US FDA 510k Number
US FDA 510k number is a premarket notification number provided by the FDA after a manufacturer or specification developer has demonstrated that the medical device is substantially equivalent in performance and safety to other devices already existing on the market. A 510k is not a premarket approval, neither establishment registration nor device listing. In three situations, an FDA 510k is usually needed.
- The first is if it’s the first time bringing a new device to the market.
- The second is to change the indications for the use of a previously approved product,
- The third is to make significant changes to a previously approved device.
In these circumstances, we would require a 510k, and you would need 510k approval before you could register, list, or begin marketing.
FDA 510k Approval Process
Once determined, the appropriate device classification then needs to find the substantial equivalent device. Substantial Equivalence essentially proves that the current device, compared to a reference device, has the same intended use and technical characteristics or has the same planned application. The technical variations do not pose any new concerns regarding safety and effectiveness.
An FDA 510k submission must for
- Domestic manufacturers are introducing a device to the U.S. market.
- Re-packer or Re-labeler who makes labeling changes or whose operations significantly affect the device.
- Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers /exporters are introducing a medical device to the U.S. market.
The 510k submission must be made.
- Anyone who wants to sell a device in the United States of America is required to make a 510k submission at least 90 days before offering the device for sale, even though it may have been under development or clinical investigation before that date.
- Change in the intended use for a device that you already have in commercial distribution. (Already cleared 510k submission process)
- If there is a change or modification of a legally marketed device, that change could significantly affect its safety or effectiveness.
- A new FDA 510k submission is required for changes or modifications to an existing device. The amendments could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use.
When bringing a medical device to market in the United States, based on the risk class and intended use of the device to determine whether to (a) submit a premarket notification, also known as 510k, or (b) petition for premarket approval (PMA) exempted device. While these three terms may sound similar, the amount of time, money, and documentation involved with each are entirely different.
All these complexities necessities the importance of appointing an FDA 510k consultant or agent for various types of 510k submissions.
Medical Device Classification
According to US FDA, the definition of Medical Device various slightly from MDD. The classification method and criteria also differ. The US FDA has established classifications for approximately 1,700 different generic types of devices and is categorized into 16 medical specialties. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:
Class I General Controls
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- With Exemptions
- Without Exemptions
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Class II General Controls and Special Controls
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- With Exemptions
- Without Exemptions
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Class III General Controls and Premarket Approval
Class 1 or 11 devices If not exempt, you need to select the 510k route for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR 862-892. A premarket approval application (PMA) will be required for Class III devices unless your device is a pre-amendments device or substantially equivalent to such a device, and PMA’s have not been called for. In that case, an FDA 510k will be the route to market.
The classification of a device is determined by its intended usage as well as its indications for use. Furthermore, classification is risk-based, which means that the risk posed by the system to the patient and/or the user is a significant factor in the class to which it is classified. Class I devices have the lowest risk, while Class III devices have the highest risk. All classes of devices are subject to General Controls, as mentioned above. The Food, Drug, and Cosmetic Act (FD&C Act) establish the minimum standards for all medical devices, including Class I, II, and III.
Find Device Class
Class of device can be identified from the database
The same can be used to find the following
- To find the class of your device
- To find any exemptions may exist 510k
- To find the Regulation Number
- To find out GMP is applicable or not
- To find out device description
- To find out 21 CFR Part Number
If you can identify the right product code before approaching us, we will speed up our advice with more accurate information.
FDA 510k Consultants
To ensure timely submission and clearances, an FDA 510k Consultant is highly recommended. We, as consultants typically assist with 510k preparation, review, US Agent, and answering FDA review comments. We have good QA and RA consultants with technical and scientific knowledge above 6 years. The process of FDA 510k submission is detailed below.
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- Initial GAP assessment of the medical device in the scope of 510k
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- Product analysis
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- Predicate finding
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- Product classification
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- Identify FDA guidance for the specific product
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- The requirement of performance data study
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- Prepare a technical comparison of your medical device to the predicate device(s).
