New FDA Pilot Program for 510(k) "Quik" Review
FDA has launched a new pilot program for a “Quick Review“ of 510(k) of certain medical devices, by using the eSubmitter software to format the submission. The devices that qualify for this quick review, as shown on list below, are moderate risk devices that are considered to be well-understood by the FDA. With the quick review program, 510(K)s are reviewed by FDA in 60 days instead of 90 days.
What are the eligibility criteria?
- The device’s primary product code is listed below.
- The device is not a combination product (such as a drug-device or biologic-device combination).
- The lead Center for the device is the FDA’s Center for Devices and Radiological Health (CDRH).
- The submission was constructed with the eSubmitter template “non-In Vitro Diagnostic Device – 510(k).”
How to prepare a 510(k) for the Quick Review Program?
510(k)s submitted as part of the Quick Review Program pilot must be constructed using the eSubmitter template entitled “CDRH: Non-In Vitro Diagnostic Device – 510(k).”
The eSubmitter asks for the same information typically requested in a Traditional 510(k). After it is constructed, the eSubmitter will format the submission into a ZIP file. This should be copied to a CD, DVD, or USB drive.
The cover letter of the 510(k) should state that the submission id part of the Quick Review Program Pilot. Otherwise, it will be received as a traditional 510(k).
What are the Review Timeline and Fees?
For 510(k)s submitted as part of the Quick Review Program, the refuse to accept (RTA) review is not conducted and the final decision for the 510(k)s is made by the FDA within 60 days of receipt.
510(k)s submitted as part of the Quick Review Program pilot are subject to the same user fees than a traditional 510(k). For the current User Fee amounts, please see MDUFA User Fees.
The list of eligible devices with their product codes :
|880.2910 Clinical electronic thermometer||FLL||Electronic thermometer|
|880.557 Hypodermic single lumen needle||FMI||Hypodermic single lumen needle|
|870.1875 Stethoscope||DQD||Electronic Stethoscope|
|870.1250 Percutaneous catheter||DQY||Percutaneous Catheter|
|870.1310 Vessel dilator for percutaneous catheterization||DRE||Vessel Dilators|
|870.2900 Patient transducer and electrode cable (including connector)||DSA||Cable, Transducer And Electrode, Patient, (Including Connector)|
|870.4450 Vascular clamp||DXC||Vascular Clamps|
|870.1650 Angiographic injector and syringe||DXT||Angiographic Syringes|
|870.1340 Catheter introducer||DYB||Catheter Introducer|
|870.5800 Compressible limb sleeve||JOW||Compressible limb sleeve|
|870.1650 Angiographic injector and syringe||MAV||Syringe, Balloon Inflation|
|870.4885 External vein stripper||MGZ||Valvutome|
|882.1320 Cutaneous electrode||GXY||Cutaneous electrode|
|890.3850 Mechanical wheelchair||IOR||Mechanical wheelchair|
|890.5650 Powered inflatable tube massager||IRP||Massager, powered inflatable tube|
|888.3030 Single/multiple component metallic bone fixation appliances and accessories||LRN||Surgical wire|
|888.3030 Single/multiple component metallic bone fixation appliances and accessories||LYT||Fixation accessory|
|888.3050 Spinal interlaminal fixation orthosis||NQW||Orthosis, Spine, Plate, Laminoplasty, Metal|
|886.1850 AC-powered slitlamp biomicroscope||HJO||Biomicroscope, Slit-Lamp, Ac-Powered|
|886.1120 Ophthalmic camera||HKI||Ophthalmic camera, AC powered|
|886.1780 Retinoscope||HKL||Retinoscope, Ac-Powered|
|886.4370 Keratome||HMY||Keratome, Battery-Powered|
|886.4370 Keratome||HNO||Keratome, Ac-Powered|
|886.4670 Phacofragmentation system||HQC||Unit, Phacofragmentation|
|874.3400 Tinnitus masker||KLW||Tinnitus masker|
|886.5928 Soft (hydrophilic) contact lens care products||LRX||Case, Contact Lens|
|Unclassified||OKS||Lacrimal Stents and Intubation Sets|
|876.4500 Mechanical lithotripter||FGK||Tripsor, stone, bladder|
|876.1500 Endoscope and accessories||FTI||Lamp, endoscope, incandescent|
|876.1500 Endoscope and accessories||OCZ||Endoscopic grasping/cutting instrument, non-powered|
|876.1500 Endoscope and accessories||GCJ||Laparoscope, General & Plastic Surgery|
|878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology||GEX||Powered laser surgical instrument|
|890.5500 Infrared lamp||OAP||Laser, comb, hair|
|892.1000 Magnetic resonance diagnostic device||MOS||Coil, magnetic resonance, specialty|
|892.1680 Stationary x-ray system||MQB||Solid state x-ray imager (flat panel/digital imager|
|892.2050 Picture archiving and communications system||PGY||Display, diagnostic radiology|
If you have questions about your eligibility for this Quick Review Program Pilot, or need help in the preparation and submission of the 510(k) using the eSubmitter, please contact Global Regulatory Partners at firstname.lastname@example.org and we will get back to within 24 hours.