11 COVID-19 Guidance Documents were released by the FDA, allowing the distribution and use of certain medical devices with the omission of some regulatory requirements including premarket review.

See below for specific product changes.

EUA Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators

FDA does not intend to object to the distribution and use of masks or respirators intended for a medical purpose without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: FXX, OXZ, LYU, OUK, MSH, ONT, ORW, NZJ.

EUA Respiratory Masks, Gas Masks, Oxygen Masks, and Ventilatory Masks

FDA has a Pre-EUA process to quickly determine if your mask may be distributed and used for a medical purpose without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling under an existing or new EUA. Please contact Arazy Group for consultation.

Product Codes included: OBN, BTT, BSJ, BYG, KGB, NHK, NMC, BTK.

EUA Decontamination of Face Masks and Filtering Face-piece Respirators

FDA does not intend to object to the distribution and use of masks or respirator decontamination systems without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices if certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

EUA Digital Health Devices for Treating Psychiatric Disorders

FDA does not intend to object to the distribution and use of computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders, or Low-risk general wellness and digital health products for mental health or psychiatric conditions, without compliance with without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place to treat Obsessive Compulsive Disorder, Generalized Anxiety Disorder, Insomnia Disorder, Major Depressive Disorder, Substance Use Disorder, Post-traumatic Stress Disorder, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: PWE

EUA Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices

FDA does not intend to object to certain modifications to the indications or design of FDA cleared or approved ECMO and bypass devices labeling for qualifying devices as long as certain conditions are in place without prior submission of a premarket notification or premarket approval application supplement where the modification does not create an undue risk in light of the public health emergency. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: QJZ, BYS, PZS, KRI, KRL, NCP, DWF, OEU, DTQ, DTP, DTR, OET, DWC, DTM, JOD, KRJ, DTL, DTX, DXS, JOR, DRY, DTW, DTZ, KFM, DWB, DWA, DWE, DTN, MJJ, MNJ, PTN, DTY, DTS, DWD.

Remote Ophthalmic Assessment and Monitoring Devices

FDA does not intend to object to limited modifications to the indications, functionality, hardware, and/or software, of 510(k)-cleared devices for remote assessment and monitoring of ophthalmic parameters, or distribution and use of these device types that are exempt from submission of a 510(k) such as Visual Acuity Charts, Visual Field Devices, Ophthalmic Cameras, and Tonometer without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: PJZ, HOX, HOQ, HOO, HPT, HKX, HKY.

Infusion Pumps and Accessories

FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials or labeling of FDA-cleared devices for qualifying devices as long as certain conditions are in place used to support patients who require continuous infusion therapy, without prior submission of a premarket notification under section 510(k). To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: FRN, MEA, MRZ, PHC, MAJ, KPE, FOZ, PND, PUK, KZD, FPA, FMG, FPB, MJF, PWH, PYR, OKL, PTI, LDR, LJT, PTD, LJS, OKC, OMF, FOX, LKG

Clinical Electronic Thermometers

FDA does not intend to object to the distribution and use of electronic thermometers for qualifying devices as long as certain conditions are in place intended for a medical purpose without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: FLL

Gowns, Other Apparel, and Gloves

FDA does not intend to object distribution and use of surgical gowns, shoe covers, isolation gowns, surgical suites, caps, hoods, or other surgical apparel such as examination gloves, for qualifying devices as long as certain conditions are in place intended for a medical purpose without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation

Product Codes included: BWP, FXW, LYU, OEA, FXO, FXP, FXZ, FYE, FYF, FYA, FYB, FYC, FXY, FMC, LYY, LZA, LZB, LYZ, OIG, OPC, OPH, LZC, KGO, OPA.

Sterilizers, Disinfectant Devices, and Air Purifiers

FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, or air purifiers for qualifying devices as long as certain conditions are in place intended for a medical purpose without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: KOK, ECC, FLI, MLR, PJJ, FLF, KMH, FLE, PEC, FEB, MED, MEC, MDZ, OUJ, PSW, FRF, FRA

Ventilators and Accessories and Other Respiratory Devices

FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification for qualifying devices as long as certain conditions are in place for a medical purpose without 510(k) clearance, registration and listing, quality system regulation, corrections and removals, or UDI labeling for qualifying devices as long as certain conditions are in place. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: CBK, MNT, NOU, NQY, MNS, ONZ, BTL, BSZ, BZD, NFB, NHJ, NHK, QAV.

Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA cleared non-invasive remote monitoring devices for qualifying devices as long as certain conditions are in place that are used to support patient monitoring. To see if your product qualifies to be distributed and used under this EUA please contact Arazy Group for consultation.

Product Codes included: FLL, DPS, DRT, MWI, MSX, PLB, QDA, DQA, DXN, BZQ, DQD.

Reference for more information here

Arazy Group’s

Successful Experience

Arazy Group’s expert team has experience submitting EUA and PEUA applications, for example the recent submission of PEUA 200378 for IntegriMedical‘s innovative Needle Free Injection System.

 The Needle Free Injection System utilizes high velocity mechanical actuation to inject Covid-19 vaccines or treatment pharmaceuticals interdermally (ID), subcutaneously (SC) and by intramuscular (IM) administration. 

We also have experience submitting applications to Health Canada under the current “Interim Order” for fast market release in Canada of Covid-19 devices.

Interested in setting-up a short 15- minute meeting to chat about your product?

Get in Touch with us for More Information!

Our team will reach out to discuss your company’s personal registration projects or any inquiries you may have. 


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