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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.

Understand Device Classification

How your device is classified depends on both its risk and intended use within the healthcare field. The FDA (Food and Drug Administration) classifies medical devices into three categories: Class I (lowest risk), Class II (moderate risk), and Class III (highest risk). It’s important to understand your device’s risk classification before developing a regulatory strategy.

Class I

Class I devices are low-risk with less strict regulatory controls for market entry. Class I devices do not sustain life, nor do they have extended use in or on the body. Examples include stethoscopes, tongue depressors, and bandages.

Class II

Class II devices are more complicated and have a slightly higher risk than Class I. They may have extended contact with the patient, including internally. They are subject to more regulatory controls than lesser-risk medical devices. Examples include syringes, blood pressure cuffs, and contact lenses.

The regulatory strategy for Class II devices may differ from product to product. If there is a predicate device for the product (another device with substantial equivalence, including technology and intended use), the device will follow the Class II regulatory pathway to approval. If there is no predicate device currently on the market, Class III requirements apply, including a De Novo classification for risk assessment.

Class III

Class III devices are implanted, sustain life, or present significant risks if misused. Because of this risk and intended use, Class III products go through the most extensive regulatory submission process, including pre-market approval (PMA) submissions to regulatory agencies. Examples include pacemakers, ventilators, and coronary stents.

Know the Regulatory Requirements

The first step to developing a regulatory strategy is understanding what requirements your product needs to comply with based on where your product with be marketed. Device classification will determine the regulatory requirements for your product. In addition, FDA Guidance Documents, Standards, QMS requirements, and other regulatory information (regulatory intelligence) should be used as inputs to prepare a successful regulatory strategy.

De Novo Classification

De Novo Classification determines whether your product needs general controls or special controls depending on the risk associated with the device. De Novo requests are required when there is no predicate device currently approved on the market.

Good Manufacturing Processes (GMP)

Good Manufacturing Processes (GMP) ensure that medical device manufacturers in the U.S. create and develop medical devices that are safe and meet quality system regulations. These regulations are outlined in 21 CFR Part 820.

Quality Management System (QMS)

Quality management systems ensure that a company meets and maintains quality standards and regulatory requirements.


An FDA pre-submission is a formal request for feedback from the FDA before submitting your 510(k) or to gain an understanding on a specific topic with FDA. A pre-submission allows a company to bring its device to market efficiently because you are aware of possible issues and can address them before you submit your 510(k) to FDA.


A 510(k) premarket notification demonstrates to the FDA that the Class II device is safe and effective as a predicate device on the market. The submitted 510(k) must show substantial equivalence to a device on the market.

Premarket Approval (PMA)

A premarket approval (PMA) application is a requirement for Class III devices. It is more in-depth than a 510(k) because of the increased safety risks associated with that classification of devices.

Investigational Device Exemption (IDE)

Investigational device exemption permits usage of the device to collect clinical data on safety and effectiveness before gaining approval. An IDE is required for your product to be used in these clinical studies.

Post-Market Surveillance (PMS)

Your regulatory strategy doesn’t end when you get your medical device to market. Post-market activities monitor the performance of your product. PMS strategies address complaints and work on recall crisis management.

Be Prepared Early In The Product Development Process

A regulatory strategy should be part of your product development process as early as possible. It should be developed early, reviewed, and updated as needed based on regulatory changes – then subsequently reviewed and updated after each stage of product development. Being prepared is the best way to get your product on the market with the fewest hurdles.

A Guide For FDA Approval In The Medical Device Industry

Medical device regulatory requirements can change regularly. Staying up to date on these changes is the best way to get your device on the market and keep your device on the market. A regulatory strategy for your medical devices should also maintain the product life cycle requirements, including post-market activities to ensure your device meets these regulations.

Need help with a regulatory strategy? The experts at A Wright Path can help develop your regulatory pathway and guide you through the process. Schedule a consultation today!

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