In the United States, the FDA’s Center for Devices and Radiological Health (CDRH) is tasked with regulating firms that manufacture, repackage, re-label, and/or import medical devices sold in the United States. Also, the FDA’s CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.
The CDRH is made up of a team of multifaceted professionals who are highly skilled and dedicated. These include scientists, biologists, chemists, etc. They check the medical application devices for their risks and benefits, and once deemed safe and effective, continue to ensure that once in the market devices remain the same.
The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in the United States. The FDA’s oversight of food and drugs started in 1906 when President Theodore Roosevelt signed the Pure Food and Drugs Act.
Right from that very moment, Congress has expanded the FDA’s role in protecting and promoting the development of human and veterinary drugs, biological products, medical devices and radiation-emitting products, human and animal food, and cosmetics.
In the 1960s and 1970s, Congress responded to the public’s desire for extensive oversight over medical devices by passing the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. In 1982, the organizational units at the FDA tasked with regulating medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).
According to the FDA, medical devices are defined as “any instrument, machine, contrivance, and implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, and diagnose disease in man”. Note that examples include thermometers, tools needed by optometrists like the vision screener, or even an advanced robotic surgical device.
FDA also notes that the device does not achieve its purpose by chemical activation or metabolizing within the body. If it does any of these two, then it will be considered and regulated by the FDA as a drug (medicine). Furthermore, the FDA medical devices have been classified into 3 classes as Class I, Class II, and Class III. FDA has classified about 1700 devices so far. The different classes stand for the following
- Class I: They are low-risk devices. There are about 780 such devices.
- Class II: They are medium-moderate risk devices. There are about 800 such medical devices.
- Class III: They are of high risk, generally life supporting and life-sustaining. There are about 120 of them and each requires pre-marketing approval.
Basic FDA Requirements for Medical Supply Companies
The basic regulatory requirements that medical supply companies in the U.S. are expected to comply with are:
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In the United States, medical supply companies (both domestic and foreign) and initial distributors (importers) of medical devices are expected to register their businesses with the FDA. All company registrations will have to be submitted electronically unless a waiver has been granted by FDA.
According to the FDA, all registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers have been mandated to also designate a U.S. Agent. Right from October 1, 2007, company registration now includes a company registration fee.
Medical Device Listing
Medical supply companies in the United States are expected to list their devices with the FDA. Medical supply companies’ mandated to list their devices include:
- Contract manufacturers,
- Contract sterilizers,
- Repackagers and relabelers,
- Specification developers,
- Reprocessors single-use devices,
- Manufacturers of accessories and components sold directly to the end user
- S. manufacturers of “export only” devices
Have it in mind that medical supplies require premarket approvals before their first use in the U.S., either because there is no equivalent device currently on the market, or because the product poses a potentially high risk of illness or injury. Note that premarket approval is a more complex process, with steps including submission of clinical data to support product claims.
In the United States, the FDA sometimes issues an “investigational device exemption,” allowing the product to be placed into a clinical study to garner data on its safety and effectiveness. Even after approval, device makers are required to monitor and report problems to the FDA.
Since the 1990s, the US Office of Inspector General has been monitoring relationships between medical supply companies and health care providers, since the issuance of devices impacts payouts made from federal programs including Medicare and Medicaid. Federal anti-kickback laws prohibit payments, gifts, or other types of remuneration by medical supply companies to health care providers in exchange for patient referrals.
Moreover, Federal law also prohibits a physician who has a financial relationship with a medical supply company (or who has an immediate family member with such a relationship) from making referrals to that company for health services paid for under federal health care programs.
Pre-marketing Notification or 501(K) Program
Note that the aim of this is to demonstrate that a medical device is substantially equivalent to another device that is already legally marketed. Most Class I devices are exempted from this but some need to submit it. All Class II devices that do not need a pre-marketing approval need to submit a 501(k) notification. Each device that has a 501(k) notification needs clearance by the FDA before commercially marketing it.
Quality Systems Regulations
This is the FDA’s current food manufacturing practice. The quality system regulation includes requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. Manufacturing facilities undergo FDA inspections to ensure compliance with the QS requirements.
7. Medical Device Reporting
Simply put, this is a system that the FDA has in place to report any adverse events with respect to a medical device. This adverse event may include or is not limited to a malfunction of the device, which may cause an injury or death.
Medical supply companies, user facilities, and importers of devices are mandated to report any case of an adverse event. This helps to monitor the safety of the device and provide timely interventions and corrections to prevent any hazards.
Medical Device Labelling
This more or less concerns the labels on the device. It states the rules about the instructions for the use, advertising, or promotional material that are printed on the label. For instance, spirometer testing guidelines (A spirometer is a device used to test lung function).
The labeling must not be misleading or false while being marketed. This will lead to misbranding, which is a violation of the Federal food, drug, and cosmetic act. Note that this gives the FDA assurance that the medical device is manufactured consistently with the specifications during the clearance or approval.
Investigational Device Exemption (IDE)
In this program, the FDA expects all unapproved medical devices to be approved for clinical studies on human subjects for safety and efficacy purposes. If the device is of enormous risk, it will need both the approval of the FDA and an institutional review board (IRB). If the device is of non-significant risk, it only needs the approval of the IRB.