federal Trade Commission (FTC).
Laboratory testing quality involves the Centers for Medicare & Medicaid Services (CMS) under CLIA. And sometimes the most important question is:
“Which rulebook am I in today?”

Common categories you’ll see regulated

• Drugs (prescription and over-the-counter): pills, inhalers, creams, injectables, etc.
• Biologics: vaccines, blood products, many cell and gene therapies, monoclonal antibodies, and more.
• Medical devices: from tongue depressors to implantable heart valves and software used for diagnosis.
• Diagnostics: many in vitro diagnostic (IVD) tests are regulated like devices; labs also must meet CLIA standards.
• Combination products: products that combine drug + device, biologic + device, or other hybrids.
• Dietary supplements: vitamins, minerals, herbalsregulated differently than drugs.
• Cosmetics: makeup, skin care, certain personal care productsrecently modernized rules add new responsibilities.

The same substance can be regulated differently depending on intent and claims. A cream that “moisturizes” may be a cosmetic,
but if it claims to “treat eczema,” it starts looking like a drug. Regulation often follows the promise.

The main regulators (and what they focus on)

FDA: safety, effectiveness, quality, and labeling (for many product types)

The FDA regulates many medical products under different centerslike the Center for Drug Evaluation and Research (CDER) for drugs,
the Center for Devices and Radiological Health (CDRH) for devices, and the Center for Biologics Evaluation and Research (CBER) for biologics.
The agency’s job includes evaluating premarket submissions (when required), setting quality manufacturing expectations, monitoring postmarket safety,
and taking enforcement action when products are unsafe, adulterated, or misleadingly labeled.

FTC: advertising truthfulness and claim substantiation

The FTC is the “prove it” agency for advertising. If an ad says a supplement “burns fat” or a device “reverses neuropathy,”
the FTC expects the advertiser to have appropriate supportoften described as “competent and reliable scientific evidence,” with rigor matching the claim.
The FTC’s health products guidance emphasizes that strong health benefit claims typically need strong evidence (and vague vibes don’t count as science).

CMS (CLIA): laboratory quality standards

Many clinical labs must be certified under the Clinical Laboratory Improvement Amendments (CLIA), overseen by CMS.
CLIA focuses on lab testing quality systems (how the lab runs tests), not necessarily whether a specific test has FDA clearance or approval.
That splitlab quality vs. product regulationmatters a lot in diagnostics.

Also worth noting: states often regulate professional practice and licensing (like pharmacy boards for compounding),
and other federal agencies may be involved depending on product specifics. But for most people, the FDA–FTC–CMS triangle is the core map.

How drugs are regulated: from idea to pharmacy shelf

For drugs, the U.S. system generally expects evidence of safety and effectiveness for intended uses, plus reliable manufacturing quality.
That evidence is reviewed through formal application pathways.

New drugs: NDA (New Drug Application)

A sponsor typically investigates a drug in studies and clinical trials and then submits a New Drug Application (NDA).
FDA review considers whether the drug works for the proposed use, whether risks are acceptable, whether labeling is appropriate,
and whether manufacturing can consistently produce quality product.

Generics: ANDA (Abbreviated New Drug Application)

Generic drugs generally go through an Abbreviated New Drug Application (ANDA), which relies on showing the generic performs like the brand
(for example, bioequivalence), rather than re-running the full original clinical effectiveness program.

OTC drugs: two common routes

Over-the-counter (OTC) drugs may come to market through an NDA (including “switches” from prescription to OTC)
or through the OTC monograph system, which functions like a rulebook for certain OTC ingredients and conditions.
Modern reforms shifted much of the monograph process from rulemaking to administrative orders, aiming to make updates more efficient.

After approval: the safety story continues

Approval isn’t the end of regulationit’s the beginning of real-world monitoring. FDA’s MedWatch program provides a gateway for reporting
serious issues and sharing safety information. Postmarket data collection helps regulators detect rare events, manufacturing issues,
or misleading promotion that didn’t show up during premarket studies.

Biologics and biosimilars: living systems, stricter controls

Biologics are often made in living systems, which makes manufacturing consistency and quality controls especially important.
Many biologics are reviewed under a Biologics License Application (BLA), including vaccines and certain advanced therapies.

