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 :

Regulation Product code Description
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
874.1050 Audiometer EWO Audiometer
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 LXQ Cup, Eye
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 info@globalregulatorypartners.com and we will get back to within 24 hours.

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