FDA Medical Device & Regulations FDA Medical Device Classification

Quality Smart Solutions offers medical device compliance solutions to ensure your device complies with the applicable FDA medical device regulations so that your business can cater to the USA marketplace.

What are Medical Devices and does my facility need to be registered?

A medical device is any instrument, apparatus, implement, machine, or contrivance, including any component part or accessory which is:
● intended by the manufacturer to be used for human beings for one or more of the following purposes:
● diagnosis;
● therapy;
● surgery; or
● prevention of disease which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means.

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. 

Medical Device Compliance in the USA

Medical devices include a wide range of medical or health instruments that are used for treating, mitigating, diagnosing, or preventing diseases or abnormal health conditions. These devices can be hip implants, pacemakers, artificial heart valves, syringes, thermometers, contraceptive devices, and medical laboratory diagnostic instruments. 

Medical devices are classified into Class I, II, and III in the USA. While most of the Class I devices are exempt from Premarket Notification 510(k), most of the Class II devices need Premarket Notification 510(k). Class III devices require Premarket Approval. All classes of medical devices in the USA need to be manufactured and approved under FDA regulations.

GUDID Database and Unique Device Identifier (UDI):

The GUDID database is a repository of unique device identifiers for medical devices in the United States. They are issued under an FDA-accredited issuing agency (Like GS 1). The manufacturers will get their device UDI number from an accredited issuing agency and register the UDI in GUDID.

The Unique Device Identifier (UDI) is a 17-digit numerical code that can be used to identify each medical device. The UDI was developed to facilitate tracking, tracing, and recall of medical devices in the event of a safety issue or if one is recalled.

A unique device identifier is required for all medical devices unless they are FDA-exempt. For example, most Class I and II devices do not require a UDI because they have a low risk of adverse health consequences; however, some Class I and II devices do require this identifier when they are considered higher risk.

The FDA requires your establishment to register with their Global Trade Identification Number (GTIN) database before submitting your 510(k) application or before being granted access to other databases within their website such as the Premarket Notification Database (PMN).

Establishment Registration

Domestic and foreign manufacturers, distributors, or importers of medical devices in the USA must register their establishment with the FDA.

Suspension of an Establishment Licence

Your establishment license will be suspended if you fail to comply with regulations or present misleading statements in the application.

FDA Inspection

Every medical device manufacturing facility undergoes FDA inspection to ensure compliance with quality standards.

FDA Classification of Medical Devices

Quality Smart Solutions offers end-to-end compliance assistance in product classification, regulatory strategic planning, submission approval process, interaction with regulatory agencies during development stages, and preparation of fulsome application dossiers (including a detailed list of documents, reports, diagrams, or clinical data that are required for medical device registration).

510(k) Medical Device Registration

Former FDA specialists will review testing requirements, check relevant FDA guidance documents, ensure you meet required standards to have your medical device registered.

Medical Device Facility Registration and FURLS Listing

Avail support in getting the FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), thereby getting your facility registered.

In Vitro Diagnostic Device 510(k) Registration

Leverage our expertise in submitting your application for In Vitro Diagnostics (IVD) or filing a Premarket Notification with the FDA, also known as an FDA 510(k). Call for step-by-step guidance.

SaMD Classification and Registration

Register your SaMD with FDA with the help of our software device licence experts. We will assist you in the process based on risk evaluation, inclusion and exclusion.

Why are FDA Medical Device Regulations important?

The USA has the world’s top regulatory systems to make certain that every medical device sold in the country is safe and effective for human health. The Center for Devices and Radiological Health (CDRH) under the FDA is responsible for monitoring companies that manufacture, repackage, relabel and import medical devices for sale. All classes of medical devices need to be developed at a site that maintains quality standards. If the equipment is manufactured outside of the USA, the devices must comply with the quality standard and be brought into the USA only if they meet the standard set by the FDA and United States Customs and Border Protection (CBP).

Product Types we have Licenced

We have licensed a wide range of Medical Devices, including but not limited to below

Invitro Diagnostics
Monitoring Devices
Surgical Equipment
Mobile Aid
Personal Care

Frequently Asked Questions

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
  • recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and
which does not achieve 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 its primary intended purposes
The FDA places all medical devices into one of three regulatory classes based on the level of control necessary to ensure safety and effectiveness of the device. Classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in determining the class to which it is assigned. Class I devices are considered low risk and Class III devices are considered high risk.
A premarket notification, or 510(k), is submitted to FDA before a manufacturer proposes to market a medical device. If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market it immediately. FDA does not require clinical data in most 510(k)s.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. PMA applications are the most stringent type of device marketing application for medical devices. FDA approves a PMA if it determines that the application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

Unless they are class I medical devices the following products will need to be licensed by the FDA:

  • PPE
  • Invitro Diagnostics
  • Monitoring Devices
  • Surgical Equipment
  • Mobile Aid
  • Radiology
  • Pacemakers
  • Personal Care

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