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  1. Emergency Situations (Medical Devices)

Medical Device Types to Help Determine Section 506J Notification Obligations

Contains Nonbinding Recommendations

This list is part of Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff. This list represents FDA’s recommendations based on its current understanding of the device types and corresponding product codes that manufacturers should consider to determine whether they are required to notify FDA under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) during the COVID-19 pandemic. This list is not exhaustive, and FDA intends to update this list as the COVID-19 pandemic evolves.

This list of device types and corresponding product codes identifies devices that FDA believes are critical to the public health during the COVID-19 pandemic under section 506J(a)(1). However, FDA may make additional device type determinations under section 506J(a)(2) and update this list with respect to device type recommendations under section 506(J)(a)(1) as this public health emergency evolves and if FDA learns new information.

Manufacturers of device types that are included on this list should review section 506J of the FD&C Act, as well as other parts of FDA’s guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised) – Immediately in Effect Guidance for Industry and Food and Drug Administration Staff, to determine whether they are required to notify FDA under section 506J of the FD&C Act.

If a device type is not included on this list, but you believe it requires a notification under section 506J of the FD&C Act, or if you have questions regarding the device types on this list, you should contact FDA at CDRHManufacturerShortage@fda.hhs.gov and include “List Question” in the subject line of the email.

Comments regarding this list can also be submitted to the docket at https://www.regulations.gov. All docket comments should be identified with the docket number FDA-2020-D-1138 and complete title of the guidance in the comment.

Device Types Examples Product Code
Clinical Chemistry Products Critical Care Tests, Tests That May Monitor COVID-19 Progression CEM, CEO, CFA, CGL, CGX, CGZ, CHL, CIC, CJY, JFL, JGJ, JGS, KHP, KHS, LFR, NBW, PZI, CGR, CIG, CIT, CIX, CJE, JFM, JFT
Dialysis-Related Products Dialysis Accessories, Dialyzers FID, PQK, FIG, FIR, FJD, FJF, FJI, FJK, FJT, FKB, FKJ, FKO, FKR, FLA, KDJ, KDL, KOC, KPF, KPO, LFK, LLB, MLW, MPB, MQS, MSD, MSY, NQJ, NYU, PEH, PFH, PKI, PPJ, FIL, FKP, FKQ, KDI
General ICU/Hospital Products Air Purifiers, Beds, Cleaning Products, Feeding Tubes, GI Catheters FRA, FRF, FNJ, FNK, FNL, FPO, KMG, MDZ, MEC, PSB, PSC, KNT, BSS, PIF, EZL, EOQ, KTI, PSV, FKK, KOD, FRR, LGM, LGN, PEZ, PWQ, FMK
Hematology Products Oxygenation Tests, Clotting Tests DAP, GJS, GKR, JKS, JPA, MVU
Infusion Pumps and Related Accessories Infusion Pump Accessories, Pumps FMG, FOX, FOZ, FPA, FPB, FPK, KPE, KZD, LDR, LJS, LJT, MJF, MRZ, OJA, PND, PTI, FRN, MEA
Microbiology Products Flu Assay and Media DCK, OEP, OTG, OZE, PSZ, QDS, QKP
Needles and Syringes N/A FMF, FMI, MEG
Personal Protective Equipment (PPE) Gloves, Gowns and Surgical Apparel, Respirators, Surgical Masks FMC, KGO, LYY, LYZ, LZA, LZB, LZC, OCP, OIG, OPA, OPC, OPI, PXC, QDO, IWP, OXZ, FME, FXO, FXP, FXY, FXZ, FYA, FYB, FYC, LYU, OEA, BWP, FXW, FYE, FYF, MSH, NZJ, ONT, ORW, FXX, OUK
Sterilization Products EtO, Steam, Sterilization Accessories FLF, FLI, MLR, FLE, KCT, MED
Testing Supplies and Equipment Generic Analyzer, Reagents, Specimen Container, Specimen Collection, Transport Media, Swabs, Vials PFF, PPM, PFT, KDT, KDW, LIO, JSM, JSL, JSN, JTW, JTX, JSG, CBD, KXG, JKA, OYJ, QBD, JJH, JQW, KHO, LXG, NSU, OOI, JKA
Ventilation-Related Products Anesthesia, ECMO, Tracheostomy Related Devices, Ventilator, Ventilator Accessories BSZ, BYS, DRY, DTL, DTM, DTN, DTP, DTQ, DTR, DTS, DTW, DTX, DTY, DTZ, DWA, DWB, DWC, DWD, DWE, DWF, DXS, JOD, JOR, KFM, KRI, KRJ, KRL, MJJ, MNJ, NCP, OET, OEU, PTN, PZS, QJZ, BTR, NMA, NXA, OGP, OGV, OGW, LRQ, BTL, BZD, CBK, MNS, MNT, NHJ, NOU, NQY, ONZ, NFB, BTT, BYE, BYG, BZE, BZO, CAI, CAT, CAW, MOD, NHK, OQU, QAV, CAH, OFP
Vital Sign Monitoring Cardiac monitors, Multiparameter Monitors, Respiratory Monitors Thermometers DQD, PLB, DPS, QDA, MWI, DRG, DRT, MHX, MSX, BZQ, FLL, DQA

 

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