In America, the FDA’s Center for Devices and Radiological Health, or CDRH, is responsible for regulating the firms that manufacture, repackage, relabel, or import medical devices that are sold in the United States. It also regulates electronic products that emit radiation. These products include lasers, x-rays, ultrasounds, microwaves, and color televisions.
Radiation-emitting Electronic Products
Medical devices are broken down into three classes, Class I, Class II, and Class III. Class I has the least amount of regulatory control and are exempt from having to submit a Pre-market Notification 510(k) for approval. Class II devices; however, require Pre-market Notification 510(k). Class III devices require Pre-market Approval and the approval of two groups.
The regulatory requirements that manufacturers of medical devices that are distributed in the United States must comply with is well outlined by the FDA. Domestic and foreign manufacturers, in addition to the initial importers of the medical device, must have their establishments registered with the FDA. The registrations get submitted electronically unless the FDA grants a waiver. The registration information must be verified every year between October 1st and December 31st. Foreign manufacturers also must designate a United States Agent. Most establishments must pay an establishment registration fee.
Medical Device Listing
Manufacturers must then list their device with the FDA. The information needed to list devices begins with who and where the manufacturers are located. Information about contract manufacturers that distribute the device is needed as well. Contract sterilizers that distribute the device commercially may be needed as well. Any repackagers, relablers, specification developers, and re-manufacturers must be accounted also. There is a lot of information a company must hand over to be able to sell a medical device with the approval of the FDA.
Pre-market Notification 510(k)
A device requiring the submission of a Pre-market Notification 510(k) cannot be sold until you get a letter of substantial equivalence from the FDA that authorized you to do so. The 510(k) that gets submitted must demonstrate that the item is substantially equivalent to one that is in current distribution in the U.S. Simply put, if they find a product that is similar to yours in shape, size, and use, they pass it along a little quicker than something that is totally new.
Medical Device User Fee and Modernization Act of 2002
The Medical Device User Fee and Modernization Act of 2002 authorized the FDA to charge for a medical device Pre-market Notification 510(k) review. A smaller business can pay a smaller fee. By paying a Pre-market review fee, you do not affect the FDA’s final decision when it comes to a submission.
Products that require a Pre-market Approval, or PMA, are generally Class III devices. The high risk devices that pose a threat of illness or injury, or devices that are not equivalent to Class I and Class II predecessors from the 510(k) process are all included. The PMA is directly involved with including the submissions of clinical data to support the claims of the device.
Investigational Device Exemption (IDE)
An Investigational Device Exemption, or IDE, allows the device to get used in clinical studies to collect effectiveness and safety data that is required to back up a PMA application or 501(k) entry to the FDA. The FDA and Institutional Review Board, or IRB, needs this information before beginning the study. If the device is not considered one of significant risk, the IRB is the only approval needed for marketing.
QS and GMP
Quality system regulation includes requirements associated with the methods that are used in the facilities, and controls used for designing, manufacturing, purchasing, packaging, storing, labeling, installing, and servicing of medical devices. Facilities experience FDA inspections meant to assure compliance. Labeling is also mandatory giving descriptive and informational literature to accompany devices.
Medical Device Reporting
In the event that a device causes or contributes to a death or injury, the information must be presented to the FDA under the Medical Device Reporting Program, or MRD program. Certain malfunctions must also be reported as well. The biggest goal of these regulations is to detect and correct any problems quickly and minimize harm to patients.
America has many regulations for medical devices as well as other electronic devices that might pose a risk to users. The FDA keeps these regulations updated and only approves items that have sufficiently proved that they work well without posing too much risk. This helps to create a healthy atmosphere for patients and doctors.