Many industries have to submit to the FDA's regulatory regime. If you're not sure whether your business might be one of them, you may want to speak with an FDA regulatory consultant. Typically, firms in these 6 industries are the most likely ones to have to address FDA regulatory concerns.
The D in FDA standards for drugs, after all. However, the FDA's power extends well beyond the medicine cabinet. The FDA also regulates most types of medical devices, including things ranging from needles to artificial hearts.
Similarly, the FDA regulatory purview extends to biologics. These are medical products that involve some biological components. For example, most types of biological sampling systems, such as test kits, are FDA-regulated. Even if the process isn't especially invasive, such as a test where someone spits in a cup, there's a good chance the FDA governs its use.
Okay, this is the F in FDA. The FDA has domain over most types of food not governed by the USDA. Generally, the USDA deals with meats, poultry, and eggs. You can expect everything else to be FDA-regulated, even if it's something simple and hard to mess up, such as crackers.
While public water is the domain of the EPA, bottled water falls under the FDA. Similarly, while nutritional supplements sound medical in nature, they're considered food items. Either way, the FDA regulates them. Lastly, infant formula is also an FDA issue.
This one often surprises folks when they ask for FDA regulatory consulting advice. However, the inherently medical nature of the issues tied to measurable levels of radiation exposure makes these devices the FDA's problem. You will find some oddballs on this list, including microwave ovens and sunlamps. Less surprising items include radiation-emitting medical devices. Likewise, most devices that use lasers are FDA-regulated.
Many of the materials in cosmetic products are similar to the ones in foods. Likewise, the application of cosmetics to the human body entails medical risks. Consequently, the FDA exerts regulatory power over nearly all cosmetics. This covers everything from perfumes to nail polishes.
Generally, tobacco products are seen as consumer goods with potential medical issues. Once more, that makes all consumer tobacco products the FDA's concern. Notably, this extends to roll-your-own tobacco products.
Foods and medicines for animals are usually under the FDA's regulatory preview. This includes livestock feeds and pet foods. Even veterinary devices are regulated.
For more information, contact a company like Compliance Insight.