What do You Need to Know About the FDA Regulatory Process to Develop a Medical Device?

A lot of time, dedication, and money goes into developing a new product. It could ruin everything if you get too far without taking into account the FDA regulations in place within the medical device industry. For the good of all of us, companies cannot just run to market with a medical device and tell consumers whatever they want. While it’s understandable the government cannot allow this to happen, it means you’ll have quite a few hurdles to jump through. 

Running a business requires a lot of specialized skills. Just like you’re an expert at what you do, our FDA attorneys are experts at getting FDA approvals, solving FDA problems, how to word your labels, litigation, and more. Human and animal drugs, food, beverages, medical biologics and devices, tobacco products, certain cosmetics, and electronic products that emit radiation all need to be FDA approved before they go to market and are sold to consumers. This means if you’re in the process of developing a medical device, you need to pause and learn the FDA regulations you’ll need to follow. Don’t worry- we can help!

Everything from the way your device is classified to how your product is cleared is complex, and oftentimes confusing for business owners and managers. In order to be sure you have the right paperwork in place, which means you have provided FDA personnel with the right information, it’s best to work with a regulatory expert who understands the legislation and can help you navigate it. That is us! We work with medical device clients all over the world, just like you. We are experts at providing services in a number of applicable areas, including:

  • Device Classification
  • Product Clearance
  • Label Review
  • Export Certificate
  • Advertising Review
  • Off-label Promotion
  • Adverse Event Reporting and Record-Keeping
  • Warning Letter and Border Detention Assistance

Nothing good will happen if you are discovered to be handling your labeling, materials, testing, or other aspects of your product marketing incorrectly. A mistake in this area could derail not only your growth but your ability to stay profitable. For example, a product liability suit involving an injury from a medical device could raise questions regarding FDA approval, off-label use, and product classification. This would be devastating to not only your reputation but also your company’s bottom line. FDA experts are able to help your litigation team understand culpability and duty of care. Bring in our FDA attorneys before a bad situation happens to avoid it all together. 

You don’t need to try and handle something this complex on your own. Attorneys with this kind of specialized expertise can be brought in to ensure your business has the knowledge you need to thrive in the modern marketplace. When you choose to work with us, you will have peace of mind knowing your medical device business is in good hands.

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