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- Product description writing
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- Label review and modification
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- FDA 510k document preparation (we develop, edit, review 510k compiled the file. We will not allow the client to work on documentation)
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- Prepare all 21 sections of the FDA 510k application.
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- Coordinate for making payment of FDA 510k submission fees.
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- Submit the hard copy and eCopy to the CDRH division within the FDA
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- 510k follow-up with FDA officials and will be correspondent for further communications with the FDA.
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- Responses to requests for additional information in the shortest time frame.
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- For foreign exporters, we act as US Agents for your firm.
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- US Agent/Consultants Immediately communicate with you regarding all information received from the FDA following the FDA submission and assist in addressing requests for additional information, if applicable.
FDA will not perform any ONSITE inspection as part of FDA 510k clearance. The manufacturer should implement FDA Quality System (GMP) as per 21 CFR 820 and be ready to face inspection by FDA auditors at any time after marketing the devices in the USA.
Role of FDA 510(k) Consultant
The following are the significant steps involved in the preparation and submission of FDA 510(k)
Step 1: | Identify the device regulation number and device code. |
Step 2: | Discuss and debate with the client to identify the predicate /equivalent 510k cleared device. |
Step 3: | Identify 510k type a. Traditional 510(k) b. Abbreviated FDA 510(k) c. Special FDA 510(k). |
Step 4: | FDA 510k Preparation, along with preclinical studies and External testing. |
Step 5: | 510(k) Pre-submission to FDA. |
Step 6: | 510(k) updation as per FDA review comments. |
Step 7: | US Agent appointment and FDA review Fee payment. |
Step 8: | US FDA 510(k) submission ( Hard copy & E copy). |
Step 9: | Communicate and follow up with the FDA (on behalf of the client). |
Step 10: | FDA 510k modification and resubmission as per FDA review comment. |
Step 11: | Wait for additional review comments, if any, till receipt of the 510(k) number. |
Step 12: | Establishment Registration with 510(k) number and list the 510(k) cleared device. |
Step 13: | Initiate sales and marketing of the device in the USA. |
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A presentation about 510k process
Why Consultants for 510k Submission & Approval
PHASE I |
Stages |
Activity |
Responsibility |
Timeline |
1 |
Select the Medical Device and models for USFDA Approval |
CLIENT |
20 Days |
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2 |
Identify Predicate Device with same indication and technology |
CLIENT + MDC |
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3 |
If NOT substantially equivalent, follow PMA route or substantially equivalent follow 510k route |
CLIENT + MDC |
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4 |
Appoint MedDeviceCorp as Technical Consultants and US Agent for clearance |
CLIENT |
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PHASE II |
5 |
Identify device Code and Regulation Number along with verification of Predicate Device, indication & technology. |
MDC |
90 Days |
6 |
Identify the device Class and guidance document |
MDC |
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7 |
Biological evaluation and test requirement Identification in line with the predicate device |
MDC |
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8 |
Samples send to Laboratory |
CLIENT |
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9 |
Evaluation of equivalent device compilation |
MDC |
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10 |
Drafting of 510k file in line with available FDA guidance document. |
MDC |
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11 |
Review of Risk analysis, Equivalent device data, Biocompatibility Test / Safety test protocols |
CLIENT + MDC |
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12 |
Review of Labels, User Manual / IFU, Shelf-life records/lifetime calculation, and preclinical study evidence |
CLIENT +MDC |
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13 |
Pre-submission |
CLIENT + MDC |
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PHASE III |
14 |
