Navigating Drug-Device Product Regulations
In the world of medical device regulations, the rules governing drug-device combination products are often considered the most difficult to interpret.
Although these kinds of products traditionally follow the regulatory pathway for pharmaceuticals, regulators still expect them to meet FDA regulations for medical devices. This poses a challenge for companies that are only familiar with pharmaceutical regulations and have little to no experience with medical device regulations.
This is where experienced medical device development experts come in handy.
Meet medical device regulations with a product development firm
Partnering with a product development firm specializing in medical device R&D and regulations can help develop products in a way that will satisfy regulators. These firms help to navigate and manage FDA regulations related to human factors, usability, and device risk assessment.
Setting yourself up for success with the 510(k) pathway
When developing a medical device, companies must decide if they are going to follow the pre-market approval (PMA) pathway or the 510(k) clearance pathway with the FDA. The key distinction between these two regulatory routes is that a PMA applies only to an entirely novel product, meaning there is no comparable product already on the market.
If you’re developing a product that is similar in some way to a product that’s already on the market, you’ll likely choose to submit your product as a 510(k) package with the FDA. And a crucial step within the 510(k) pathway is identifying a predicate device.
Related Article: 510(k) Submission: Clearance & Selecting a Predicate Device
Selecting A Predicate Device
A predicate device is a legally-marketed device to which you are drawing equivalence with your own product. Once you’ve selected a predicate, your product must meet or exceed performance and safety standards for that device.
To set yourself up for success, you need to pick your predicate device wisely. After all, in selecting a predicate device, you’re also setting goalposts for the safety and performance criteria of your own product.
It’s also critical that you get a grasp on what experiments and tests you should run (and what data you should gather) to appropriately justify your choice of the predicate device to the FDA