FDA Explains Previous Flaws In Product Approval, 510(k) Process

The FDA may change the process for product approval in the near future

For many years, the FDA had approved some devices that were potentially harmful. Because of that, they have issued massive recalls as experts believe these devices did not undergo the standard procedures.

The medical industry has noticed the most significant potential problem, as many devices found themselves in the health industry. Among these medical devices, 31 percent are cardiovascular devices and nearly 70 percent of of those were approved an expedited 510(k) process.

As a result, many products that were passed via the 510(k) process and originally believed to be high-risk to be recalled, have been deemed as safe.

Recently, the FDA proposed to shorten the expedited process of the products vying for approval to help limit the chance of a similar issue occurring in the future. They will give priority to those products that are revolutionizing instead of those innovations or remodeled products.

If the new suggestions land, each product may have a specified manager which would allow important issues to be discussed and remedied earlier. Additionally, the products may be eligible to undergo various clinical trials as well.

Experts explain these new methods may be beneficial if government officials use best judgement when determine which products are revolutionary.