Caution about FDA’s Most Recent UDI “Enforcement Discretion” Guidance

On 1 July 2020, the FDA updated a 2018 guidance document, extending the period in which they would exercise “enforcement discretion” for the UDI requirement (standardized date formatting, UDI labeling, and GUDID data submission requirements) for certain class I and unclassified devices to 24 September 2022.

This guidance, as with the 2018 version, does not change the compliance date – it remains 24 September 2018.  FDA is intending to not enforce the UDI requirements for these device types. This is important, as it affects, for example the 3-year existing inventory exception, which remains 24 September 2021.

However, it is important to note that this guidance does not apply to those devices that are considered implants or Life-Supporting/Life-Sustaining (LS/LS). Moreover, this last UDI compliance date is for both class I devices and those “…devices that have not been classified into class I, class II, or class III.” This last group actually encompasses 2 distinct groups – unclassified and not classified devices. Therefore, we have to look carefully for any device that is an implant and/or Life-Supporting/Life-Sustaining – and is either a class I, unclassified, or not classified device. This also applies to any convenience kit or combination product that contains one of these devices. Also, unlike the 2018 guidance, this guidance does not change the compliance date for the Direct Mark requirement – that is, it remains, as in the 2018 guidance, 24 September 2022. It should also be noted that, while GMP-exempt class I devices are exempt from UDI requirements, they are NOT exempt from the standardized date format requirements (§801.18). This was due 24 September 2018.

FDA assigns these implanted and LS/LS attributes based on product codes (procodes). A list of those devices types that are NOT subject to the “enforcement discretion” – and therefore must be fully UDI compliant (actually due 24 September 2015) is listed below:

Class 1 Implanted Device
PFO – active implantable bone conduction hearing system
DSW – bag, polymeric mesh, pacemaker
JDT – cap, bone
FKC – clamp, cannula

Unclassified Implanted Device
LFB – button, nasal septal
KGN – dressing, wound, collagen
LCJ – expander, skin, inflatable
PGM – growing rod system
PGN –growing rod system- magnetic actuation
OHA – heart valve, more than minimally manipulated allograft
NVR – intervertebral fusion device with bone graft, solid-sphere, lumbar
PHU – intra-abdominal pressure monitoring device
OKS – lacrimal stents and intubation sets
LLD – port & catheter, implanted, subcutaneous, intraperitoneal
MDI – prosthesis, rib replacement
LZJ – prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
LQS – spermatocele, alloplastic
MRW – system, facet screw spinal device
MTJ – wax, bone

Not Classified Implanted Device
PBU – bone void filler, syringe
NAP – cardiac support mesh wrap
PIX – elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis
QCG – filler, bone void, calcium compound, lower extremity use, use on bone marrow lesions
OYR – filler, bone void, recombinant platelet-derived growth factor
PFE – gastrointestinal liner system
PFM – hemibridge system
PCW – implantable pulse generator, programmer and battery charger
POI – lung tissue sealant for lung volume reduction
QGP – posterior ratcheting rod system
MQO – prosthetic disc nucleus device
PWG – spinal fixation system
PKK – stent delivery system
NGV – system, appendage closure, left atrial
QHP – vertebral body tethering system

Not Classified Life-Sustain/Support Device
QLN – extracorporeal system for carbon dioxide removal
OYR – filler, bone void, recombinant platelet-derived growth factor
QLO – immunoadsorption column for covid-19 use
MSK – immunoassay for blood tacrolimus