Biosimilars: the 351(k) pathway

Biosimilars (and interchangeable biosimilars) generally follow an abbreviated pathway under section 351(k) of the Public Health Service Act.
The focus is on demonstrating the product is highly similar to a reference biologic, with no clinically meaningful differences in safety, purity, and potency,
supported by a “totality of evidence” approach that includes analytical and clinical components.

Translation: for biologics, “close enough” has to be proven with sophisticated sciencebecause you can’t simply copy-and-paste a living manufacturing process.

Medical devices: risk-based pathways (and lots of acronyms)

Medical device regulation is generally risk-based. Devices can range from low-risk products (like some bandages) to high-risk implanted devices.
The pathway to market depends on classification and risk, and whether there’s an existing “predicate” device to compare against.

510(k): showing substantial equivalence

A common route for many moderate-risk devices is the 510(k) premarket notification, where a manufacturer demonstrates the device is
“substantially equivalent” to a legally marketed predicate device (meaning similar intended use and technological characteristics, with no new safety/effectiveness questions).

De Novo: for novel, lower-to-moderate risk devices without a predicate

If there’s no predicate device but the risk profile can be managed through general and special controls, a De Novo classification request
can provide a pathway to market and establish a new device type that future devices might reference.

PMA: higher-risk devices

For many higher-risk devices, Premarket Approval (PMA) is the most stringent route, typically requiring stronger clinical evidence and deeper review.

Quality systems: making devices the same way every time

Device makers must also meet quality system expectations. FDA finalized a Quality Management System Regulation (QMSR) rule aligning device quality requirements
more closely with ISO 13485, with an effective date set for early 2026giving manufacturers a transition period to prepare for updated compliance expectations.

Diagnostics and lab testing: FDA oversight meets CLIA reality

Diagnostics can be regulated in two overlapping ways: the test kit or IVD product itself (often within FDA’s device framework),
and the laboratory performing the testing (under CLIA, overseen by CMS). Think of it like regulating both the recipe and the kitchen.

CLIA: quality standards for labs

CLIA applies to facilities that test human specimens for health assessment or disease diagnosis, prevention, or treatment.
Labs generally need the appropriate CLIA certificate based on test complexity and must meet quality standards for how they conduct testing.

LDTs: a moving target in recent years

Laboratory Developed Tests (LDTs) have been a long-running policy debate. In 2024, FDA issued a rule amending aspects of how certain diagnostic products are defined,
and in 2025 a federal court vacated that rule; FDA later issued a final rule in 2025 reverting regulatory text to the pre-2024 version.
This back-and-forth matters because it influences whether and how some tests may face FDA premarket expectations versus primarily operating under CLIA oversight.

For labs and diagnostic developers, the key lesson is practical: regulatory expectations can shift, so compliance planning needs a “version control” mindsetlike software,
but with more lab coats.

Combination products: when categories collide

Combination products blend regulated typeslike a drug + device (think drug-eluting stents) or a biologic + device (some delivery systems).
FDA defines combination products in regulation and coordinates oversight because these products can trigger multiple sets of requirements.

Why combo products get complicated fast

• Multiple rulebooks: drug cGMP expectations, device quality systems, and labeling rules can all apply.
• Primary mode of action: regulators determine the “lead” center based on what drives the main therapeutic effect.
• Inspections: FDA inspection approaches address the blend of quality requirements for the product’s constituent parts.

If you’re building a combination product, you don’t just need a good productyou need a good translator to speak both “device” and “drug” fluently.

Dietary supplements: regulated, but not like drugs

Dietary supplements live in a unique regulatory lane. Under the Dietary Supplement Health and Education Act (DSHEA), supplements are regulated more like a category of food
than as drugs. In general, FDA does not “approve” dietary supplements before they are marketed.

So what does FDA do for supplements?

• Postmarket oversight: FDA can act against adulterated or misbranded supplements.
• New Dietary Ingredients (NDIs): if a supplement contains certain “new dietary ingredients,” companies may need to notify FDA with information supporting
  why the ingredient is reasonably expected to be safe under labeled conditions of use.
• Label rules and claim boundaries: “structure/function” claims (like “supports bone health”) are treated differently than disease claims
  (like “treats osteoporosis”), and the line matters a lot.

