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Should the IPO of Medical Device be simplified? The US FDA will substantially Revise the 510 (k) Regulation
【Date：2018.07.17 Source：English Web】Should the IPO of Medical Device be simplified? The US FDA will substantially Revise the 510 (k) Regulation
The 510 (k) regulation currently in use by the FDA was originally established in medical devices amendment in 1976 and was amended in “Safe Medical Devices Act” in 1990. 510 (k) is a application document submitted pre marking to FDA to prove that the device applied for IPO is as safe and effective as the legitimate device which was not affected by pre-marketing approval (PMA). Applicants must compare the device they are applying for to one or more similar devices in the U.S. market and conclude that they are as safe and effective as the one currently available in the U.S. market. In general, the 510 (k) approval process has been of great concern to the outside world. However, there are signs that the FDA may revise the law significantly.
On November 26, 2018, FDA director Scott Gottlieb, PhD, and Jeffrey Shuren, PhD, director of the Center for Device and Radiological Health, announced that FDA was planning to revise the 510 (k) process as it currently was. In a statement about new steps of modernization in the FDA's 510 (k) program, the two noted that the review of the safety and efficacy of medical devices was being advanced with a focus on ensuring that new devices that pass the 510 (k) process was able to meet evolving safety and efficacy standards.
The specific key points are summarized as follows:
1. It is not necessary to compare with similar devices that are old and approved
The statement noted that 20 percent of 510 (k) products approved for application were compared with older products that had been approved for more than 10 years. It obviously does not represent the current rapid development and improvement of medical equipment and the current clinical level. The FDA believes the benefits and risks should be compared with more modernized new devices. To this end, the FDA will promote the use of newer, similar devices for comparison. The FDA will publish on its web site a list of devices that have proved to be substantially equivalent to older devices and have been approved.
2. Eliminate outdated and similar devices that are backward
FDA announced that it would begin phasing out some older 510 (k) approvals to further eliminate the goal of using older, similar devices. It is unclear what does it mean, how it will work or whether the FDA has the legal authority to do so. For example, the FDA notes that it is working to eliminate certain approved devices that may cause safety problems for use in analogies again. While the move makes clear that it is targeting approved 510 (k) devices, the process could also affect other devices that are previously exempted from the 510 (k) process.
The amendment of the new regulations may change the threshold of exemptions for certain device types 510 (k). If the FDA radically changes it, the terms and limitations of the previous 510 (k) exemption may change, which is also one of the many details that must be addressed in the proposal.
According to the statement, the FDA also plans to create an alternative to 510 (k) that would allow sponsors to demonstrate material equivalence by proving that the device meets safety and performance standards for the device type. The FDA said the new approach would assess new devices at contemporary levels, rather than comparing them with outdated ones. "We believe this approach is the future of the 510 (k) program," the FDA said in a statement. FDA's pre-marketing review will be based on looking ahead to modern standards and baselines and will be updated as technology develops. Sometimes, comparisons with older approved devices can actually lead to more advanced technologies being approved, leading to patients losing new treatment options, because innovative technology products are difficult to achieve a high degree of integration or similarity with devices that have been out of date for decades.
Although this approach is described as a new approach in the statement, it sounds a lot like a simplified version of the current 510 (k) path, which allows submitters to rely primarily on baselines that conform to consensus standards for analogue reasoning. The simplified 510 (k) path applies to some device types, but the standard 510 (k) application continues and sub-standard updates are maintained for most device types to ensure that equipment technology remains modernized. The FDA believes the move will make it easier for payers to prove that their products perform better than other devices in the market to help support coverage decisions of the basic medical insurance.
