Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
Ventilators, anesthesia gas machines, other respiratory medical devices, and their accessories, are needed to support COVID-19 patients.
- PPE is commonly used in health care settings such as hospitals, doctor’s offices and clinical labs
- When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose, or eyes (mucous membranes)
- The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
You may search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product:
Quick Search by keyword(s). Please conduct multiple searches using a variety of keywords that describe your product (for example, search both “stent” and “stents”).
Most Class II (moderate risk) devices require a Premarket Notification 510(k) clearance from the FDA before they may be legally marketed.
A Premarket Notification 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is “substantially equivalent” to a legally marketed device, which is not subject to Premarket Approval (PMA).
For purposes of determining substantial equivalence, the legally marketed device is commonly referred to as the “predicate device” or “predicate”.
Features can be added to a new device to increase convenience of use and/or functionality, without altering the intended use or risk profile (relative to a predicate) of the new device.
Substantial equivalence means that the new device is as safe and effective as the predicate. Manufacturers must compare their device to a similar legally marketed device to support its substantial equivalence.
In most cases, FDA will provide the opportunity for the manufacturer to respond to initial concerns regarding the equivalency of the new device’s intended use or technology to a predicate device via response to a request for additional information (typically related to performance testing).
N95 respirators intended for use in a health care setting during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material, are regulated under product code MSH, class II medical devices exempt from 510(k) Premarket Notification.
There are several exceptions.
Which N95 respirators are not exempt from Premarket Notification 510(k)?
- intended to prevent specific diseases or infections
- labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity
- contains coating technologies unrelated to filtration (reduce and or kill microorganisms).
National Institute for Occupational Safety and Health (NIOSH)-approved devices are exempt from FDA’s Premarket Notification 510(k) requirements, subject to applicable conditions and limitations to the exemption.
For devices that exceed the threshold evaluation criteria and/or exceed the conditions and limitations of the exemption, FDA will review the required Premarket Notification 510(k) submitted to the Agency.
The FDA will consider information provided by NIOSH regarding whether applicants’ devices meet the approval criteria. This will allow FDA to focus on other relevant aspects of the device in its substantial equivalence review.
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 with the U.S. Food and Drug Administration.
Registrants are also required to submit registration information for their establishments on or before December 31 of each year.
Failure to register is a prohibited act. Finally, a medical device is misbranded if it is manufactured in an establishment not duly registered.
A foreign company or registrant must provide the name, address, and phone number of its U.S. Agent such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
- Annual Service Fee
- Company Registration
- Product Listing
- U.S. Agent Service
User Fee is not included.
Under the Medical Device User Fee Amendments (MDUFA), medical device companies pay fees to the FDA when they register their establishments and list their devices.
FISCAL YEAR (FY 2023) USER FEE
$6,493.00 | Annual Establishment Registration
$4,967.00 | Premarket Notification 510(k) application (with Small Business Certification)
Payment of User Fees to the U.S. Treasury requires an account. Please seek our assistance, if needed.
FDA is using Dun & Bradstreet Inc to conduct verification of medical device facility information provided to the agency by registered and listed medical device manufacturers.
Therefore, all domestic and foreign companies must request or have a DUNS Number.
Is your company manufacturing, exporting or distributing other medical devices?
Chest Drains with Autotransfusion Indications
FDA Product Code CAC (Apparatus, Autotransfusion)
FDA Product Code KDL (Set, perfusion, kidney, disposable)
FDA Product Code KDN (system, perfusion, kidney)
Chest Drains and Suction Canisters
FDA Product Code KDQ (Bottle, Collection, Vacuum)
Cardiac Diagnostic and Monitoring Products
FDA Product Code MKJ (Automated External Defibrillators (AEDs) (Non-Wearable))
Cardiac Diagnostic, and Monitoring Products
FDA Product Code MVK (Automated External Defibrillators (AEDs) (Wearable))