The FDA will periodically initiate pilot programs to help improve consistency and efficiency in 510(k) review. These pilot programs are intended to aid both industry and FDA staff in using resources effectively. This allows the FDA to direct more effort on the review of higher risk devices, which helps reduce total time to decision, and promotes consistency in 510(k) reviews. The programs do not alter the statutory threshold or data requirements for the determination of substantial equivalence.
The Quality in 510(k) Review Program Pilot provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission for certain device types. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered to be well-understood by the FDA. This means the FDA believes these products can be reviewed in an efficient manner while still maintaining safety and effectiveness through a substantial equivalence determination. The goal is for the FDA to make a final decision within 60 days of receipt of a 510(k) for an eligible device.
The purpose of the Quality in 510(k) Review Program pilot is to evaluate the Quality in 510(k) Review Program and whether use of the FDA's free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently to help promote timely access to safe, effective, and high-quality medical devices.
What are the eligibility factors for the Quality in 510(k) Review Program Pilot?
A device must meet all of the following factors to be eligible for participation in the Quality in 510(k) Review Program pilot:
- 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 "CDRH: Non-In Vitro Diagnostic Device - 510(k)."
If any of the above factors are not met, the submitter will have to submit the 510(k) using the traditional method of submitting a valid eCopy to the Document Control Center. If the submitter attempts to submit a 510(k) using the eSubmitter application for a product that does not meet the eligibility factors, it will be rejected for an invalid eCopy.
How to prepare a 510(k) for the Quality in 510(k) Review Program Pilot?
510(k)s submitted as part of the Quality in 510(k) Review Program pilot must be constructed using the eSubmitter software entitled "CDRH: Non-In Vitro Diagnostic Device - 510(k)." Submitters should not use "In Vitro Diagnostic Device - 510(k)".
eSubmitter asks for the same information typically requested in a Traditional 510(k). After it is constructed, the eSubmitter application will format the submission into a ZIP file (the eSubmission package). This should be copied to a CD, DVD, or USB drive.
IMPORTANT: A cover letter must be included with the following statement to distinguish it as being part of the Quality in 510(k) Review Program Pilot. If this statement is not included, the submission may not be accepted into the Quality in 510(k) Review Program pilot. If the document is not accepted in to the Quality in 510(k) Review Program, it will be processed as a Traditional 510(k) submission.
"This submission is part of the Quality in 510(k) Review Program Pilot, and is organized according to the standard eSubmitter output package. Accordingly, special eCopy processing applies. As per the agreement for the Quality in 510(k) Review Program Pilot, no full paper copies are required."
Instructions for downloading and installing the eSubmitter application are available at the eSubmitter Download and Installation website.
For further information on the eSubmitter Program, please see the CDRH eSubmitter Program section.
Expert View: If you click the Expert button in the top left of the eSubmitter application, you can view the structure of the information requested.
Folder icon: In Expert view, you can see whether a page is complete or incomplete by the presence of a check or question mark on each folder, respectively. eSubmitter will only allow you to package a submission when all folders have a check mark.
Yellow light bulbs: Help text is present for most of the questions in eSubmitter, and can be viewed by clicking the yellow light bulbs associated with each question.
Blue dots: Questions with a blue dot need to be answered before you will be allowed to package it into a ZIP file at the end.
How to submit a 510(k) to the Quality in 510(k) Review Program Pilot?
Send the submission to CDRH's Document Control Center. The current mailing address for CDRH's Document Control Center is provided on the eCopy Program for Medical Device Submissions webpage.
Note: Differences between eCopy and eSubmission
- An eSubmission package contains PDF attachments and XML file types. The XML files are intended for CDRH IT systems to process the application. Reviewers will not see these XML files.
- The parts of the eCopy guidance that describe the structure of a 510(k) submission will not apply to the Quality in 510(k) Review Program Pilot.
- An eSubmission is organized according to the layout of the information intake, which places administrative documents (e.g., Form 3674, the 510(k) Summary, the Truthful and Accurate statement) at the end of the submission because their applicability is determined based on the answers to questions in the body (e.g., Form 3674 is only required if the applicant indicates clinical data are included).
- Electronic signatures are used in the submission (e.g., on the Truthful and Accurate statement), rather than physical signatures.
