506J Device List

Update: November 16, 2023

The FDA’s final guidance: “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” (“506J Guidance”) addresses section 506J of the FD&C Act, as it relates to notifying the FDA of a permanent discontinuance or interruption in the manufacturing of certain devices likely to lead to a meaningful disruption in the domestic supply of that device during, or in advance of, a public health emergency. 

When finalized, the FDA’s draft guidance, “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications,” will represent the FDA’s current thinking on the guidance “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.” Specifically, this draft guidance includes the 506J Device List that, when finalized, will serve as the list for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 506J to the statute. Section 506J provides the FDA with authorities intended to help prevent or mitigate medical device shortages “during, or in advance of, a public health emergency” declared by the Secretary under section 319 of the Public Health Service Act.

In December 2022, the Consolidated Appropriations Act, 2023 (hereafter referred to as the “FY 2023 Omnibus”) was signed into law. Section 2514(c) of the FY 2023 Omnibus directed the FDA to issue or revise guidance regarding requirements under section 506J and to include a list of each device product code for which a manufacturer of such device is required to notify the FDA in accordance with section 506J. Additionally, section 2514 of the FY 2023 Omnibus amended section 506J to add section 506J(h), “Additional Notifications,” and directed the FDA to issue guidance to facilitate voluntary notifications.

What is the 506J Device List?

The FDA has issued a draft guidance that proposes a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J (hereafter referred to as the “506J Device List”). When the guidance is finalized, manufacturers of a device on the 506J Device List must notify the FDA in accordance with requirements outlined in section 506J for each such device. 

For more information, manufacturers should see the 506J Device List proposed in conjunction with the draft guidance. The device types and corresponding product codes included on the 506J Device List include those medical devices that the FDA has determined to be critical to public health within the definition of section 506J(a)(1) of the FD&C Act. The FDA expects that this list will evolve over time and intends to reevaluate it periodically. Revisions to the 506J Device List will follow the FDA’s good guidance practices. 

The FDA also convened an Advisory Committee Meeting on February 6, 2024, to discuss medical device supply chain resiliency and device shortages issues, including the 506J Device List. The FDA established docket FDA-2022-D-0053 for the draft guidance and docket FDA-2023-N-4807 for the Advisory Committee meeting so that the public could submit comments.

Proposed 506J Device List

Manufacturers of devices that the FDA has identified on the 506J Device List are required to submit 506J notifications to the FDA when the statutory conditions are met (see section 506J of the FD&C Act, as well as Section III.C. of the 506J Guidance for more information on when to notify the FDA).

