Does your product require FDA Approval?
- Provision Consulting Group
- May 13, 2022
- 5 min read
May 13 2022
Most of the products on the market show a mark or ads that they have been approved by the FDA. And many companies say their products are “FDA approved.”
But how can you know for sure what the U.S. Food and Drug Administration has approved?
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
But not all those products undergo premarket approval — that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing the FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.
Here is a guide to how the FDA regulates products — and what the agency does (and doesn’t) approve.
The FDA doesn’t approve facilities.
The FDA approves new human drugs and biological products.
The FDA doesn’t approve compounded drugs.
The FDA uses a risk-based, tiered approach for regulating medical devices for people.
The FDA uses a risk-based approach for human cells and tissues.
The FDA approves color additives used in FDA-regulated products.
The FDA does not approve cosmetics.
The FDA doesn’t approve facilities.
The FDA does not “approve” health care providers, including physician offices, or laboratories. The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.
Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently. The FDA does have authority to inspect regulated facilities to verify that they comply with applicable current good manufacturing practices and other requirements, including an adequately designed and controlled production process.
Unless an exemption applies, owners and operators of domestic or foreign food, drug, and most device facilities must register with the FDA before exporting products to the U.S. Owners and operators of establishments that manufacture blood products or cells, tissues, and cellular and tissue-based products must also register with the agency.
Mammography facilities must be FDA-certified and must display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards for providing quality mammography.
The FDA does not have regulations specific to good manufacturing practices for cosmetics. Cosmetic companies are not required to register their products or facilities with the FDA but may do so voluntarily.
The FDA approves new human drugs and biological products.
New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
Some examples of biological products that require approval are therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma. Manufacturers must also prove that they are able to make the drug or biological product according to federal quality standards.
The FDA does not develop products before approving them. Instead, FDA experts conduct a careful evaluation of the results of laboratory, animal, and human clinical testing done by manufacturers. The FDA does perform "lot release testing" of many biological products, which provides the agency with a real-time system to continuously monitor product quality, through review and testing.
For more information, see:
A directory of approved and unapproved finished drugs on the market.
A complete list of licensed biological products.
The FDA doesn’t approve compounded drugs.
Be aware that compounded drugs are not FDA approved.
This means that the FDA does not conduct premarket review for compounded drugs to evaluate their safety, effectiveness, or quality.
The FDA uses a risk-based, tiered approach for regulating medical devices for people.
The FDA classifies devices according to risk and the level of regulatory controls needed to provide a reasonable assurance of the safety and effectiveness of the devices. (Class I/II/III)
The Class III of highest-risk devices, such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application (PMA).
To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.
Generally, the FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters including masks, and contact lenses) once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class II devices are generally subject to special controls, which may include specific testing or labeling requirements for that device.
Devices that are low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves including sanitary pads) are subject to general controls only, and most are exempt from premarket notification (510(k)) requirements.
The FDA uses a risk-based approach for human cells and tissues.
All human cells and tissues intended for use in people — collectively referred to as human cells, tissues, and cellular and tissue-based products (HCT/Ps) — are regulated to prevent the transmission of infectious disease.
Examples of HCT/Ps include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.
Those HCT/Ps that pose an additional risk because of their processing or use also require FDA approval. The FDA does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung, or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.
The FDA approves color additives used in FDA-regulated products.
This includes those used in food (including animal food), dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency before market entry, and each must be used only in compliance with its approved uses, specifications, and restrictions.
In the approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.
The FDA does not approve cosmetics.
Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval.
There’s one exception: color additives (other than coal-tar hair dyes).
Cosmetics must be safe for their intended use and properly labeled.
Misuse of the FDA’s logo may violate federal law.
The FDA’s logo is for official government use only. The FDA’s logo should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service.
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