美國510K醫材上市申請委辦流程

美國FDA 510(K) 申請

服務項目

「醫療器材申請美國FDA 510(K)」輔導委託計畫。

服務內容

1. 技術諮詢。

2. 新技術文件處理及撰寫。

3. 輔導製造廠進行原料或產品測試並結果紀錄。

4. 測試過程中發生疑難或窒礙難行時，針對事實現況提出改善對策。

5. 美國FDA 510(K) 送件行政程序全程輔導。

6. 審查過程代表申請人與510(K)審查單位進行溝通。

服務流程說明

委託流程 說明

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm618561.htm#quik

美國FDA 510K執行流程

510(k) Program Pilots

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.

• Quality in 510(k) Review Program Pilot
• Special 510(k) Program Pilot

Quality in 510(k) Review Program Pilot

On September, 6, 2018, the FDA launched the Quality in 510(k) Review Program to provide an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission. 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. 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 criteria for the Quality in 510(k) Review Program Pilot?

A device must meet all of the following criteria to be eligible for participation in the Quality in 510(k) Review Program pilot:

1. The device's primary product code is listed below.
2. The device is not a combination product (such as a drug-device or biologic-device combination).
3. The lead Center for the device is the FDA's Center for Devices and Radiological Health (CDRH).
4. 4. The submission was constructed with the eSubmitter template "CDRH: Non-In Vitro Diagnostic Device - 510(k)."

If any of the above criteria 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 criteria, 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 template entitled "CDRH: Non-In Vitro Diagnostic Device - 510(k)." Submitters should not use the "In Vitro Diagnostic Device - 510(k)" template.

The eSubmitter template 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 installating 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.

eSubmitter Template Icons

Expert View: If you click the Expert button in the top left of the eSubmitter application, you can view the structure of the template.

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 the eSubmitter template, 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 the template will allow you 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 template, 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 of the template (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.

The following product codes are eligible for the Quality in 510(k) Review Program Pilot:

Regulation Product code Description
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
874.1050 Audiometer EWO Audiometer
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 LXQ Cup, Eye
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 esubmitter@fda.hhs.gov.

If you find any malfunctions or errors, or would like to provide feedback about the use of the eSubmitter template, please contact eSubPilot@fda.hhs.gov.

If you have questions regarding the eSubmitter template, 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.

Special 510(k) Program Pilot

The Special 510(k) Program is an existing optional regulatory pathway that simplifies the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles.

On October 1, 2018, the FDA launched the Special 510(k) Program Pilot, which aims to expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. The Special 510(k) Program Pilot provides industry and the FDA staff the opportunity to test this expansion to the existing Special 510(k) Program.

As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices.

What are the eligibility factors for participation in the Special 510(k) Program Pilot?

To be eligible to participate in the Special 510(k) Program Pilot, the following factors should be met for the 510(k):

1. The proposed change is made and submitted by the manufacturer authorized to market the existing device,
2. Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and
3. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

This pilot is limited to Special 510(k)s for which the lead Center is the Center to Devices and Radiological Health (CDRH).

All Special 510(k)s submitted to CDRH will be considered as part of the pilot. Manufacturers should continue to identify their submission as a Special 510(k). This pilot is intended to clarify and expand the current Special 510(k) Program.

How to prepare a Special 510(k) for this pilot?

Please see the How To Prepare A Special 510(k) page for more information. The recommended content for a Special 510(k) has not changed as part of this pilot.

Note: If your submission is found inappropriate to remain a Special 510(k), you will be notified via email that your submission will be reviewed as a Traditional 510(k).

How to submit a Special 510(k) for this pilot?

Send a valid eCopy 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.

What are the MDUFA User Fees for Special 510(k)s under this pilot?

510(k)s submitted as part of the Special 510(k) 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?

Subject to the FDA's acceptance review in accordance with the guidance "Refuse to Accept Policy for 510(k)s," the FDA intends to process a Special 510(k) submissions within 30 days of receipt.

The FDA may still convert a Special 510(k) Program Pilot submission to a Traditional 510(k) if:

• The 510(k) is submitted for a change that is not to the manufacturer's own existing device;
• Testing is needed to evaluate the change and there is no well-established method to evaluate the change; or
• The data cannot be reviewed in a summary or risk analysis format.

Whom do I contact if I have questions?

For more information about the Special 510(k) 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.

Additional Resources

• Webinar- Special 510(k) Program Pilot - November 8, 2018