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PPE
MEDICAL DEVICES

Personal Protective Equipment (PPE) refers to gowns, gloves, face shields, goggles, facemasks, and respirators or other equipment designed to protect the wearer from the spread of infection or illness.

PPEs are regulated by the FDA as medical devices.

  • 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)
  • Personal protective equipment used with other infection control practices such as hand-washing, alcohol-based hand sanitizers, and covering coughs and sneezes, minimizes the spread of infection from one person to another
  • The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
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.

N95 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).

Lowest FDA REGISTRATION fees are available here.

CONTACT ITB HOLDINGS LLC

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.

$5,236.00 | Establishment Registration Fee, annual (FY 2020)
Keep in mind that this fee will increase on October 1, 2020.

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

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.