High Risk Medical Devices to be Fast-Tracked for Approval?

Patients who suffer from life-threatening illnesses and injuries sometimes have to wait to receive medical treatment. Their doctors may not have access to resources to treat their conditions, or they may have to wait for a more effective medicine to emerge on the market to keep their health conditions under control. The time that people must wait often proves to be expensive and painful; if not lethal. To minimize the number of patients who must wait for care, the FDA now offers medical manufacturers an expedited review process to bring vital healthcare products to the market sooner.

The expedited review process does not minimize the need for safety and effectiveness. As the product is prepared for public use, the FDA requires that several criteria be met. First, leaders from the FDA will work with manufacturing executives to gather preliminary data and review reports to ensure that the product can indeed be made available for use. During this earliest stage, adjustments can be made before the medical item obtains permission for manufacturing.

Next, the FDA will ensure that managers from this agency, as well as executives from healthcare manufacturers, review cross-disciplinary reports of the product to ensure its full safety and viability. Case managers from the FDA will review applicants’ data and development plans, and act as liaisons between the product’s corporate sponsors and senior reviewers within the FDA.

The last phase of bringing the product to market involves a priority review process. This process entails presenting manufacturers with pre-market data,  post-market data, as well as answering manufacturers’ concerns and other agencies’ requests to speed up the timeframe by which the device can be commercialized and made fully available for sale.

This expedited process, however, is only available for medical devices and products that are deemed critical to patient care and for which no substitute can be found. People who are suffering from serious diseases and illnesses that prove to be life-threatening can benefit the most from this FDA expedition. They can get the care they need, and look forward to recovering sooner.

Likewise, the process can be applied to devices and products that are identified to feature breakthrough technology. As the medical field continues to embrace and utilize technological inventions, patients who otherwise would suffer disabling health conditions, or even die from their illnesses, can benefit when breakthrough inventions are made available for their doctors’ immediate use. Medical manufacturers can find out more if their products qualify for this EAP process by contacting the FDA or by reading information online.

Source:
http://www.massdevice.com/blogs/massdevice/fda-offers-expedited-us-market-pathway-some-high-risk-devices