There should be no question in any healthcare provider’s mind that medical device development is a lengthy, often very costly process.
Cost estimates for medical devices in the United States in 2011 were between $95 and $150 billion, according to Medscape, which represented somewhere between one-half and three-quarters of the total $200 billion spent on medical devices globally. Chiropractic devices, such as adjusting instruments, make up a part of this overall expenditure.
The ultimate goal, of course, is to get the device approved so that the manufacturer can get a return on investment in developing, manufacturing, and marketing it.
All medical devices, ranging from elastic bandages to pacemakers, must get the U.S. Food and Drug Administration (FDA) seal of approval that they are safe for use on humans.
What is a medical device?
According to the FDA, a medical device must meet three criteria: “Diagnoses, cures, lessens, treats, or prevents disease Affects the function or structure of the body Does not achieve primary intended purposes through chemical action”
Additionally, medical devices are separated into three classes. Class I items, like tongue depressors, are usually exempt from the regulatory process because they pose little risk.
Class II items must meet a stricter standard than Class I items. There are certain standards with regard to performance, patient registries, premarket data, and postmarket surveillance.
Instrument adjusting devices fall into this category. Class III items, such as pacemakers, insulin pumps, or cochlear implants, have the strictest standards to meet, including human trials and premarket approval, because they pose the greatest risk to humans.
Timeline for FDA approval of Class II medical devices
Once a Class II medical device has met Good Manufacturing Practices (GMP) guidelines, the manufacturer can begin to develop and conduct clinical studies, after which the manufacturer will submit a 510(k) premarket notification application to the FDA. In a 510(k) application, the manufacturer must show that the device is substantially similar to
another product already on the market to avoid monopoly by just one manufacturer.
The FDA will then review and, upon successful results, issue a 510(k) clearance letter, allowing the manufacturer to list the device and register the company on the FDA website and also to begin selling the device. This FDA Establishment Registration and Listing must be renewed annually. Authorization does not expire, provided there are no substantive changes, such as to the design or intended use.
While the process may seem very long and complicated, the ultimate goal of assuring healthcare provider and patient safety is worth the time and effort needed to gain FDA approval.