43% of medical device applications fall under Class 2. This moderate-risk category includes devices such as contact lenses, syringes, and catheters. According to the agency, the majority of Class 2 medical devices require a 510(k) application, in which the manufacturer demonstrates a device’s safety and efficacy through substantial equivalence to another currently approved device.
The FDA is required to respond to complete 510(k) submissions within 60 days of receipt. However, this response isn’t a clearance; it’s simply a notice that your application is complete and accepted for review.
The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months.
The average number of days it takes to clear a device via 510(k) varies according to the device category. Anesthesiology devices have the longest average length to approval, averaging 245 days. Toxicology devices are the shortest on-average, at just 163 days.
Please note that an overhaul of the 510(k) pathway is on the immediate horizon. It is unclear at this time whether these changes will impact the approval timeline.
The FDA medical device approval process is just one component of bringing a device to market. The length of time to approval for your device is likely to vary depending on whether you select the traditional or abbreviated 510(k) pathway, and according to your device class. However, if your Class 2 device qualifies for 510(k), it’s wise to anticipate approximately a six-month wait from the time your device application is submitted.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
