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.
What Is a Regulatory Strategy?
A regulatory strategy for FDA approval is a plan that outlines the process a medical device company will take to navigate the regulatory process and obtain clearance or approval from the U.S. Food and Drug Administration (FDA) or other worldwide regulatory bodies for a medical product. Medical products that require FDA clearance include medical devices, combination products (a medical product that combines two or more distinct components, such as a drug and a device or biological products), and drug development.
Regulatory strategies include a plan for submitting the necessary documentation and data to the FDA, as well as outlining the clinical trials and nonclinical studies (Bench and/or performance testing, Biocompatibility testing, Packaging testing, etc.) that need to be conducted in order to demonstrate the safety and effectiveness of the medical product. FDA guidance documents are issued by the U.S. Food and Drug Administration to provide information on FDA requirements and/or what FDA thinks about a topic. These guidance documents provide guidance on regulatory submission requirements for certain devices and/or testing requirements, Good Manufacturing Practices (GMP), the development and review of medical devices, and regulation clarifications. An FDA consultant can help you navigate these regulatory requirements and submissions.
The Medical Device Development Process
A regulatory strategy is an essential part of the medical device development process. Before selling or manufacturing a medical product in the United States, you must follow FDA regulations in order to bring the medical device or new drug product to the market. In order to make your regulatory pathway easier, regulatory requirements should be considered early on in the development process.
The Regulatory Pathway Isn’t Straightforward
The regulatory pathway looks different for every medical product because of intended/indications for use. Medical products vary in usage and risk, so certain devices may have more requirements and additional submission needs. Regulations are constantly changing; developers must focus on regulatory requirements in the product life cycle such as throughout every stage of development, testing, manufacturing, and even after the device is on the market. Partnering with an FDA consultant can help you reach approval with fewer hurdles, ensuring all regulatory requirements are fulfilled during the product life cycle.
Regulatory Requirements Unique to the Product
Every medical product’s regulatory pathway is different since most regulatory requirements are based on the medical device’s classification. Medical device classes depend on the medical product’s intended/indications for use and risk factor — Class I being the lowest risk and Class III being the highest. Determining your device’s appropriate classification involves so many factors that consulting an expert in regulatory affairs is the best way to determine your device’s appropriate classification.
The FDA classifies medical devices as either Class I, Class II, or Class III.
Class I
Class I devices have the lowest risk. They are not life-sustaining, life-supporting, or implantable devices. Examples include bandages, oxygen masks, electric toothbrushes, and non-electric wheelchairs. Most medical devices on the market fall into the Class I category.
Class II
Class II devices are medium risk. They are more likely to have sustained contact with a patient compared to Class I devices. Class II has the widest range of regulatory requirements between medical devices. Examples include thermometers, contact lenses, catheters, and syringes.
Class III
Class III devices have the highest risk for the patient’s health or safety if misused. They usually sustain or support life or are implanted. Only about ten percent of medical devices fall into this classification. Examples include cochlear implants, pacemakers, defibrillators, and high-frequency ventilation devices.
Even within the classes, the regulatory pathway varies from product to product. For example, some Class II products require a 510k, but other Class II products do not. While it is generally true that Class I devices do not require a 510k, some might. A 510k is a submission to the FDA which demonstrates that the product is substantially equivalent to a similar device already on the market.
Your regulatory strategy all depends on the product and how it is intended to be used. An FDA regulatory strategy consultant can help you understand these regulatory requirements, and how your product fits into it all.
Regulatory Submission Planning
Getting a medical device to market means identifying a regulatory strategy and submitting the appropriate documentation to regulatory bodies along the way, including FDA. The exact submissions, clinical study information or non-clinical studies, and testing all depend on your device — making an FDA consultant even more important.
A Partner For Your Regulatory Pathway
The experts at A Wright Path can work with you to determine your FDA regulatory strategy. They understand regulatory requirements and stay up to date with any changes, so you can get your medical device to market with as few hurdles as possible. Contact the regulatory strategists at A Wright Path to get on the Right Path, Right Now, and make the FDA approval process as smooth as possible. Schedule a consultation today!
