New FDA Guidance Document Changes- COVID 19

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.

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.

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

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.

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.

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

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

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.

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

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.

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.