To submit an amendment or supplement to the 510(k), please submit a valid electronic copy or eCopy to the Document Control Center, eSubmitter can not be used for an amendment or supplement.
What are the Quality in 510(k) Review MDUFA User Fees?
510(k)s submitted as part of the Quality in 510(k) Review Program pilot are subject to user fees. For the current User Fee amounts, please see MDUFA User Fees.
What is CDRH Review and the Review Timeline?
If the submission is eligible for the Quality in 510(k) Review Program pilot, the refuse to accept (RTA) review will not be conducted. The review is expected to be interactive. This means that the FDA does not plan to put the submission on hold for a request for Additional Information (AI). Instead, submitters are expected to respond quickly to FDA requests for additional information.
A final decision for 510(k)s received as part of the Quality in 510(k) Review Program pilot is intended to be made by the FDA within 60 days of receipt.
Note: If the 510(k) is found to be ineligible for the Quality in 510(k) Review Program pilot, the FDA will email the official contact of the 510(k) to inform them of this decision and the reason why a review cannot be completed within 60 days. Then the 510(k) will be reviewed according to standard procedures using the traditional 90-day timeframe.
|870.1250 Percutaneous catheter||DQY||Percutaneous Catheter
(only for cardiovascular and peripheral indications)
|870.1310 Vessel dilator for percutaneous catheterization||DRE||Vessel Dilators|
|870.1340 Catheter introducer||DYB||Catheter Introducer|
|870.1650 Angiographic injector and syringe||DXT||Angiographic Syringes|
|870.1650 Angiographic injector and syringe||MAV||Syringe, Balloon Inflation|
|870.1875 Stethoscope||DQD||Electronic Stethoscope|
|870.2900 Patient transducer and electrode cable (including connector)||DSA||Cable, Transducer And Electrode, Patient, (Including Connector)|
|870.4450 Vascular clamp||DXC||Vascular Clamps|
|870.4885 External vein stripper||MGZ||Valvutome|
|870.5800 Compressible limb sleeve||JOW||Compressible limb sleeve|
|874.3400 Tinnitus masker||KLW||Tinnitus masker|
|876.1500 Endoscope and accessories||FTI||Lamp, endoscope, incandescent|
|876.1500 Endoscope and accessories||GCJ||Laparoscope, General & Plastic Surgery|
|876.1500 Endoscope and accessories||OCZ||Endoscopic grasping/cutting instrument, non-powered|
|876.4500 Mechanical lithotripter||FGK||Tripsor, stone, bladder|
|878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology||GEX||Powered laser surgical instrument|
|880.2910 Clinical electronic thermometer||FLL||Electronic thermometer|
|880.5570 Hypodermic single lumen needle||FMI||Hypodermic single lumen needle|
|882.1320 Cutaneous electrode||GXY||Cutaneous electrode|
|886.1120 Ophthalmic camera||HKI||Ophthalmic camera, AC powered|
|886.1780 Retinoscope||HKL||Retinoscope, Ac-Powered|
|886.1850 AC-powered slitlamp biomicroscope||HJO||Biomicroscope, Slit-Lamp, Ac-Powered|
|886.4370 Keratome||HMY||Keratome, Battery-Powered|
|886.4370 Keratome||HNO||Keratome, Ac-Powered|
|886.4670 Phacofragmentation system||HQC||Unit, Phacofragmentation|
|886.5700 Eyelid weight||MML||Weights, Eyelid, External|
|886.5928 Soft (hydrophilic) contact lens care products||LRX||Case, Contact Lens|
|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|
|890.3850 Mechanical wheelchair||IOR||Mechanical wheelchair|
|890.5500 Infrared lamp||OAP||Laser, comb, hair|
|890.5650 Powered inflatable tube massager||IRP||Massager, powered inflatable tube|
|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|
|unclassified||OKS||Lacrimal Stents and Intubation Sets|
Whom do I contact if I have questions?
If you have questions about the use of the eSubmitter application, such as packaging a submission, please contact firstname.lastname@example.org.
If you find any malfunctions or errors, or would like to provide feedback about the use of eSubmitter, please contact eSubPilot@fda.hhs.gov.
If you have questions regarding eSubmitter, options, or the Quick Review Program pilot, please contact 510K_Program@fda.hhs.gov.
For general questions about medical devices, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 800-638-2041, or 301-796-7100.