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FDA to Fast Track Programs for Drugs and Medical Devices

The Food and Drug Administration agency is responsible for protecting the public health by ensuring the safety and efficiency of human and veterinary drugs as well as biological and medical devices. The agency has now expedited a range of fast-track approval programs, which means that some devices are approved for marketing before being fully tested. Though this can be a necessity for patients waiting on new drugs and devices to treat health issues, it means that devices are fast-tracked through important safety processes.

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About FDA 510k

FDA created the 510k Premarket Notification program in 1976 with the objective of meeting treatment needs for serious or life-threatening medical conditions faster. Though not considered by the agency as a fast-track option, in truth it does cut down the time it would usually take for a device to reach the market.

FDA 510k submissions incur a cost and take up lots of time and effort, but they can be significant achievements for some companies. More information on the history of FDA 510k can be found on the government site, Acess Data.

How Long Does FDA 510k Approval Take?

Pharmaceutical and medical companies often strive to achieve 510k approval but how long does it take to get a FDA 510k approved? Though the agency sets a goal of 90 days from the submission date to approve an FDA 510k application, the process can take closer to six months. This process, which often leads to unexpected regulatory questions and queries, often leads companies to get help with their planning, to be sure to push the application through as quickly as possible using the third party’s expert knowledge and experience. Companies such as www.fdathirdpartyreview.com can sometimes cut the process down by at least 100 days.

What are the Concerns with Programs Like FDA 510k?

FDA 510k approval has been criticised due to the agency’s disregard of usual safety procedures. A 2014 study found that, on average, 34 of every 100 drugs evaluated were either pulled off the market or issued with black box warnings. Many manufacturers will cover themselves in legal terms by releasing safety warnings about possible side effects, but with many citizens being exposed to drugs or devices before they are deemed dangerous to the public, some cases can be catastrophic and potentially avoidable.

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