FDA Changing Medical Device Approval Process

Recently, the FDA issued proposed changes to the approval processes for medical devices. The changes come on the heels of a September 2009 report in which the FDA accused some of its own top regulators of caving in to political pressure when approving some products.

In July, the advocacy group Public Citizen released a report in the journal PLoS Medicine detailing deficiencies in the approval methods for medical devices. In the study, the group outlines the two basic ways that medical devices are approved. “Premarket approval,” or PMA, is reserved for devices that are “novel” and those that have a higher risk associated with them. The report notes, however, that the majority of products proceed down a different path to approval.

Changes to 510(k) Approval Process

In “premarket notification,” often referred to as 510(k) approval, the manufacturer only has to show the FDA that its device is “substantially equivalent” to one currently on the market. This method of approval is the focus of the changes proposed by the FDA. The FDA notes that the goal of these changes is to better define the process and rules, not to prevent manufacturers from using the 510(k) approval process.

One proposed change would require device manufacturers to provide clinical data showing that their device is similar to one already on the market, taking longer and costing more for the companies to obtain approval. This change would affect Class II devices, which are those that propose a “moderate” risk to consumers.
The FDA also wants rules that clarify its authority to rescind approval, which The Wall Street Journal notes has only been done 100 times since the rules were enacted 30 years ago.

In a $200 billion industry, many medical device companies are questioning the changes. A Dow Jones report cites the concern among many manufacturers that the changes could be “potentially disruptive” to their business. The 501(k) approval process is the preferred method for device manufacturers to get their products on the market because it is generally faster and less expensive. While not opposed to some changes or clarification in the rules, manufacturers would prefer the FDA to take a more limited role in the approval process.

Although the length of time it takes to get some products out will be longer in some cases, the FDA is hoping the process changes will lead to safer medical devices implanted in patients and used by doctors and hospitals.

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FDA proposing changes to the medical-device approval process, Star Tribune