FDA approval procedures process guidance

FDA Approval Process

If you are a consumer please call the FDA at 1-888-INFO-FDA (1-888-463-6332) to learn if a particular device, drug, or supplement is FDA approved (please note this site is for a private law firm representing FDA regulated companies and is not the FDA).

The FDA approval process varies depending on the type of product. In general, drugs and medical devices experience a more rigorous approval process than foods or dietary supplements. Not every FDA product will require direct review from the FDA. Thus, some approval procedures will not result in a FDA letter stating the basis for approving the product. Instead, products like cosmetics and Class I medical devices, are subject to review by our firm. This review is formalized in a memo and certificate, which can be used as proof of approval and compliance during a customs check. All products are subject to a label review, which is typically separate from FDA approval pathways.

A summary of each approval process is provided below.

Please contact us with any questions about how the FDA approval process works.

Summary of FDA Approval Procedures
Dietary Supplements (Including Drinks)

Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA). DSHEA requires dietary ingredients be approved in one of three ways. First if the dietary ingredient can be shown in use prior to 1994 then it is “grandfathered-in” and given approval. Otherwise the dietary ingredient must be GRAS (different from conventional food GRAS) or submit a New Dietary Ingredient application.

Labeling

Labeling for all FDA products must be compliant. While unlike the USDA, the FDA does not pre-approve labeling, labeling issues are the leading cause for reclassification or import detention. Reclassification occurs when a product is deemed to be subject to a stricter set of regulations due to labeling. For example, a dietary supplement with medical claims reclassified as a new drug and subject to a new drug application.

Call us today to discuss labeling and our labeling review process.

Drug (Rx and OTC) Approval

The path a drug travels from a lab to a medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease.

For OTC drugs the product must conform exactly to an existing monograph.

For Homeopathic drugs the product must be approved by the HPUS.

For new drugs and generic drugs the product must be approved by the FDA using a new drug application (NDA). This is also the route for amending or combining monographs.

The process is complex and requires careful attention to detail. Call us today to learn more.

Conventional Food

Conventional foods, including ingredients and food contact substances, must be FDA approved before use. This can occur in one of two ways. First through a self-affirming or voluntary GRAS notification (Generally Recognized as Safe). The other is through a Food Additive Petition or Food Contact Notification.

Likewise color additives are also regulated. All colors used in foods must be FDA approved. Colors are either subject to certification or certification exempt. Certified colors must gain approval from the FDA for each batch of color made.

Medical Device Approval

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
Radiation-emitting Electronic Products

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. Radiation emitting devices, like lasers, require a unique accession number.

Please contact us for a complimentary consultation on the device approval route best suit for your device.

Cosmetics

The FDA regulates color additives used in cosmetics and each color must be FDA approved.