According to the FDA (Food and Drug Administration), a medical device is “an instrument apparatus, machine, contrivance, implant, in vitro reagent, or other similar or related articles” that are intended for use in diagnosing and treating diseases and other conditions. If you are considering developing a medical device, there are certain steps you need to take in order for the FDA to approve it.
Medical Device Development Process
There are numerous steps required before your medical device will be approved. If you are wondering how to get your product into the medical device industry, here are five important aspects of the approval process that you need to follow. Click To Tweet
- Research Product Regulations
- Product Creation, Testing, and Development
- Determine Product Classification
- Substantial Equivalence
- Submit Your Pre-Market Approval Application
1) Research Product Regulations
Prior to developing or creating your new medical device, it is a good idea to research various product regulations to see what is required of your device. There are different regulations depending on what type of device you are creating, so make sure to learn everything needed for your particular creation.
2) Product Creation, Testing, and Development
Once you have a medical product in mind, you have to create a prototype and send it through rigorous testing. At this time, your product is not for human use, and you will need to have your product tested through controlled laboratory settings. Your device will go through multiple tests, such as testing for the functionality, bioburden testing, sterility testing, as well as environmental monitoring of the room your device is housed.
Pro Tip: Neglecting proper device testing, like bioburden testing, can result in hefty fines and cause a significant delay in your device entering the market.
3) Determine Product Classification
The pathway to approval for a medical device depends on its risk classification. After your product is developed and tested, you need to check with the FDA to see which of the three regulatory classes it falls in. The regulatory classes are: Class I, Class II, or Class III, based on the level of control necessary to provide reasonable assurance of its safety and effectiveness.
4) 501(k) and Substantial Equivalence
The 501(k) requires proof that your device is substantially equivalent or you will need to go through the premarket approval. A device is considered substantially equivalent if it has the same intended use and the same technological characteristics as another legally marketed device. Compare your device to similar ones, and if it is not equivalent, it will be placed in Class III.
5) Submit Premarket Approval Application
Premarket approval refers to the scientific and regulatory review necessary to evaluate the safety and effectiveness of your device, that devices are not substantially equivalent to other devices, that your device shows scientific evidence that it holds possible benefits to a person’s health, and that the device will significantly help a large number of the intended target population.
The FDA and Medical Product Development
Once you go through these steps of medical device development, it will go through an FDA review. If approved, the FDA is required to publish its decision and all the supporting documentation in the Federal Register and you can begin marketing your device.
Contact us to learn more about medical device development and what it takes to get your product approved.