FTC and supplement advertising: show your work

Where FDA focuses heavily on labeling and product oversight, the FTC focuses strongly on advertising claims. The FTC’s guidance explains that health-related benefit claims
should be supported by competent and reliable scientific evidence, and the strength of evidence should match the strength of the claim.
In plain terms: if your headline sounds like a medical breakthrough, your evidence better look like one.

This is why you’ll often see supplement marketing lean on softer language (“supports,” “helps maintain,” “promotes”), while disease treatment claims can trigger enforcement risk.

Cosmetics: modern rules, new responsibilities

Cosmetics regulation has evolved significantly with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
MoCRA adds new requirements and authorities that affect manufacturers, processors, and brandsespecially around registration, listing, and safety-related expectations,
while also providing exemptions for certain small businesses (with important limitations).

What MoCRA changes for many cosmetic businesses

• Facility registration and periodic renewal requirements for many manufacturers and processors.
• Product listing with FDA for many cosmetic products.
• More structured oversight around safety, adverse event reporting, and enforcement tools.

The big idea: cosmetics are no longer the regulatory “wild west.” MoCRA pushes the sector toward stronger accountabilitywithout turning lipstick into a prescription drug.

Marketing, labeling, and claims: the fastest way to “regulate yourself” into trouble

You can have a perfectly manufactured product and still get in hot water if your claims run ahead of your evidence.
In the U.S., oversight depends on where the claim appears and what product type it is.

Prescription drug promotion: FDA’s OPDP

For prescription drug promotion, FDA’s Office of Prescription Drug Promotion (OPDP) aims to ensure promotion is truthful, balanced, and accurately communicated.
OPDP also runs educational efforts like the Bad Ad program to help health professionals recognize and report misleading prescription drug promotion.

Advertising across health products: FTC’s playbook

The FTC’s health products guidance lays out expectations for substantiation and emphasizes that ads must not be deceptive.
It also highlights that the quality of evidence mattersespecially for claims about treating, preventing, or reducing the risk of disease.

A quick “claim reality check”

• Low-risk claim: “Supports daily wellness.” (Still needs to be truthful, but it’s vague.)
• Medium-risk claim: “Helps maintain healthy blood sugar already in the normal range.” (Now you’re implying a physiological effect.)
• High-risk claim: “Reverses diabetes.” (Congratulations, you just invited the regulators to dinner.)

The safest strategy is boring in the best way: align claims with product category, keep evidence on file, and treat every marketing sentence like it might be read aloud in a courtroom.

Postmarket surveillance, reporting, and enforcement: when the real world weighs in

Regulation doesn’t stop at launch. Real-world use can reveal rare adverse events, unexpected interactions, quality defects, or misuse.
The U.S. system uses reporting and surveillance tools to detect and respond to these issues.

MedWatch: a front door for reporting problems

FDA’s MedWatch program supports reporting serious problems with human medical products and shares clinically important safety information.
It’s part of the broader postmarket approach to protecting patients after products reach wide use.

Medical device reporting and databases

FDA receives a very large volume of medical device reports each year as part of Medical Device Reporting (MDR), which supports postmarket surveillance and benefit-risk assessment.
FDA also maintains public-facing resources such as the MAUDE database for device adverse event reports.

Inspections and quality enforcement

Inspectionswhether for drug cGMP compliance, device quality systems, or combination product requirementsare where documentation meets reality.
Regulators look for evidence that you can make the same product, the same way, every time, and that you investigate problems instead of “hoping them away.”

Recalls, warning letters, import alerts, and other enforcement actions can follow when risks are significant. The goal isn’t to punish innovationit’s to keep innovation from becoming a headline nobody wants.

Practical roadmap: how to navigate regulation without losing your mind

Whether you’re a product developer, clinician, business owner, or a curious consumer, a few practical principles help make the system feel less mysterious.

