Most customers think about the Food and Drug Administration (FDA) as something that only handles the approval and regulation of drugs, however, they are responsible for the examination and approval of the medical device, too. Similar to its regulation of drugs, the FDA’s approval process for medical devices caters to and ensures the safety of all patients that are in want to purchase Medical Supplies in New Jersey, all while keeping the efficacy of a product’s use in mind.
The FDA then completes its review and approval of a medical device through the Center for Devices and Radiological Health (CDRH) and, dependent upon the risk, use, and complexity of the devices being examined, assigns it to its appropriate category, called “Classes,” arranged according to risk.
Examples:
Class 1 is low risk, including facemasks and other things that aren’t as internally invasive. Class 2 devices are medium risk, including items such as contact lenses or heart rate monitors. Class 3 are high-risk items, which may include hip replacements, pacemakers, and the like.
Once approved, the FDA conducts post-market safety monitoring of the devices through the different providers of pharmaceutical services to ensure continued safety and efficacy.
Prescription Center Pharmacy is a trusted and dedicated provider of top-quality Pharmaceutical Services in New Jersey. Our services were designed and curated to cater to any of our clients’ specific medical needs.
Visit our Compounding Pharmacy in Union City, New Jersey today to know more about what we can do for you!