Device Type	Product Code	Product Code Preferred Name
Airway Connectors, Tubing, and Circuits	BYX	TUBING, PRESSURE AND ACCESSORIES
	BZA	CONNECTOR, AIRWAY (EXTENSION)
	CAI	CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Airway Monitors	CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
	OQU	AIRWAY MONITORING SYSTEM
Airway Needles	BWC	NEEDLE, EMERGENCY AIRWAY
Anesthesia Gas Machines	BSZ	GAS-MACHINE, ANESTHESIA
Anesthesia Masks	BSJ	MASK, GAS, ANESTHETIC
Angioplasty Catheters	DRB	STYLET, CATHETER
	DYB	INTRODUCER, CATHETER
	ONU	DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
Antimicrobial Testing Devices	JTN	SUSCEPTIBILITY TEST DISCUS, ANTIMICROBIAL
	JTO	DISCS, STRIPS, AND REAGENTS, MICROORGANISM DIFFERENTIATION
Aspiration Pumps	BTA	PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
Automated External Defibrillators (AEDs)	MKJ	AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Blood Gas	CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
	JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE
Blood Pressure Cuff	DXQ	BLOOD PRESSURE CUFF
Blood Pressure System	DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Blood Tubing Connectors	FKB	CONNECTOR, BLOOD TUBING, INFUSION T
Breathing System Collection Devices	CBD	BOTTLE, COLLECTION, BREATHING SYSTEM (CALIBRATED)
Breathing Tube Support	JAY	SUPPORT, BREATHING TUBE
Bronchoscope Accessories	KTI	BRONCHOSCOPE ACCESSORY
Bronchoscopes	EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)
Cables	DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Carbon Dioxide Absorbent	CBL	ABSORBENT, CARBON-DIOXIDE
Cardiac Enzymes	MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT
Cardiopulmonary Bypass-related Devices	DRY	MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
	DTL	ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
	DTM	FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
	DTN	RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
	DTP	DEFOAMER, CARDIOPULMONARY BYPASS
	DTQ	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
	DTR	HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
	DTS	SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
	DTW	MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
	DTX	GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
	DTY	SENSOR, BLOOD-GAS, IN-LINE, CARDIOPULMONARY BYPASS
	DTZ	OXYGENATOR, CARDIOPULMONARY BYPASS
	DWA	CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
	DWB	PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
	DWC	CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
	DWD	SUCTION CONTROL, INTRACARDIAC, CARDIOPULMONARY BYPASS
	DWE	TUBING, PUMP, CARDIOPULMONARY BYPASS
	DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
	DXS	GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS
	JOD	FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS
	KFM	PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
	KRJ	FILTER, PREBYPASS, CARDIOPULMONARY BYPASS
	KRL	DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS
	MJJ	CPB CHECK VALVE, RETROGRADE FLOW, IN-LINE
	MNJ	VALVE, PRESSURE RELIEF, CARDIOPULMONARY BYPASS
Catheters & Ports	DQX	WIRE, GUIDE, CATHETER
	DQY	CATHETER, PERCUTANEOUS
	FOS	CATHETER, UMBILICAL ARTERY
	FOZ	CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
	LFK	CATHETER, FEMORAL
	LIT	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
	LJT	PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
	LOX	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
	PND	MIDLINE CATHETER
Cautery Devices	GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Cerebrospinal Fluid (CSF) Shunts and Drains	GBS	CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY
	JXG	SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Clip Appliers	GDO	APPLIER, SURGICAL, CLIP
	HBT	APPLIER, HEMOSTATIC CLIP
Clips	MCH	CLIP, HEMOSTATIC
Coagulation Tests	GFO	ACTIVATED PARTIAL THROMBOPLASTIN
	GGW	TEST, TIME, PARTIAL THROMBOPLASTIN
	JBP	ACTIVATED WHOLE BLOOD CLOTTING TIME
