UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked
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 Name | Procode |
|---|---|
| Aortic valve prosthesis, percutaneously delivered | NPT |
| Breast prosthesis, non-inflatable, internal, silicone gel filled | FTR |
| Defibrillator, axillary power supply (AC OR DC) for low energy DC defibrillator | MPD |
| Defibrillator, automated, external, wearable | MVK |
| 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 chamber | MRM |
| Defibrillator, over-the-counter, automated, external | NSA |
| Defibrillators, automated external (AEDs) (non-wearable) | MKJ |
| Electrode, pacemaker, permanent | DTB |
| Electrode, pacing and cardioversion, temporary, epicardial | NHW |
| Electrodes, defibrillator, permanent | NVY |
| Electrodes, pacemaker, drug-eluting, permanent, right ventricular (RV) or right atrial (RA) | NVN |
| Endovascular graft system, aortic aneurysm treatment | MIH |
| Heart valve, mechanical | LWQ |
| Heart valve, non-allograft tissue | LWR |
| Heart valve, replacement | DYE |
| Mandibular prosthesis, condyle, temporary | NEI |
| Monitor, apnea, home use | NPF |
| Monitor, breathing frequency | BZQ |
| Pacemaker battery | DSZ |
| Pacemaker, lead adapter | DTD |
| Pacemaker, pulse generator (NON-CRT) implantable | LWP |
| Pacemaker, pulse generator, implantable | DXY |
| Pulmonary valve prosthesis, percutaneously delivered | NPV |
| Pulmonic valve conduit | MWH |
| Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) | NKE |
| Pulse generator, permanent, implantable | NVZ |
| Pulse generator, single chamber, single | LWW |
| Pulse generator, dual chamber, pacemaker, external | OVJ |
| Pulse generator, single chamber, sensor driven, implantable | LWO |
| Pump, infusion or syringe, extra-luminal | FIH |
| Pump, infusion, implanted, programmable | LKK |
| Shunt, protosystemic, endoprosthesis | MIR |
| Stimulator, autonomic nerve, implanted (depression) | MUZ |
| Stimulator, cerebellar, implanted | GZA |
| Stimulator, diaphragmatic/ phrenic nerve, implanted | GZE |
| Stimulator, diaphragmatic/phrenic nerve, laparoscopically implanted | OIR |
| Stimulator, electrical, implanted, for Parkinsonian symptoms | NHL |
| Temporomandibular joint, implant | LZD |
| Transmandibular implant | MDL |
| Ventilator, continuous, home use | NOU |
| Ventilator, continuous, non-life-supporting | NMS |
| Ventilator, continuous, minimal ventilatory support, facility use | NMT |
| Ventilator, continuous, minimal ventilatory support, home use | NQY |
| Ventilator, mechanical | ONZ |
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)