FDA 510k Consultants Recommended

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Update time : 2024-07-24

FDA 510(k) submission:

If you are not familiar with the medical device FDA 510(k) submission process, you have come to the right place! Listed here are the various steps and types involved in the submission process.

The careful planning and expertise of our advisors will ensure early approval of your 510(k) submission without an RTA or AI and ensure successful approval of your 510(k) submission.

FDA 510k Consultants Recommended(图1)

All applicants must submit a CD and electronic copy of the U.S. Agent that requires all foreign manufacturers to officially have FDA certification letters. (Note: The services of a U.S. Agent are different from those of an agent registered with a U.S. institution).

FDA 510k Pre-Submission (Q Submission)

A pre-submission or Q-submission allows the manufacturer/applicant to request formal feedback on your medical device 510(k) filing, particularly in areas such as (a) testing procedures, (b) substantial equivalence, (c) missing sections, etc.

A Pre-Submission or Q-Submission allows the manufacturer/applicant to request formal feedback on your medical device 510(k) file, specifically regarding (a) testing procedures (b) substantial equivalence, (c) missing parts, etc.), before you pay for FDA review and submit your 510(k) application.

Benefits before submission:

1. Improved the quality of the final 510k file,

2. Enhance the transparency of the review process,

3. Smooth and clear comments and reviews,

4. The total review time may be shortened,

5. No Charge

Consultants and US Agents for FDA 510k submissions:

FDA reviewers may review your 510(k) submission multiple times until all supporting evidence submitted is compliant. Nothing works more efficiently when you engage an experienced consulting firm to complete and submit your FDA 510(k) in a timely manner.

Our Support:

1. Look up FDA regulations and facility codes.

2. Confirm again whether the classification is correct.

3. Determine who will be the owner and official agent for the 510k submission process.

4. Confirm that the predicate device is close to the device in question.

5. Designate U.S. agents for foreign manufacturers and specification developers.

6. Pay close attention to the format of your submission.

FDA certification 510k submission content:

1. Medical Device User Fee Cover Sheet (FDA-3601)

2. Cover of CDRH Pre-market Review Opinion

3.510k Application Form

4. Instructions for use

5.510k Abstract

6. True and accurate declaration (FDA certification template)

7. Class III Summary and Certification

8. Financial Certification or Disclosure Statement

9. Declaration of Conformity and Summary Report

10. Executive Summary

11. Equipment Description

12. Discussion on Substantial Equivalence

13. Suggested Tags

14. Sterilization and shelf life

15. Biocompatibility

16. Software

17. Electromagnetic compatibility and electrical safety

18. Performance Testing – Benchmarks

19. Performance Testing – Animals

20. Performance Testing – Clinical

Given above are the basic contents of the 510k file that must be followed in the 510k submission process. Device-specific files and changes to the description files with evidence can also be submitted in Special 510k.

FDA certification 510k submission process and clearance:

The first stage	stage	Activity	timeline
	1	Select medical devices and models to obtain USFDA approval	20 days
	2	With the same
	2	Indication and technical identification of predicate devices
	3	If not completely equivalent, follow the PMA route; if substantially equivalent, follow the 510k route
	4	Appointed Shangtong Testing as technical consultant
	4	and US customs clearance agent

second stage	5	Identify equipment codes and regulatory numbers and verify predicate equipment, indications and technologies	60 days
	6	Identify equipment categories and guidance documents
	7	Identification of biological evaluation and testing requirements for devices that meet predicate
	8	Samples sent to the laboratory
	9	Evaluate Equivalent Device Compilation
	10	Draft 510(k) submissions consistently with available FDA guidance documents.
	11	Review risk analysis, equivalent device data, biocompatibility testing/safety testing protocols
	12	Label review, user manual/IFU, shelf life records/life calculations, and preclinical research evidence
	13	Before Submission

The third phase	14	Compiled by incorporating pre-submission reviews	60 days
	15	Compilation of preclinical and biocompatibility/safety testing
	16	Compile and publish final draft
	17	Comment

Stage 4	18 years old	U.S. Agent Appointment	20 days
	19	Review Payment
	20	Submit printed and electronic copies
	21	Receive receipt
	22	Waiting for comments	60 days

Stage 5	23	Modify 510k based on FDA review comments and provide other supporting documentary evidence	30 days
	24	Resubmit	10 days
	25	Waiting for review comments or 510k clearance letter	60 days

Typically, the FDA 510k process (document preparation and submission) and device testing takes about 4-5 months. After submission, FDA certification typically takes 3 to 10 months to complete, including closing the audit inquiry.