To market a medical device in the US, manufacturers need to get FDA approval or clearance for their device. Most medical devices require a premarket notification from the FDA or more commonly known as the 510(K) process. After a device’s design is finalized and all testing is complete, then the device is ready to be reviewed by the FDA. The FDA does not typically review the physical product. Instead, the FDA reviews all documents submitted in the application, which is primarily a series of test reports such as verification testing, validation testing, biocompatibility reports, and clinical studies.
The FDA reviews most medical devices under the 510(k) process. What this means is the manufacturer claims to be substantially equivalent to another device, also known as the predicate device. The concept is that the FDA has previously reviewed the predicate device and determined it to be safe and effective. The new device is similar to the predicate device in terms of technology and safety. The argument made in 510(k) is that the data presented establishes the new device and predicate device to be substantially equivalent.
The 510(k) is a series of documents that all discuss the similarities and differences between the new device and the predicate device. Manufacturers will often conduct bench performance testing, pre-clinical and clinical testing on both the new and predicate devices. Then using statistics, evaluate if the devices perform equivalently. All of this testing is sent to the FDA for their review. If the FDA decides the products are substantially equivalent, then the new product can be marketed in the US. The FDA does not technically approve devices that are submitted under the 510(k) process. The FDA only clears these products for marketing.
FDA Substantial Review and the 510(k)
Once the FDA receives payment for the 510(k) and the complete application, they will conduct an administrative review. This process is known as “Refuse to Accept” or RTA and lasts 14 calendar days. The FDA begins the substantial review once the 510(k) is out of the administrative review. The substantial review lasts 60 calendar days. During this time, the FDA may email or call to ask clarifying questions. If they have several questions, the 510(k) may be put on hold, meaning the 60-day clock is paused. The FDA will issue an “Additional Information Request” or AI. The manufacturer will have 180 calendar days to respond to the questions and address deficiencies. Once all the AI questions are answered, the FDA’s clock will start again. After an AI, FDA typically has 30 days to make a decision on if the devices are substantially equivalent.
Contact DeviceLab Today
Most manufacturers estimate the time from submitting the 510(k) to receiving clearance from the FDA to take anywhere from four to six months. DeviceLab has the expertise to develop a strategy for your medical product to ensure regulatory success. Contact DeviceLab today to schedule an appointment or learn more about the FDA regulatory requirements.