For companies and product teams

1. Define the product category early: drug, device, biologic, supplement, cosmetic, or combination product.
2. Align claims with the category: claims determine regulatory risk faster than packaging design ever will.
3. Plan your evidence strategy: match evidence strength to claim strength (and assume someone will ask to see it).
4. Build quality systems before scale: manufacturing quality isn’t a “Phase 2” activity; it’s the foundation.
5. Design for postmarket reality: adverse event reporting, complaint handling, and CAPA aren’t optional extras.

For consumers (and anyone allergic to hype)

• Separate “approved/cleared” from “marketed”: some categories require premarket review, others don’t.
• Be skeptical of disease cure claims: especially for supplements and “one weird trick” products.
• Use official reporting channels: serious product problems can be reported through FDA’s MedWatch system.

Regulation can feel frustratingly slowuntil you remember what it’s protecting: people with real bodies, not beta testers.
The best systems let innovation happen and reduce the odds that the innovation accidentally becomes a cautionary tale.

Real-World Experiences: What “Regulating Health Care Products” Looks Like Up Close

Because regulation can sound abstract on paper, it helps to translate it into what people actually experience. The stories below are not “one specific company”
or “one specific patient,” but common patterns reported across the health care product ecosystemregulatory realities that repeat often enough to feel like folklore.

1) The startup that learned “claims” are a product feature

A small team launches a wearable that tracks a biomarker. Their first landing page says, “Detects early disease.” Investors love it. Regulators won’t.
The team discovers that the sentence is effectively a regulatory decision: diagnostic claims can push a product into a higher-risk category with stronger evidence expectations.
They revise the language to focus on wellness and tracking, then build a longer-term clinical validation plan for future medical claims.
The experience feels like a marketing downgradeuntil they realize it’s a strategy upgrade: the product becomes compliant now, and the evidence roadmap becomes clearer.

2) The device team that got stuck on the predicate puzzle

Another common experience: a device developer assumes the 510(k) pathway will be straightforwardthen discovers that “substantial equivalence” is not a vibe,
it’s a structured comparison. Finding the right predicate can take time, and small differences (new materials, new algorithms, new intended use language) can create
“new questions of safety and effectiveness.” Teams often learn to treat regulatory strategy like product design: you iterate, document decisions, and test assumptions early.
The teams that do best usually bring regulatory experts in before finalizing features, not after.

3) The supplement brand that underestimated the FTC’s “prove it” mindset

Many supplement brands begin with the belief that “everyone says this kind of thing.” Then a competitor challenges a claim, an ad platform requests substantiation,
or regulators scrutinize results. The brand learns that “clinical-grade” language can be risky if the evidence doesn’t match. They tighten claims (“supports,” “helps maintain”),
standardize their ingredient specs, and invest in higher-quality studies. The surprising outcome: fewer exaggerated promises can actually increase trust and reduce returns,
because customers feel less misled. Compliance becomes a growth strategy instead of a handbrake.

4) The lab director living in the CLIA–FDA overlap

In diagnostics, lab leaders often describe regulation as a two-layer cake: CLIA governs lab quality systems, while FDA oversight may apply to IVD products depending on circumstances.
Over the past few years, the LDT policy debate has added uncertainty, with legal and regulatory developments changing the landscape.
The lived experience is constant planning: documenting validation, strengthening quality practices, watching federal updates, and making sure clinical teams understand what a test can
and cannot conclude. The best-run labs treat compliance as continuous operations, not a one-time projectbecause patients rely on accurate results, not regulatory optimism.

5) The “inspection week” nobody forgets

Ask regulated manufacturers about their most vivid memory and many will mention inspection week: conference rooms become war rooms, binders multiply like rabbits,
and everyone suddenly cares deeply about the exact wording of a procedure written two years ago. The most successful teams aren’t the ones who hide problemsthey’re the ones who
show they detect issues, investigate root causes, and fix systems so the same problem doesn’t reappear. In other words, regulators aren’t expecting perfection;
they’re expecting control, accountability, and evidence that quality is real.

These experiences point to a simple truth: regulation isn’t separate from product development. It’s woven into design decisions, evidence planning, manufacturing discipline,
and marketing honesty. When teams treat regulation like an afterthought, it becomes a crisis. When they treat it like part of the craft, it becomes a competitive advantage.