Why FDA Registration is Essential

Entering the U.S. market with a medical device requires compliance with FDA regulations to ensure patient safety and product effectiveness. FDA registration is mandatory for manufacturers, importers, and distributors to legally market medical devices in the U.S.

• Legal Compliance: Devices must meet FDA standards to be lawfully sold and distributed.

• Market Access: Without FDA registration, medical devices cannot be imported or sold in the U.S.

• Patient Safety Assurance: Ensures that only safe and effective devices reach consumers.

• Competitive Advantage: Registered devices build credibility and trust among healthcare providers and buyers.

Regulatory Submission Types

Once the classification is identified, the appropriate regulatory submission pathway must be selected:

• 510(k) (Premarket Notification):

  • Required for Class II devices and some Class I devices.

  • The manufacturer must demonstrate that the device is substantially equivalent to a legally marketed predicate device.

  • Typically reviewed within 90 days.

• De Novo Classification:

  • Suitable for new, low-to-moderate risk devices that do not have a predicate.

  • Allows a new product classification when no substantially equivalent device exists.

  • Reviewed within 120–180 days.

• PMA (Premarket Approval):

  • Required for Class III devices that pose significant risk.

  • Requires clinical data to prove the device’s safety and effectiveness.

  • Involves rigorous scientific review and may take up to a year for approval.

Device Classification

The FDA categorizes medical devices into three classes based on risk level:

• Class I (Low Risk): Devices that pose minimal risk to users, such as bandages and manual stethoscopes. Most Class I devices are exempt from premarket notification.

• Class II (Moderate Risk): Devices that require greater regulatory control, such as infusion pumps and powered wheelchairs. These typically require 510(k) clearance to demonstrate equivalence to an already-approved device.

• Class III (High Risk): Devices that sustain or support life, are implanted, or present a high risk of illness or injury, such as pacemakers and artificial heart valves. These require Premarket Approval (PMA) and clinical evidence to support their safety and efficacy.

How We Can Help

At PreCert, we guide medical device manufacturers through the complex FDA regulatory landscape. Whether you need assistance determining your device classification, preparing a 510(k) submission, navigating the De Novo process, or compiling a PMA application, our experts provide end-to-end support to help you achieve FDA approval efficiently.