Known for regulating food and medication, the Food and Drug Administration (FDA) also evaluates medical devices for safety. Manufacturers must notify the FDA 90 days before they intend to market a new device or an existing device they have modified. Unfortunately, a device manufacturer’s investment in research, development and raw materials can end in lost profits if approval takes too long. Seventy-five percent of applications are rejected the first time they are submitted. This flood of errors and second submissions bogs the system down. This is where outsourcing routine tasks to third parties can help. Their special familiarity with FDA requirements makes them vital.
Outsourcing Speeds Approvals
Medical manufacturers need to get their devices on the market quickly. How long does it take to get a FDA 510K approved? FDA reviews average 172 days from submission to final approval, but much of that time is spent fixing problems. In 1997, the FDA created third-party programs training individuals and companies to review and evaluate medical devices. This might be the first instance of a middleman saving time instead of adding time and unnecessary steps to otherwise straightforward tasks.
Medical device manufacturers engage third-party reviewers like TPRG to shorten that approval time. Third-party reviewers can generate approvals faster because they know which documents can trigger rejection, how pages should be formatted, and in what order they should appear.
Unlike manufacturers, who must balance device releases with daily necessities, third parties like fdathirdpartyreview can devote their full attention to moving applications as quickly as possible. Third-party reviewers can sometimes cut first submission approval time down to 60 days.
Experts Guide Manufacturers Through the Confusion
Besides protecting manufacturers’ profits, private reviewers can also save manufacturers money because using the review service can eliminate FDA user fees. To start, they find out if a device requires a 510K review, saving the manufacturer from completing an unnecessary procedure. If a device qualifies, the manufacturer submits the 510K to the third party first. The third party then goes over the submitted information and guides the manufacturer through each step on the way to approval. Saving time and saving money, third party reviewers have become a valued part of the FDA’s approval system. A third-party review company can be a medical device company’s partner in success.