“The FDA requires a comparative analysis to devices already on the market,” says Daniel Kamm, principal engineer for Kamm & Associates, an FDA consulting firm for device manufacturers. It takes roughly three to six months before approval is granted, and it’s up to the manufacturer “to show through test reports that it’s at least as good as what’s on the market,” says Kamm.
Class III devices are defined by the FDA as those that usually sustain or support life, are implanted or present potential unreasonable risk of illness or injury. Examples of Class III devices include pacemakers and breast implants. According to the FDA, 10% of medical devices fall under this category.
These devices require clinical trials for approval. “It can take years and hundreds of thousands of dollars to be approved,” Kamm says. “It can be a very expensive and time-consuming process. The device is put through the paces to demonstrate what its effect is on patients to see if it’s safe and effective.”
When trying to bring a device to market, a manufacturer first needs to determine the class to which the device belongs. The FDA provides two ways to discover how to classify the device and whether any exemptions will apply. It offers a database on its website (fda.gov) where you can search the device name. Or, if you know the panel or medical specialty to which a device belongs, you can go to the panel’s web page and identify the device and the corresponding regulations. (The FDA has classifications for approximately 1,700 different generic types of devices and has organized them into 16 medical specialties called “panels.”)
Kamm notes the Division of Industry and Consumer Education (DICE) is a helpful resource for anyone looking to bring a medical device to the marketplace. “They will help you work through what you need to find your way through the regulatory path,” he says. The webpage for DICE is at fda.gov, under the Medical Devices heading.
Prescription Drug Approvals
The goal of the FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in the U.S. are safe and effective. It does not test drugs—the manufacturer of the drug administers clinical trials—although its Office of Testing and Research does limited research in the areas of drug quality, safety and effectiveness.
The center oversees prescription and nonprescription (over-the-counter) drugs. Companies that apply to launch a new drug in the U.S. are responsible for testing the drug in accordance with the FDA’s guidelines and supplying evidence that the drug is safe and effective. The process of getting FDA approval for a new drug can take as little as one year or up to a decade, according to Michael Anisfeld, president of Globepharm, a consulting firm for healthcare manufacturers.
The FDA has a two-tier system for new drug review. The standard review is for a drug that offers, at most, only minor improvement over existing marketed therapies, and the goal is to get it reviewed within 10 months. Priority designation is applied to drugs that offer major advances in treatment or provide a treatment where none existed previously. The goal for completing a Priority Review is six months. Other approaches, including Fast Track, Breakthrough Therapy and Accelerated Approval, were designed to speed the approval of therapeutically important drugs.