Securing FDA approval not quick, easy or inexpensive

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Getting a medical device approved by the Food and Drug Administration can take years and cost hundreds of thousands of dollars.
And the more complex the device, the more cumbersome the process, which varies depending on what the device is used for, said Mike Fisher, professor at Regis University.
Products must be proven safe and effective before they go on the market, according to the FDA Web site.
“At the heart of all FDA’s medical product evaluation decisions is a judgment about whether a new product’s benefits to users will outweigh its risks,” the Web site says. “No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great — especially for products used to treat serious, life threatening conditions.”
Fisher, who owned a medical device company for 20 years, is familiar with the steps required by the FDA. The administration rates products based on how invasive they are to patients — the more invasive, the more scrutiny.
Still, the time to market depends on the product, the success of the trials and the paperwork already completed.
“If they can get equivalency with similar device, are extremely lucky with the trials and have completed much of the paperwork, then it could be a few months,” Fisher said. “But … it could stretch to years, particularly for a new device. It’s an arduous process.”
The FDA established three regulatory classes for medical devices in 1976.
Class I devices represent minimal potential for harm and are simpler in design. Examples are enema kits and elastic bandages — about 47 percent of medical devices fall under this category. The FDA exempts 95 percent of these kinds of products from the regulatory process.
Class II devices represent items such as powered wheelchairs and some pregnancy test kits — about 43 percent of the market.
Class III devices, ones that sustain or support life, are implanted or present potential unreasonable risk of illness or injuries. Devices in this category include pacemakers and breast implants. Only 10 percent of medical devices are Class III devices, and they receive the most scrutiny.
These devices are subject to extensive review, with applications that are complex, multi-volume submissions supported by clinical data.
After clinical trials are completed, the FDA reviews the results of laboratory, animal or human clinical testing to determine if the products are safe and effective. The pre-market review is done for new drugs and biologics, complex medical devices, food additives, infant formulas and animal drugs.
“A primary safeguard in the way the FDA regulates medical devices is the requirement that manufacturers must submit to FDA a pre-market approval application if they wish to market any new products that contain new materials or differ in design from products already on the market,” according to FDA rules. “A PMA submission must provide valid scientific evidence collected from human clinical trials showing the device is safe and effective for its intended use.”
The FDA must review PMA applications within 180 days, but the process can take longer. In 2004, the average review time was 228 days and the average time from submission to decision was 436 days, according to Latham and Watkins, an international patent law firm.
For a small company competing with large pharmaceutical concerns, the stakes for each new product are very high, Fisher said.
“A small company with a good product can take a big piece of the market share,” he said. “That means the competition — Johnson & Johnson, Boston Scientific or Medtronic — is going to pay attention The pressure is on a smaller company to do what they can to keep their devices as the predominant therapy in the marketplace. That’s where quick FDA approval comes in.”
Amy.Gillentine@csbj.com