Compilation by incorporating the pre-submission comments |
MDC |
90 Days |
15 |
Compilation of Preclinical and Biocompatibility / Safety testing |
MDC |
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16 |
Compilation and release of the Final Draft |
MDC |
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17 |
Review |
MDC |
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PHASE IV |
18 |
US Agent Appointment |
CLIENT |
20 Days |
19 |
Review payment |
CLIENT |
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20 |
Submission in Hard copy and E Copy |
MDC |
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21 |
Receipt of acknowledgement |
CLIENT |
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22 |
Wait for the review comments |
CLIENT |
90 Days | |
PHASE V |
23 |
Modify the 510(k) and provide additional supporting documentary evidence as per FDA review comments |
CLIENT + MDC |
60 Days |
24 |
Resubmission |
MDC |
10 Days | |
25 |
Wait for the review comments or 510(k)clearance letter |
CLIENT |
90 Days |
US FDA 510k Documentation & Submission Fees
(Consulting, 510k Preparation, Pre-submission, Final Submission & US Agent)
- US FDA Medical Device Establishment Registration FY 2023 Fees: $6493
- FDA 510k Review Fee FY-2023 (Standard): $19870
- FDA 510k Review Fee FY-2023 (Small Business): $4967
Clients may make the above payments directly to US FDA
OPTION 1: FDA 510k Complete Package Fees
Payable to MedDeviceCorp [Oct 2022 – Sep 2023]
Type of Device |
Guidance Fee |
510(k) (File) preparation |
Submission Fee |
Non-invasive |
8000 – 9000 USD |
6000 – 7000 USD |
500 USD |
Invasive |
10000 – 11000 USD |
8000 – 9000 USD |
500 USD |
Implant |
12000 – 13000 USD |
10000 – 11000 USD |
500 USD |
OPTION 2: FDA 510k Partial Service Fees
Payable to MedDeviceCorp [Oct 2022 – Sep 2023]
Activity |
Cost |
Remarks |
USFDA 510(k) detailed Review |
6500 – 8500 USD /510(k) |
Device Code, Regulation Number & Predicate device accurate information must be provided by the client. Timeline 30 working days |
USFDA 510(k) Quick Review + FDA Pre-Submission * |
6000-7500 USD/510(k) |
Expected timeline 90 to 120 days. US Agent Fees, File Conversion & Stationery / Courier charges included ( No payment needed for FDA) * 510(k) submission can be added to the above service with additional fees of 1500 USD |
USFDA 510(k) Pre-Submission |
3500 USD /510(k) |
US Agent Fees, File Conversion & Stationery / Courier charges included Expected timeline 90 days. ( No payment needed for FDA) |
USFDA 510(k) Pre-Submission + FDA 510k Submission |
6500 USD / 510(k) |
Expected Pre-Submission timeline 90 days Expected 510(k) Review timeline 120 days FDA Pre-Submission is free and 510(k) Submission FY review charges applicable US Agent Fees, File Conversion & Stationery / Courier charges included |
Important
- Country specific Government taxes additional.
- Consultant onsite visit based on customer request. Travelling and Boarding extra invoiced on actual.
- Project cost is divided into 4 instalments based on the progress of the project.
- Method of communication – Email / Telephone / Skype / WhatsApp.
- Language for communication – English.
- Complete documentation by Cloud server.
- 510k preparation timeline 60 to 90 days and Pre-submission approx. 90 days.
- Expected timeline for completing FDA multiple reviews and Clearance 140 – 180 working days.
Looking for a detailed estimate? Please fill up the Request for Quote and submit it online. Our Experts will study the information submitted and will revert back to you soon.
What you mean by proposed predicative device? Is it necessary to include in 510(k)?
Proposed predicate device refers to a lawfully marketed, 510(k) cleared product that is used to determine substantial equivalence of the proposed/new device for 510(k) Submission.
Yes, FDA submission is required because the 510(k) clearance is determined by the proposed device’s substantial equivalence to a legally marketed device. A comparison table and discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalence is an important aspect of the 510(k).
Do you have a ready to edit and use template for Acceptance Checklist for Abbreviated 510(k) Submission?
(1) TRADITIONAL >> https://www.i3cglobal.store/acceptance-checklist-for-traditional/
(2) ABBREVIATED >> https://www.i3cglobal.store/acceptance-checklist-abbreviated-510k/
(3) SPECIAL >> https://www.i3cglobal.store/acceptance-checklist-for-special-510ks/
Do you have a ready to edit and use template for 510(k) summary?
Yes. The parameters and the sections may vary based on the device requirements. Click to know more https://www.i3cglobal.store/templates/
What do you mean by Truthful and Accurate Statement? Is it a part of 510(k) File?
