FDA Enhances Pre-IPO Review of High-Risk Medical Products

Business Club May 18th The US Government Investigation Agency “Government Accountability Office” (GAO) found that while some high-risk medical devices were approved for sale on the market, US regulatory agencies did not have sufficient safety information, and when medical devices were When problems occur in the sales process, the regulatory authorities will not monitor the recall of medical device manufacturers.

Last year, Johnson & Johnson evacuated 93,000 artificial hip joints from the market, including 37,000 products recalled from the US market. A series of product recalls by the medical device manufacturers headed by Johnson & Johnson has prompted US Congressmen to examine the FDA's approval process in detail. Critics pointed out that the 1976 law of the United States requires all high-risk medical devices to undergo rigorous review, but the FDA has been slow to respond. Many medical devices still receive the minimum standards before they are listed and sold in accordance with the pre-market notice 510(k). Audit.

In the United States, medical device products must go through one of two evaluation processes before they are listed: Premarket Notification 510(k) or Premarket Approval (PMA). Most products are approved through 510(k). The purpose of 510(k) is to prove that the devices listed for listing are as safe and effective as legally listed devices that are not affected by PMA. Applicants must compare the device for listing with one or more similar devices in the current US market, and draw conclusions and support the same conclusions that are safe and effective. In general, the outside world has been very concerned about the 510(k) approval process.

Statistics show that 510(k) approves approximately 3800-4000 products every year. GAO health care director Marcia Crosse pointed out that GAO's preliminary review of the 510(k) found that the FDA's review of some products is not very strict, and there is no routine analysis of medical equipment such as implantable high-risk medical devices. The trend of recalling devices or ensuring that manufacturers have made rectification promises within a specified time frame has increased the risk of unsafe products remaining in the market.

On February 14 this year, the Archives of Internal Medicine reported that 81% of the 113 high-risk medical devices recalled by the FDA from 2005 to 2009 were approved through less stringent methods. Among the recalled medical devices, cardiovascular devices account for one-third of the total.

In response, the US Senate Democrats said that the FDA may need new jurisdictions, including mandatory registration of medical devices and recall powers, so that potential safety issues can be identified more quickly.

It is reported that FDA has conducted an internal audit on 510(k).