Securing regulatory approval from the FDA is the sine qua non for any medical device company that seeks to market and sell its products in the USA. There are two approaches by which this approval can be achieved: pre-market approval (PMA), a sometimes lengthy process requiring extensive clinical trials; and the so-called 510(k) approach, where a company’s new product needs to demonstrate equivalence to a predicate device.
In justifying the increase in the CDHR’s budget, the agency has set some performance benchmarks for itself, with the aim of reviewing and deciding on 80% of PMA applications within 180 days of filing and 93% of 510(k) submissions within 90 days. This is good news for companies like CapeRay that need to release their products into the market within a reasonable time period.
“These are tight budget times, and the FDA budget request reflects this reality,” said the FDA Commissioner, Margaret Hamburg. “Our budget increases are targeted at strategic areas that will benefit patients and consumers and overall strengthen our economy. Through the good work of the FDA, Americans will receive life-saving medicines and devices approved as fast as or faster than anywhere in the world, confident in the medical products they rely on daily.”
The FDA’s history is an interesting one, dating back to the late 19th century, in the period after the Civil War. A landmark piece of legislation that launched the agency was the Pure Food and Drug Act of 1906, prohibiting interstate commerce in misbranded and adulterated food and drugs. For over a century the FDA has sought to balance the need to protect the American consumer, on the one hand, with the desire of those same consumers to have access to the latest and most innovative medical technologies.