The 510k submission must be made:

  • 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.
  • 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.

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.

510(k) clearance

FDA 510k Submission 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.

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.

fda 510k

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

The process flow chart below explains how 510k consultants assist with the identification of 510k submission requirements, and types of 510k submission. Once the right device categorization and predictive device have been determined, the rest of the process is outlined below.

FDA 510(K) Preparation Timeline

The flow chart below shows how 510k consultants help with the 510k submission process. Once the FDA 510k has been completed and submitted to the FDA,  the remaining steps are as follows.

FDA 510(k) submission timeline

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

      • 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 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

  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 Submission 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.

  • Initial GAP assessment of the medical device in the scope of 510k
  • 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 510k document preparation (we develop, edit, review 510k compiled the file. We will not allow the client to work on documentation)
  • Prepare all 21 sections of the FDA 510k application.
  • Coordinate for making payment of FDA 510k submission fees.
  • Submit the hard copy and eCopy to the CDRH division within the FDA
  • 510k 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 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 510k Submission Consultants

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 510k technical consultants’ previous experiences help improve the quality of 510k 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 510k preparation timeline is 90 days.
  • Experience counts more than anything!

  • Appoint 510k Consultants: The consultant or consulting team should have extensive knowledge and experience with 510k 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 510k 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 FDA approved third party agencies such as UL, Intertek, and BSI with the help of a Consultant and 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.
A presentation about 510k process

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 + MDC

3

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

CLIENT + MDC

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.

MDC

90 Days

6

 Identify the device Class and guidance document

MDC

7

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

MDC

8

 Samples send to Laboratory

CLIENT

9

 Evaluation of equivalent device compilation

MDC

10

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

MDC

11

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

CLIENT + MDC

12

 Review of Labels, User Manual / IFU, Shelf-life records/lifetime calculation, and preclinical study evidence

CLIENT +MDC

13

 Pre-submission

CLIENT + MDC

PHASE III

14

 Compilation by incorporating the pre-submission comments

MDC

90 Days

15

 Compilation of Preclinical and Biocompatibility / Safety testing

MDC

16

 Compilation and release of the Final Draft

MDC

17

 Review

MDC

PHASE  IV

18

 US Agent Appointment

CLIENT

20 Days

19

 Review payment

CLIENT

20

 Submission in Hard copy and E Copy

MDC

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 + MDC

 60 Days

24

 Resubmission

MDC

 10 Days

25

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

CLIENT

 90 Days

FDA 510k Submission & Documentation 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.

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