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
Hi.. i have a product which is a first aid kit comprising of medical gloves, antiseptic wipes and alcohol pads. How do i register with FDA? Is it a medical device as per FDA?
It depends upon the intended use of it and only the manufacturer needs to decide which way to list.
Either they can list it as a medical device (first aid kit – combination product) or list it a drug (first aid kit with a medical device). In both cases, each product inside kits needs to be registered with FDA and listed with FDA.
I want to register as a specification developer now but later i am going to manufacture the device as well, Should i re-register then? Do i need to pay the fee again? What is the listing requirement for me now and then? Thanks
You don’t need to register again as a manufacturer, but needs to update the establishment registration as a manufacturer. Regarding device listings, you need to update that as well as manufacturer. No need to pay FDA fees again.
Thank you Sudha. What will be the fee for registering the first time and then again for updation? Please tell me total fees – your fee and FDA fee and timeframe.
For first time registration FDA fees would be $4884 for FY 2019 and our fees would be $449/year. There is no extra fees for updating the registration. For Class I devices we can complete the establishment registration within 7 to 10 business days.