Regulatory

The U.S. Food and Drug Administration continues to provide avenues for medical device manufacturers to get their products approved and put on the market faster. Some examples of some agency initiatives are:   New 510(k) pathway- A regulatory pathway that allows medical devices to get their final guidance based upon safety and performance criteria. 21st Century Cures Act - This Act was passed in 2016 and is intended to accelerate the development of medical products and provide new advances for patients. Breakthrough devices Program - Voluntary program to help patients with life-threatening and irreversible conditions.   The FDA is working to lessen the regulatory burden on sponsors. However, devices must go through the regulatory process to be approved for the market. In addition, it can take a long time to get from product concept to product release. Therefore, it is important to understand the FDA submission and product development processes. Product development ... Continue reading →

Businesses involved in the manufacturing of medical devices, relabeling, repacking, or export of Medical devices that are exported to the U.S. are required by FDA law to sign up with FDA and to comply with FDA regulations. Foreign companies operating from off-shore locations or in the US is required to appoint one FDA US agent that assists with the FDA registration of devices and conformity with FDA regulations. Finding a reputable firm and an independent US agent who is knowledgeable with FDA rules and regulations can assist you in registering or renewing your device's registration quickly. This will ensure that your company is recognized by FDA and that you are able to smoothly complete commercial transactions and promotions without having to worry about legal issues caused by US FDA. If you are the manager of a company engaged in the manufacturing and distribution of medical devices for commercial purposes in the US, you would require FDA Device Registration annually. You will ... Continue reading →