US FDA 510(k) Number

US FDA 510(k) 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 510(k) is not a premarket approval, neither establishment registration nor device listing.  In three situations, an FDA 510(k) 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 major changes to a previously approved device.

A 510(k) would be needed in these cases, and you would need 510(k) clearance before you could register and list and start marketing.

FDA 510(k) 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 510(k) Submission must for

  • Domestic manufacturers introducing a device to the U.S. market.
  • Repacker or Re-labeler who make labelling changes or whose operations significantly affect the device.
  • Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers /exporters introducing a medical device to the U.S. market.

The 510(k) 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 and that change could significantly affect its safety or effectiveness.
  • A new FDA 510k submission is required for changes or modifications to an existing device, where the modifications 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 completely different.

fda 510k

All these complexities necessities the importance of appointing an FDA 510k consultant or agent for submission.

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 in 16 medical specialities. 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

      • With Exemptions
      • Without Exemptions

Class II General Controls and Special Controls

      • With Exemptions
      • Without Exemptions

Class III General Controls and Premarket Approval

Class 1 or 11 devices If not exempt, you need to select the 510(k) 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

  1. To find the class of your device
  2. To find any exemptions may exist (510k)
  3. To find the Regulation Number
  4. To find out GMP is applicable or not
  5. To find out device description
  6. 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 510(k) Consultant is highly recommended. We, as consultants typically assist with 510(k) preparation, review, US Agent, answering FDA review comments. We have good QA and RA consultants with technical and scientific knowledge above 6 years.

The process of FDA 510(k) submission is detailed below.

    • Initial GAP assessment of the medical device in the scope of 510(k)
    • Product analysis
    • Predicate finding
    • Product classification
    • Identify FDA guidance for the specific product
    • The requirement of performance data study
    • Prepare a technical comparison of your medical device to the predicate device(s).
    • Product description writing
    • Label review and modification
    • FDA 510(k) document preparation (we develop, edit, review 510(k) compiled the file. We will not allow the client to work on documentation)
    • Prepare all 21 sections of the FDA 510(k) application.
    • Coordinate for making payment of FDA 510(k) submission fees.
    • Submit the hard copy and eCopy to the CDRH division within the FDA
    • 510(k) follow-up with FDA officials and will be correspondent for further communications with the FDA.
    • Responses to requests for additional information in the shortest time frame.
    • For foreign exporters, we act as US Agents for your firm.
    • US Agent/Consultants Immediately communicates 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 510(k) 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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  • Our FDA 510(k) technical consultants’ previous experiences help improve the quality of 510(k) documents and reduce the review and communication time.
  • 26+ full-time regulatory consultants. Separate consultants involved in the development of individual modules/annex.
  • One-stop solution for a. Consulting, b. Testing, c. US Agent.
  • Payments based on deliverables (Stage wise payment). Payment option in INR, USD, and EUR.
  • Offices in Germany, India & the USA. The average 510(k) preparation timeline is 90 days.
  • Experience counts more than anything!
  • Appoint 510(k) Consultants: The consultant or consulting team should have extensive knowledge and experience with 510(k) submissions for medical devices. The consultants should be in charge of your submissions and communications until you receive your K number.
  • Determine your product (a) is a medical device or (b) a radiation-emitting product: Once it is identified, proceed with compiling the FDA regulatory requirements required for marketing the product in the US.
  • Classify the medical Device: This will help us make sure the 510(k) route can be used to market along with device code submission procedure and other applicable compliance issues.
  • Implement 21 CFR 820 if Applicable: If the product is not exempted from GMP, you need to implement GMP in the manufacturing location. This is not a requirement for 510(k) submission, but all firms registered should be prepared to face Inspection; if failed FDA will issue a warning letter to the manufacturer, and you will be forced to withdraw products from the market.
  • Test the product/Equipment: For preparing FDA notification, test reports and datasheets are essential. The applicable standards have to be identified, and testing to be done from accredited laboratories.
  • Review the Test report: Review of test reports to be carried out based on the standards and acceptance criteria. Any errors in the report cannot be used in the 510(k) notification.
  • Appoint US Agent: Appoint a US Agent for assisting the FDA in communications with the foreign establishment, answering questions concerning the foreign establishment’s devices to be imported into the United States.
  • Prepare 510k Notification and Submit: Prepare 510(k) notification with the help of a consultant, and submit to FDA directly or through UL / Interk / BSI with the help of Consultant / US Agent.
  • Register the establishment: Manufacturer has to register the establishment involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA under section 510(g) of the act.  An owner or operator of an establishment located in any of the states in the US as defined in section 201(a)(1) of the act shall register its name, places of business and list the devices if interstate trading is done.
  • List the device with FDA: Once the establishment registration is done, the products intended to sell in the US have to list under registered establishments. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also submit the FDA premarket submission number.
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

2

Identify Predicate Device with same
indication and technology

CLIENT + I 3 C

3

If NOT substantially equivalent, follow PMA route or  substantially equivalent follow 510k route

CLIENT + I 3 C

4

Appoint MedDeviceCorp as Technical Consultants
and US Agent for clearance

CLIENT

PHASE II

5

Identify device Code and Regulation Number along with verification of  Predicate Device, indication & technology.

I 3 C

90 Days

6

Identify the device Class and guidance document

I 3 C

7

Biological evaluation and test requirement Identification in line with the predicate device

I 3 C

8

Samples send to Laboratory

CLIENT

9

Evaluation of equivalent device compilation

I 3 C

10

Drafting of 510k file in line with available FDA guidance document.

I 3 C

11

Review of Risk analysis, Equivalent device data, Biocompatibility Test / Safety  test protocols

CLIENT + I 3 C

12

Review of Labels, User Manual / IFU, Shelflife records/lifetime calculation, and preclinical study evidence

CLIENT + I 3 C

13

Pre-submission

CLIENT + I 3 C

PHASE III

14

Compilation  by incorporating the pre-submission comments

I 3 C

90 Days

15

Compilation  of Preclinical and Biocompatibility / Safety testing

I 3 C

16

Compilation and release of the Final Draft

I 3 C

17

Review

I 3 C

PHASE  IV

18

US Agent Appointment

CLIENT

20 Days

19

Review payment

CLIENT

20

Submission in Hard copy and E Copy

I 3 C

21

Receipt of acknowledgement

CLIENT

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 + I 3 C

60 Days

24

Resubmission

I 3 C

10 Days

25

Wait for the review comments or 510(k)clearance letter

CLIENT

90 Days

US FDA 510(k) Documentation & Submission Fees

(Consulting, 510k Preparation, Pre-submission, Final Submission & US Agent)

US FDA Medical Device Establishment Registration FY 2022 Fees: $56726 

FDA 510k Review Fee FY-2022 (Standard) : $12745

FDA 510k Review Fee FY-2022 (Small Business): $3186

Clients may make the above payments directly to US FDA

OPTION 1: FDA 510(k) Complete Package Fees

Payable to MedDeviceCorp [Oct 2021 – Sep 2022]

Type of Device

Guidance Fee

510(k) (File) preparation

Submission Fee

Non-invasive

7500 – 8500 USD

5000 – 6000 USD

500 USD

Invasive

9500 – 10500 USD

6000 – 7000 USD

500 USD

Implant

11000 – 12500 USD

6500 – 7500 USD

500 USD

OPTION 2: FDA 510(k) Partial Service Fees

Payable to MedDeviceCorp [Oct 2021 – Sep 2022]

Activity

Cost

Remarks

USFDA 510(k) detailed Review

5500 – 7500 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 *

5000-6500 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

2500 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

5500 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 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.

Request For Quote – Click Here

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?

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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