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PPE

Personal Protective Equipment as Medical Device

MEDICAL DEVICES

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 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 feature to search by keyword(s). Please note, you may need to conduct multiple searches using a variety of keywords that describe your product (for example, search both “stent” and “stents”).
  •  Advanced Search feature to search by product code, regulation number, or device class.
PREMARKET NOTIFICATION 510(k)

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) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate.

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.

MEDICAL DEVICE ESTABLISHMENT REGISTRATION

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).
Medical Device Shortages

Is your company manufacturing, exporting or distributing other medical devices?

Chest Drains with Autotransfusion Indications
FDA Product Code CAC (Apparatus, Autotransfusion)

Dialysis‐Related Products
FDA Product Code KDL (Set, perfusion, kidney, disposable)

Dialysis-Related Products
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))

FDA USER FEES

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.

CURRENT FISCAL YEAR (FY 2022) USER FEE

$5,672.00 | Annual Establishment Registration

$3,186.00 | 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.

ESTABLISHMENT REGISTRATION

MEDICAL DEVICES

$350.00

  • Annual Service Fee
  • Company Registration
  • Product Listing
  • U.S. Agent Service
LIMITED OFFER

User Fee is extra.

MEDICAL DEVICE UPDATES

Monkeypox Testing

The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing. Testing samples not taken from a lesion (rash or growth) may lead to false test results.

The CDC’s FDA-cleared non-variola orthopoxvirus test can detect monkeypox from a lesion sample.