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FDA Takes Control of Medical Device Approval Process

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The Food and Drug Administration (FDA) is extending its power once again. The agency is reviewing the approval process for moderate-risk medical devices and has proposed 65 changes. The FDA believes the updates are necessary because the procedures have not been reviewed in over 30 years. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, explains that the changes would be phased in.

A trade group, the Advanced Medical Technology Association (Advamed), fears “the FDA proposals may strangle investment in start-up companies and delay products from reaching U.S. patients.” The FDA proposal would include about 90 percent of all medical devices and created concern among industry representatives.

In its essence, the proposed FDA changes would allow for a multitude of new devices, but would require much more data to support their use. The current approval process, created by Congress in 1976, “was intended to speed approval for products considered to have moderate safety risk and to be similar to devices already cleared for U.S. sale. Device makers generally regard the program as a cheaper, faster way to get products on the market.” So, some products currently on the market are lacking data to back the safety and effectiveness of use. The FDA sees this as problematic. Advamed supports the idea that the current process has effectively protected patients over the years, but the FDA strongly believes that the new changes are necessary to keep patients safe.

Consumer groups have criticized the FDA in the past for failing to strongly enforce the medical device industry. Since changes would be phased in, additional data may not be initially required. However, the FDA is taking clear steps towards reigning in control of the $136 billion industry in the future.

2 Comments

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  1. Sue Miller says:
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    This is the best news I have heard in 2 years. My daughter died at 18 years old by having cyanoacrylate used as a medical device which was off label use. The risks stated to us were minimal but it resulted in her death. Had we known the true risks we would never have proceeded with this outpatient procedure and she would still be alive today. The Fda does need to be involved so the risks are stated very clearly and the family is well aware of the consequences.

  2. Greg Webb says:
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    Ms. Miller,

    I am very sorry to hear about your daughter. That is a tragedy that only a parent would understand. I have 2 daughters and cannot imagine losing them. Thank you for reading and responding to the post. I happen to agree with you – the FDA must perform this function, and perform it well.

    Greg Webb