Tag: FDA Medical Devices Classification

MEDICAL DEVICES PRODUCT CLASSIFICATION

Medical devices are categorized into different classes based on their risk level and intended use. These classifications of U.S. Food and Drug Administration (FDA) to ensure the safety and effectiveness of these devices. Below are the classification of medical devices by FDA.

Class I: Low Risk

  1. These are considered low-risk devices, typically involving minimal potential harm to the user.
  2. Examples include elastic bandages, examination gloves, and most manual surgical instruments.
  3. General controls are sufficientto provide reasonable assurance of safety and effectiveness.

Class II: Moderate Risk

  1. These devices have a higher level of risk than Class I devices and require greater regulatory controls.
  2. Examples include syringes, infusion pumps, and some diagnostic tests.
  3. Special controls, such as performance standards, post-market surveillance, and patient registries, may be necessary to ensure safety and effectiveness.

Class III: High Risk

  1. Class III devices pose the highest level of risk to patients and usually support or sustain human life, are implanted, or present potential unreasonable risk of illness or injury.
  2. Examples include implantable pacemakers, heart valves, and automated external defibrillators.
  3. These devices require pre-market approval (PMA) applications to demonstrate their safety and efficacy.

Before marketing a medical device, manufacturers must ensure they comply with the relevant regulatory requirements for the intended market. This might involve submitting various documentation, conducting testing, and obtaining the appropriate approvals or clearances from regulatory agencies.

Liberty Management Group, a leading FDA consulting group in the United States provides assistance with classification of devices and establishment registration, device listing, medical device label review, UDI listings and US agent service for foreign drug establishment firms.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

CLASSIFICATION OF MEDICAL DEVICES

Medical Devices are any instrument, appliance, machine, software or any other device including part or accessory of a device which is

  • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
  • Intended to diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

FDA has categorized classifications of nearly around 1,700 different generic types of devices and collected them into 16 medical specialties referred to as panels. Medical devices are classified in to Class I, Class II or Class III depending upon the risk of the device.

  • Class I devices are in general recognized as low risk devices with general controls with or without exemptions.
  • Class II devices are in general recognized medium risk to the user with general controls and Special control with or without exemptions.
  • Class III devices are recognized as high risk device that support life, and present high risk of illness and injury. Class III devices requires general controls, special controls and also premarket approval.

Classification of devices depends upon the intended use and indications for use of the device. Device classification can be found in two ways, one is to check at Classification database or can be checked at device panel at which the device belongs to.

Companies that involved in manufacturing and distribution of medical devices intended for commercial distribution are required to register with FDA annually and pay fees. Most companies are required to list their devices and need to notify the activities done on those devices at their establishment.

If a device requires Premarket notification (510K) or Premarket approval (PMA) or Humanitarian Device Exemption (HDE), the owner/operator should get above clearance from FDA before they start marketing the device in US.

All Medical devices marketed in United States has be in compliance with FDA labeling requirements, if not, FDA will considered them as misbranded.

Liberty Management Group Ltd, provides assistance with medical device establishment registration, device listings, label review and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

www.fdahelp.us