Complete Metabolic Panel (CMP) Tests	CDQ	UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
	CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN
	CEJ	TETRAPHENYL BORATE, COLORIMETRY, POTASSIUM
	CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
	CFR	HEXOKINASE, GLUCOSE
	CGA	GLUCOSE OXIDASE, GLUCOSE
	CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
	CGX	ALKALINE PICRATE, COLORIMETRY, CREATININE
	CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
	CHG	ACID, PHOSPHORIC-TUNGSTIC (SPECTROPHOTOMETRIC), CHLORIDE
	CHJ	MERCURIC THIOCYANATE, COLORIMETRY, CHLORIDE
	CHS	COULOMETRIC METHOD, CARBON-DIOXIDE
	CIC	CRESOLPHTHALEIN COMPLEXONE, CALCIUM
	CIG	DIAZO COLORIMETRY, BILIRUBIN
	CIQ	DIAZO, AST/SGOT
	CIS	HYDRAZONE COLORIMETRY, AST/SGOT
	CIT	NADH OXIDATION/NAD REDUCTION, AST/SGOT
	CJY	AZO DYE, CALCIUM
	CKA	NADH OXIDATION/NAD REDUCTION, ALT/SGPT
	JFM	ENZYMATIC METHOD, BILIRUBIN
	JFP	ELECTRODE, ION SPECIFIC, CALCIUM
	JFY	ENZYMATIC METHOD, CREATININE
	JGS	ELECTRODE, ION SPECIFIC, SODIUM
	KHS	ENZYMATIC, CARBON-DIOXIDE
	LFR	GLUCOSE DEHYDROGENASE, GLUCOSE
	MZU	SYSTEM, TEST, SODIUM, ENZYMATIC METHOD
	MZV	TEST, SYSTEM, POTASSIUM, ENZYMATIC METHOD
Computed Tomography (CT) Scan	JAK	SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Condensers	BYD	CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Dialysate Tubing	FID	TUBING, DIALYSATE
Dialyzers	FJI	DIALYZER, CAPILLARY, HOLLOW FIBER
	KDI	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Disinfection & Pasteurization	LDS	DEVICE, PASTEURIZATION, HOT WATER
	LRJ	DISINFECTANT, MEDICAL DEVICES
	MEC	DISINFECTOR, MEDICAL DEVICES
	PSW	HIGH LEVEL DISINFECTION REPROCESSING INSTRUMENT FOR ULTRASONIC TRANSDUCERS, LIQUID
Dural Substitutes	GXQ	DURA SUBSTITUTE
	NQR	SEALANT, DURAL
Electrocardiogram (ECG) System	DPS	ELECTROCARDIOGRAPH
	DRX	ELECTRODE, ELECTROCARDIOGRAPH
Endoscopes & Accessory Devices	FEB	ACCESSORIES, CLEANING, FOR ENDOSCOPE
	KNS	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
	ODG	ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
Endotracheal Tubes (ETTs)	BSK	CUFF, TRACHEAL TUBE, INFLATABLE
	BTR	TUBE, TRACHEAL (W/WO CONNECTOR)
Endovascular Graft Systems	MIH	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
	QSK	HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT
Enteral Infusion Pumps	LZH	PUMP, INFUSION, ENTERAL
Extracorporeal Carbon Dioxide Removal System	QOH	EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL
Extracorporeal Membrane Oxygenation (ECMO) Cannulas, System, and Blood Pump	LLB	SYSTEM, BLOOD, EXTRACORPOREAL AND ACCESSORIES
	PZS	DUAL LUMEN ECMO CANNULA
	QHW	SINGLE LUMEN ECMO CANNULA
	QJZ	EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE
	QNR	BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE
Fetal Bladder Stents	MPR	STENT, BLADDER, FETAL
Fetal Monitors	HGM	SYSTEM, MONITORING, PERINATAL
Filters	CAH	FILTER, BACTERIAL, BREATHING-CIRCUIT
Flowmeters	CAX	FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
Fluid Warmers	LGZ	WARMER, THERMAL, INFUSION FLUID
Gas Analyzers	CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
	CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
Gas Mixers	BZR	MIXER, BREATHING GASES, ANESTHESIA INHALATION
Gastrointestinal (GI) Stents	MQR	STENT, COLONIC, METALLIC, EXPANDABLE
	MUM	STENT, METALLIC, EXPANDABLE, DUODENAL
Gastrointestinal (GI) Tubes	BSS	TUBE, NASOGASTRIC
	FEG	TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
	KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)
	PIF	GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Gauze/Sponge	NAB	GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE
Glucose Sensors	MDS	SENSOR, GLUCOSE, INVASIVE
	PQF	SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE
	PZE	SENSOR, GLUCOSE, INVASIVE, NON-ADJUNCTIVE, FACTORY-CALIBRATED, USER-INITIATED
Hemodialysis Catheter End Caps	PEH	HEMODIALYSIS CATHETER LUER END CAP
Hemodialysis Catheters	MPB	CATHETER, HEMODIALYSIS, NON-IMPLANTED
	MSD	CATHETER, HEMODIALYSIS, IMPLANTED