Truthful and Accurate Statements must be a part of all 510(k) submissions. In this section, the submitter gives a statement that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Is Summary and Certification a part of 510(k) File? Is it applicable for all devices?
Only class III devices that do not require a PMA submission should have a summary and certification, and they should be included in the 510(k) documentation. The Class III Summary is a list of issues related to the device’s safety and effectiveness.
It must provide a complete description of information on the item as well as other lawfully marketed devices, as well as citations to such data if applicable. I devised this part is not applicable for classes II and Class, and can insert the statement “This section does not apply” or “N/A” under that heading.
Buy read to use templates: https://www.i3cglobal.store/templates/
What is Declaration of Conformity? Is it part of FDA 510(k)?
The purpose of a declaration of conformity is to offer information on the use of voluntary consensus standards, such as any declarations of conformity or the rationale for their wide usage in traditional submissions. Whereas for short 510(k) submissions, a summary report that details how the device conforms with the special controls associated with the particular device type or that are indicated in any applicable device-specific guidelines is required.
For both regular and abbreviated 510(k) submissions, the declaration of conformance section is appropriate. Buy read to use templates: https://www.i3cglobal.store/templates/
Explain the 510(k) requirement for the Biocompatibility. What is expected by a reviewer?
If the medical device involves components that come into direct or indirect touch with tissue, the FDA requires that the biocompatibility of tissue-contacting materials be evaluated. Biocompatibility testing is carried out in accordance with ISO 10993-1.
Even though the subject device and the predicate device have the same material and construction, biocompatibility studies must be conducted to demonstrate the device’s biological safety.
The reviewer will require information on the testing process and reports in detail. The protocol must comprise the study title and standard, preparation of the test article, thorough test method-positive and negative controls, test parameters and acceptance criteria, and analysis of the results. The report must include an analysis of the test results, conclusions drawn from the data, a photograph of the gadget, and so on.
Is Sterilization validation mandatory for 510(k)?
Only sterile medical devices require sterilization validation. Non-sterile medical devices may not fall under the sterility provision. For Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile and Reprocessed Single-Use Medical Devices, the FDA issued two guidelines.
https://www.fda.gov/media/74445/download
https://www.fda.gov/media/71482/download
Is Shelf-Life studies part of FDA 510(k) Documentation?
FDA 510(k) documentation includes shelf-life studies. If you want to claim a shelf-life span for your device, you’ll need to keep the necessary studies and reports on hand. Even if accelerated studies are acceptable, FDA usually prefers real-time stability studies. To confirm the safety and effectiveness, the FDA required the performance test to be conducted following the real-time/accelerated research.
If the device is supplied sterile, sterilization and packaging validations should be performed after the shelf-life term.
What you mean by Indication of Use? Intended use?
The purpose of your device is defined by its intended use. It specifies what your item is supposed to perform based on the claims mentioned on the packaging.
The reasons or conditions under which the device would be utilized are defined by the indications of use. Under indications for use, the details of the disease or condition that can be diagnosed, avoided, treated, or alleviated by using the device, as well as the patient group for which the device is designed, are listed.
What type of Animal Testing is required to be a part of FDA 510(k) documentation?
Animal studies were used to evaluate the device’s early evidence of device safety, potential performance in a live system, and the biological reaction that a live system would mount to the device.
What type of Clinical Information is part of FDA 510(k) submission?
The clinical study is conducted to collect data to establish the safety and effectiveness of investigational devices.
What is the purpose of Financial Certification or Disclosure Statement in 510(k) Documentation?
If the section does not apply, but the statement “This section does not apply” or “N/A” under that heading if it is part of the FDA 510(k).
Any applicant who files a marketing application for a human medication, biological product, or device, as well as covered clinical studies, is subject to the requirements in this section. Where the application either contracted with one or more clinical investigators to perform the research or submitted studies completed by others who were not under contract to the applicant, the applicant is responsible for making the necessary certification or disclosure statement.
What is the difference between Executive Summary and 510(k) summary?
The FDA 510(k) requirements include a mandated executive summary and 510(k) summaries. https://www.i3cglobal.store/templates/
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