Regulatory Focus™ > News Articles > UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked

UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked

Posted 28 March 2014 | By Alexander Gaffney, RAC 

A new guidance document released by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) updates the agency's list of devices that manufacturers are required to track by law.

Background

In 1997, the Food and Drug Administration and Modernization Act (FDAMA) was signed into law. Among the law's numerous requirements is one that manufacturers track specified devices at the order of FDA.

The statute, codified in the Federal Food, Drug and Cosmetic Act (FD&C Act) at 21 USC 360i(e) states:

(1) The Secretary [of FDA] may by order require a manufacturer to adopt a method of tracking a class II or class III device-

(A) the failure of which would be reasonably likely to have serious adverse health consequences; or

(B) which is-

(i) intended to be implanted in the human body for more than one year, or

(ii) a life sustaining or life supporting device used outside a device user facility.

(2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.

At the time, the authority was crucial to FDA, as it allowed it to better facilitate recalls and notifications in the event that a device was found to be dangerous and needed to be removed from the market.

How Are Determinations Made?

Those products are determined at FDA's discretion, but the agency says it uses three primary criteria to determine if a device must be tracked:

  • likelihood of sudden, catastrophic failure
  • likelihood of significant adverse clinical outcome
  • the need for prompt professional intervention

"The agency may add or remove devices from the list of tracked devices and may consider the additional guidance factors in conjunction with the review of premarket applications, recall data, medical device reporting, inspections, petitions, postmarket surveillance or other information coming to its attention," it explains in its latest guidance, Medical Device Tracking.

Information on what data must be tracked is available at 21 CFR 821.

UDI Coming Soon, But in the Meantime…

While FDA has since adopted its Unique Device Identification (UDI) rule, which will require tracking capabilities be instituted for nearly all devices, those requirements will not be finalized for some devices for several years.

In the meantime, FDA has updated the list of devices whose manufacturers will need to continue to track their products.

Preferred NameProcode
Aortic valve prosthesis, percutaneously delivered NPT
Breast prosthesis, non-inflatable, internal, silicone gel filledFTR
Defibrillator, axillary power supply (AC OR DC) for low energy DC defibrillatorMPD
Defibrillator, automated, external, wearableMVK
Defibrillator, automatic, implantable, cardioverter, with cardiac resynchronization (CRT-D)NIK
Defibrillator, DC, high energy (including paddles)DRK
Defibrillator, DC, low energy (including paddles)LDD
Defibrillator, implantable cardioverter (NON-CRT)LWS
Defibrillator, implantable, dual chamberMRM
Defibrillator, over-the-counter, automated, externalNSA
Defibrillators, automated external (AEDs) (non-wearable)MKJ
Electrode, pacemaker, permanentDTB
Electrode, pacing and cardioversion, temporary, epicardial NHW
Electrodes, defibrillator, permanentNVY
Electrodes, pacemaker, drug-eluting, permanent, right ventricular (RV) or right atrial (RA)NVN
Endovascular graft system, aortic aneurysm treatmentMIH
Heart valve, mechanicalLWQ
Heart valve, non-allograft tissueLWR
Heart valve, replacementDYE
Mandibular prosthesis, condyle, temporaryNEI
Monitor, apnea, home useNPF
Monitor, breathing frequencyBZQ
Pacemaker batteryDSZ
Pacemaker, lead adapterDTD
Pacemaker, pulse generator (NON-CRT) implantableLWP
Pacemaker, pulse generator, implantableDXY
Pulmonary valve prosthesis, percutaneously deliveredNPV
Pulmonic valve conduitMWH
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)NKE
Pulse generator, permanent, implantable NVZ
Pulse generator, single chamber, singleLWW
Pulse generator, dual chamber, pacemaker, externalOVJ
Pulse generator, single chamber, sensor driven, implantableLWO
Pump, infusion or syringe, extra-luminalFIH
Pump, infusion, implanted, programmableLKK
Shunt, protosystemic, endoprosthesisMIR
Stimulator, autonomic nerve, implanted (depression)MUZ
Stimulator, cerebellar, implantedGZA
Stimulator, diaphragmatic/ phrenic nerve, implantedGZE
Stimulator, diaphragmatic/phrenic nerve, laparoscopically implantedOIR
Stimulator, electrical, implanted, for Parkinsonian symptomsNHL
Temporomandibular joint, implantLZD
Transmandibular implantMDL
Ventilator, continuous, home useNOU
Ventilator, continuous, non-life-supportingNMS
Ventilator, continuous, minimal ventilatory support, facility useNMT
Ventilator, continuous, minimal ventilatory support, home useNQY
Ventilator, mechanicalONZ

The guidance also contains an extensive question and answer section detailing some of the more specific requirements of the device tracking program, such as specific tracking methods, outsourcing tracking, auditing requirements and the use of medical device registries.

Medical Device Tracking Guidance (FR) 


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