Hemodialysis Circuit Accessories	KOC	ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
Hemodialysis Dialysate	KPO	DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Hemodialysis Dialysate Delivery Systems	FIL	SYSTEM, DIALYSATE DELIVERY, SINGLE PASS
	FKP	SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT
Hemostatic Agents	LMF	AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
	PMX	ABSORBABLE COLLAGEN HEMOSTATIC AGENT WITH THROMBIN
High-Flow Oxygen Delivery Devices	QAV	HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
Humidifiers	BTT	HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Infant Warming Devices	FMT	WARMER, INFANT RADIANT
Infusion Filters	FPB	FILTER, INFUSION LINE
Infusion Pumps	FRN	PUMP, INFUSION
Insulin Infusion Pumps	LZG	PUMP, INFUSION, INSULIN
	OYC	PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
	QFG	ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
Intra-Aortic Balloon Pump (IABP) System	DSP	SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Intracranial Pressure Monitors	GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE
Intrauterine Tamponade Balloon	OQY	INTRAUTERINE TAMPONADE BALLOON
Intravenous (IV) Containers	KPE	CONTAINER, I.V.
Intravenous (IV) Stopcocks	FMG	STOPCOCK, I.V. SET
Kidney Perfusion Systems	KDN	SYSTEM, PERFUSION, KIDNEY
Lactate Dehydrogenase	CFJ	NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
	KHP	ACID, LACTIC, ENZYMATIC METHOD
Lancets	FMK	SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
Laryngoscopes	CCW	LARYNGOSCOPE, RIGID
Ligators	MND	LIGATOR, ESOPHAGEAL
Magnesium	CFA	ELECTRODE, ION SPECIFIC, MAGNESIUM
	CFO	TITRIMETRIC, MAGNESIUM
	JGJ	PHOTOMETRIC METHOD, MAGNESIUM
Manual Resuscitators	NHK	RESUSCITATOR, MANUAL, NON SELF-INFLATING
Mechanical Ventilators	BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
	CBK	VENTILATOR, CONTINUOUS, FACILITY USE
	LSZ	VENTILATOR, HIGH FREQUENCY
	MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
	MNT	VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
	QBY	POSITIVE AIRWAY PRESSURE SYSTEM
Media Culture	JTZ	CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
Nasal Cannulas	BZB	CATHETER, NASAL, OXYGEN
	CAT	CANNULA, NASAL, OXYGEN
Nasopharyngeal Airways	BTQ	AIRWAY, NASOPHARYNGEAL
Nebulizers	CAF	NEBULIZER (DIRECT PATIENT INTERFACE)
Needles	FMI	NEEDLE, HYPODERMIC, SINGLE LUMEN
	PTI	NON-CORING (HUBER) NEEDLE
	QNS	LOW DEAD SPACE NEEDLE, SINGLE LUMEN, HYPODERMIC
Neurosurgical Instruments	HAO	INSTRUMENT, SURGICAL, NON-POWERED
	HBE	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
	HBL	HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
	HCH	CLIP, ANEURYSM
	HCI	APPLIER, ANEURYSM CLIP
	MAX	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
	NKB	THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
	ODP	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
Neurovascular Embolization Devices	HCG	DEVICE, NEUROVASCULAR EMBOLIZATION
Non-Sterile Personal Protective Equipment (PPE)	FYC	GOWN, ISOLATION, SURGICAL
	FXX	MASK, SURGICAL
	LYY	LATEX PATIENT EXAMINATION GLOVE
	LYZ	VINYL PATIENT EXAMINATION GLOVE
	LZA	POLYMER PATIENT EXAMINATION GLOVE
	MSH	RESPIRATOR, SURGICAL
Nucleic Acid Amplification Test System	OOI	REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
Operating Room (OR) Suction Apparatus	GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Oropharyngeal Airways	CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
Orthoses	IQF	ORTHOSIS, CERVICAL-THORACIC, RIGID
	IQK	ORTHOSIS, CERVICAL
Oximeters	DQA	OXIMETER
	QEM	CEREBRAL OXIMETER
Oxygen Masks	BYG	MASK, OXYGEN
	KGB	MASK, OXYGEN, NON-REBREATHING
Oxygenator	BYS	OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS
Percutaneous Catheterization Dilators	DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
Peritoneal Dialysate Delivery Systems	KPF	SYSTEM, DIALYSATE DELIVERY, SEMI-AUTOMATIC, PERITONEAL
Peritoneal Dialysis Catheters	FJS	CATHETER, PERITONEAL, LONG-TERM INDWELLING
