Postmarket Regulation About to Be Transformed
Does the name “Sentinel System” mean anything to you? If it doesn’t, you must read the July issue of MD&DI, where we explain a new system that will become a major component of FDA’s postmarket regulatory strategy.
The agency has been faced with a quandary for years. Its mission includes preventing medical products from harming patients. It had chiefly done this by denying approval to devices, drugs, and biologics that, during testing or clinical trials, presented unacceptable health or safety risks.
The problem is, a lot of risks don’t become apparent until after a product is on the market, being used by a much larger population than is feasible to include in premarket testing.
The agency has reacted in part by requiring more data for some 510(k) applications and encouraging larger and longer trials for PMA products, but there is a limit to how far these measures can go. Excessively delaying the introduction of a safe and effective product to the market is a risky proposition in and of itself.
This is why a postmarket surveillance strategy is so crucial. Analyzing reports of adverse events of a product can help the agency and the manufacturer determine risks and hazards that may not have shown up during trials due to sample sizes. This information can then be used to pull the product from the market or stop it from being used on certain kinds of patients.
Until now, there has been no way to get that information comprehensively, or do the analysis quickly. In most cases, the agency is dependent on firms, doctors, and hospitals to file medical device reports when something goes wrong with a device. But writing such a report is often not a priority for the doctor or hospital, and the manufacturer can’t do anything unless it is notified. So postmarket surveillance information is usually incomplete and haphazard.
The Sentinel System could change that. It would tap databases, from CMS to private insurers, that FDA did not previously have access to. It would enable the agency to query these databases all at once, so it could spot troubling trends more quickly than it can now. Medical device manufacturers need to be aware of how their products’ data are going to be used in this system, and how the regulation of their products in the postmarket arena will be changed as a result.
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