United States Laws for Regulation of Medicines and Medical Devices
In the United States, medicines and medical devices are regulated by the Food and Drug Administration (FDA). The FDA is responsible for ensuring that drugs and medical devices are safe and effective for their intended use, and they must be approved by the FDA before they can be marketed in the US. The Federal Food, Drug, and Cosmetic Act, along with other laws and regulations, govern the FDA's role in regulating drugs and medical devices. Additionally, the Controlled Substances Act regulates the manufacture, importation, possession, use, and distribution of certain drugs, including those that are considered to have a high potential for abuse.
Others important laws which govern regulation of medicine in United States are:
The Federal Food, Drug, and Cosmetic Act (FFDCA): This is the primary law that gives the FDA authority to regulate drugs and other medical products. It sets standards for the safety, efficacy, and labeling of drugs, and it requires that drugs be manufactured, packaged, and labeled in a way that ensures their quality and identity.
The Controlled Substances Act (CSA): This law regulates the manufacture, importation, possession, use, and distribution of certain drugs, including those that are considered to have a high potential for abuse. It classifies drugs into five "schedules" based on their potential for abuse and medicinal value.
The Prescription Drug Marketing Act (PDMA): This law regulates the distribution of prescription drugs to ensure that they are not distributed or sold to individuals or entities that are not authorized to receive them.
The Orphan Drug Act: This law provides incentives for the development of drugs that treat rare diseases, which are referred to as "orphan drugs." It grants tax credits, grants, and other benefits to companies that develop orphan drugs.
The Pediatric Research Equity Act: This law requires that drug companies test their products in children when appropriate and ensures that the FDA has the authority to require such testing.
The Biosimilars Competition and Innovation Act: This law provides a pathway for the approval of biosimilars, which are drugs that are highly similar to already-approved biological products.
The 21st Century Cures Act: This law was passed to speed up the drug development process and make it more efficient, it also includes provisions to improve the development and delivery of medical treatments, including mental health and substance abuse treatment.
For medical devices, in addition to Federal Food, Drug, and Cosmetic Act (FFDCA), following laws are applicable:
The Medical Device Amendments of 1976: These amendments to the FFDCA established the current regulatory framework for medical devices, including the requirement for premarket clearance or approval by the FDA, and the classification of medical devices into different "risk" categories.
The Safe Medical Devices Act of 1990: This law established the Medical Device Reporting (MDR) system, which requires manufacturers and user facilities to report certain types of device-related adverse events to the FDA.
The Food and Drug Administration Modernization Act of 1997: This law, also known as FDAMA, included provisions that aimed to accelerate the review and clearance of certain medical devices, such as those that are substantially equivalent to devices that have already been cleared or approved.
The Medical Device User Fee and Modernization Act of 2002: This law established the Medical Device User Fee program, which allows the FDA to collect fees from device manufacturers to support the review and clearance of medical devices.
The Medical Device Tracking and Notification Act of 2020: This law requires the FDA to establish a medical device tracking system that would allow for the identification of a device's manufacturer, distributor, and retailer, as well as the unique device identifier of a device.