	FKO	CATHETER, PERITONEAL DIALYSIS, SINGLE USE
Physiological Monitors	MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Plain X-ray Systems	IZL	SYSTEM, X-RAY, MOBILE
	KPR	SYSTEM, X-RAY, STATIONARY
Portable Oxygen Sources	BYJ	UNIT, LIQUID-OXYGEN, PORTABLE
	CAW	GENERATOR, OXYGEN, PORTABLE
Positive End Expiratory Pressure (PEEP) Attachments	BYE	ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
Public Use Respirators	NZJ	RESPIRATOR, N95, FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MEDICAL EMERGENCIES
Specimen Collection Devices	FMH	CONTAINER, SPECIMEN, STERILE
	GIM	TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
	JKA	TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
	KDQ	BOTTLE, COLLECTION, VACUUM
	KDW	CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE
	PJC	NEWBORN SCREENING SPECIMEN COLLECTION PAPER
	PJE	BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING
Spinal Catheters	MAJ	CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
Spinal Needles	MIA	NEEDLE, SPINAL, SHORT TERM
Stents	NIM	STENT, CAROTID
	NIQ	CORONARY DRUG-ELUTING STENT
	NIV	CORONARY COVERED STENT
	PNF	AORTIC STENT
Sterilization	FLE	STERILIZER, STEAM
	FLF	STERILIZER, ETHYLENE-OXIDE GAS
	FRG	WRAP, STERILIZATION
	KMH	STERILIZER, DRY HEAT
	MED	STERILANT, MEDICAL DEVICES
	MLR	STERILIZER, CHEMICAL
Stretchers	FPO	STRETCHER, WHEELED
Stylets and Endotracheal Tube (ETT) Changers	BSR	STYLET, TRACHEAL TUBE
	LNZ	CHANGER, TUBE, ENDOTRACHEAL
Suction Tubes and Catheters	BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL
	BYY	TUBE, ASPIRATING, FLEXIBLE, CONNECTING
	DWM	APPARATUS, SUCTION, PATIENT CARE
	JOL	CATHETER AND TIP, SUCTION
	KCB	TUBE, TONSIL SUCTION
Surgical Drapes	PUI	DRAPE, SURGICAL, EXEMPT
Surgical Personal Protective Equipment (PPE)	FYA	GOWN, SURGICAL
	KGO	SURGEON'S GLOVES
Sutures	GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
	GAP	SUTURE, NONABSORBABLE, SILK
Syringes	FMF	SYRINGE, PISTON
	MEG	SYRINGE, ANTISTICK
	QNQ	LOW DEAD SPACE PISTON SYRINGE
Tape and Adhesive Bandages	KGX	TAPE AND BANDAGE, ADHESIVE
Thermoregulatory Devices	DWJ	SYSTEM, THERMAL REGULATING
Thermoregulatory Monitors	FLL	THERMOMETER, ELECTRONIC, CLINICAL
Thrombus Retriever Catheters	NRY	CATHETER, THROMBUS RETRIEVER
Tissue Adhesive for Embolization	KGG	TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
Tourniquets	GAX	TOURNIQUET, NONPNEUMATIC
Tracheostomy Tubes	BTO	TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
	JOH	TUBE TRACHEOSTOMY AND TUBE CUFF
Transfusion and Plasmapheresis Devices	CAC	APPARATUS, AUTOTRANSFUSION
	LKN	SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
Transport Medium	JSM	CULTURE MEDIA, NON-PROPAGATING TRANSPORT
Tubing	FPK	TUBING, FLUID DELIVERY
Ultrasound Systems and Accessory Devices	ITX	TRANSDUCER, ULTRASONIC, DIAGNOSTIC
	IYN	SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
	IYO	SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
	MUI	MEDIA, COUPLING, ULTRASOUND
Urinary Catheters and Related Devices	EZL	CATHETER, RETENTION TYPE, BALLOON
	FCN	URINARY DRAINAGE COLLECTION KIT, FOR INDWELLING CATHETER
Valves	CBP	VALVE, NON-REBREATHING
Ventricular Assist Devices (VADs)	OZD	TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
	PYX	TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
Wound Dressings	FRO	DRESSING, WOUND, DRUG
	MGR	DRESSING, WOUND AND BURN, INTERACTIVE
	NAC	DRESSING, WOUND, HYDROPHILIC
	NAD	DRESSING, WOUND, OCCLUSIVE

Submit feedback on the draft guidance, including the 506J Device List, using docket number FDA-2022-D-0053 at https://www.regulations.gov by February 15, 2024. Submission by this date will ensure the FDA is able to consider your comments on this draft guidance before it begins work on the final version of the guidance.  All docket comments should be identified with the docket number FDA-2022-D-0053 and complete title of the guidance.

For More Information

If you have questions or require additional information, please contact: CDRHManufacturerShortage@fda.hhs.gov.