ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
FDA TEAM
FDA CONSULTANTS

Just image having your own FDA Compliance Department for the fraction of the cost! No salary or bonus to pay.

What to Expect from our Consultants

Multilingual

  • French
  • Spanish
  • German
  • Dutch
  • Other languages

 

■ Multinational

■ Work extended hours so you do not have to

  • Available for Live Support chat, 24 hours a day and 7 days a week
  • Respond to emails within 30 minutes

Our consultants assist companies in Canada, Mexico, Brazil, Australia, New Zealand, India, Pakistan, South Korea, Japan, China, Russia, Portugal, Greece, Spain, France, Belgium, Netherlands, Switzerland, Sweden, United Kingdom, Ireland, among more than 100 countries.

We understand that the FDA issued an updated Letter to Health Care Personnel and Facilities stating that the FDA no longer authorizes use of non-NIOSH-approved or decontaminated disposable respirators.

The FDA has revoked the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems (revocation effective June 30, 2021).

As of the effective date of the revocations, these devices are no longer authorized for use in health care settings.

Because FDA Registration of their establishments is required to market these products in the United States, manufacturers, exporters and distributors of Personal Protective Equipment (PPE) and Hand Sanitizers are invited to contact our consultants.

Make sure to provide the following, when you contact us:

  • Company name
  • Complete physical address
  • Company DUNS Number
  • Products details