How an Effective FDA Regulatory Strategy Can Streamline FDA Approval and Clearance

Developing a new medical device is a challenging process. It requires a thorough understanding not only of the needs and requirements of your customer, but also of the regulatory environment in which you bring the product to market. While product development is the first step in bringing your product to market, the regulatory approval process for medical devices must be top of mind from the early stages as well. An FDA regulatory strategy developed at the beginning of the process makes your regulatory pathway easier. Learn more about what a regulatory strategy is and why it’s so important.

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The FDA Medical Device Approval Timeline: How Long Does it Take?

The U.S. Food and Drug Administration (FDA) regulates everything produced by drug and medical device companies. The FDA approval process is designed to ensure that every product on the market meets certain standards of safety and effectiveness. However, it can be confusing for anyone trying to navigate it independently. Here’s what you need to know about the FDA medical device approval timeline — plus some tips on navigating the regulatory process with as few hurdles as possible.

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Understanding Regulatory Strategy For A New Medical Device

Regulatory strategy is an important component of product development for FDA Approval/Clearance. If you have a new medical device and want to bring your product to market with minimal delay, prepare your medical device regulatory strategy early in the development process. In this article, we will discuss how to approach your regulatory strategy so that you can bring your device to market as quickly as possible.

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What Is Software as a Medical Device?

Software as a medical device (SaMD) products are everywhere in the healthcare industry — and beyond! They play an important role in the way that doctors interact with patients, how patients manage their own health (like tracking their wellness on smartphone apps), and how hospitals function on a daily basis. But what exactly is SaMD? And what makes it a medical device?

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How To Determine FDA Medical Device Classification

Medical devices are any type of device used for diagnosis, treatment, or prevention of disease or other medical conditions. The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States, from contact lenses and hearing aids to stents and defibrillators. To ensure devices are safe and effective, the FDA has developed a medical device classification system based on their risk profile. Before starting your regulatory pathway, you must determine your product’s correct classification.

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