Getting FDA Approval
Medical Device Regulations
- Applying FDA medical device regulations
- Medical device verification & validation testing
- Navigating drug-device product regulations
- Setting yourself up for success with the 510(k) pathway
- Organizing your FDA submission package
- Optimizing your product development plan
- Bridge medical device R&D and regulatory activities with Goddard
Applying FDA Medical Device Regulations
It’s one thing to read the requirements set forth by the Food & Drug Administration (FDA) for medical device developers. It’s another thing entirely to know when – and how – to apply those rules to the medical device development process.
For example, the FDA requires that formative and summative studies be conducted during the medical device development process. This work requires product developers to assess the potential risks that their product may pose to its users.
But the spirit of these medical device regulations, as any experienced product developer knows, is to use the data from this work to evolve and iterate on your product’s design.
Apply Medical Device Regulations Early On
A crucial mistake that many medical device developers make is to interpret these studies as just another box to check off in their regulatory package. This approach leads to companies developing technologies all the way to the clinical trial stage, then moving to satisfy medical device regulations.
At this point, many developers discover that significant changes to the product’s design will be needed to meet FDA regulations. Ultimately, holding off on applying medical device regulations often leads to added costs and delays to the product’s launch schedule.
By practically applying medical device regulations early on in the product development process, product developers can ensure a safe and effective product to better meet user needs.
Medical Device Verification & Validation Testing
Another crucial hurdle that companies must overcome in the medical device development process is establishing a thoughtful and appropriate testing plan for their verification and validation efforts.
Design Verification Vs. Validation
Per the FDA, design verification is “confirmation by objective evidence that design output meets design input.” Design validation “means establishing by objective evidence that specifications conform with user needs and intended use.”
Design verification: I made the product correctly.
Design validation: I made the correct product.
An experienced product development company can assist in creating and executing verification and validation studies that will enable your company to meet the FDA’s medical device regulatory requirements while minimizing burden.
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.
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
Organizing Your Submission Package to Optimize Approval Chances
There is a ton of data involved in a regulatory submission package. Knowing what goes into this package is essential learning for all product development teams. Your team must also know how to organize the submission package to make it easy for the regulator to understand – thereby increasing the chances your device or system is approved.
A skilled product development team knows what FDA regulators are looking for in a 510(k) or PMA package and can help you create an application that meets the regulator’s needs.
This is especially important for companies that are taking a medical device from the European market and requesting approval by the FDA in the United States (or vice versa). The regulatory requirements are similar in both markets and most companies will have all the right information in their submission packages. But the trick is organizing the data appropriately so it is most accessible to the market regulators.
Optimizing Your Product Development Plan
There is no shortage of skilled regulatory firms on the market that can help your company put together a package of data to submit to the FDA. But often this work happens after the product is already developed – “Show me your data and I’ll help you put the package together.”
The benefit of partnering with a product development firm with experience in medical device regulations is that they can map out the design and development work needed to meet scheduled business milestones and regulatory requirements.
Having a development partner that knows the regulatory landscape can even save you money by recommending the appropriate level of rigor required at each and every stage of the product development process. Select a firm that knows exactly how much work you’ll need to do at each step – no more, no less – to satisfy regulators and create a highly effective product.