US FDA 510k

US FDA 510k is a Premarket Submission made to Food and Drug Administration to demonstrate that the device to be marketed in USA is safe and effective and is substantially equivalent to device which is already in market after FDA clearances. During the FDA 510k approval process, the medical device’s safety, risks benefits and other information are looked upon. A successful 510k submission or 510k clearances means FDA gives permission to sell the product after completing the establishment registration and device listing.

Most Class II (and some Class I and Class III) medical devices are subject to FDA 510k submission and clearance process. This whole concept is based upon substantial equivalence and is unique to the US medical device regulations. So, the objective is to show that your device is substantially equivalent to some other devices already on the US market with 510k number (k number) .

We are FDA 510k consultants or can be also called as 510k Submissions experts and Consultants. Our 510k consulting experts provide complete support from equivalent device identification to final stage of FDA approval process.

Special Features of MedDeviceCorp; 510k Submissions Experts And Consultants

  • We will not assist, we prepare FDA 510k submission documents!!!.
  • We provide Inhouse US Agent service.
  • Initial in-depth study of product and regulatory followed by overall 510k submission guidance.
  • Development of a Project Plan and confirmation of the specific deliverables.
  • Guidance on testing.
  • Communicate to FDA regarding 510k review and closing of review comments till 510k clearances/approval.
  • 21 CFR 820 Implementation support.
  • Medical Device Establishment Registration post 510k approval.
  • Medical Device List with US FDA post 510k approval.
  • Payment after completing every important phases.

USFDA 510k Submissions Process

1. Equivalent / Predicate Device identification with device code and regulation number

2. Drafting of 510k

3. Testing of device as per abbreviated / traditional 510k requirement

4. Review Test protocols

5. Review of shelf life and sterilization documents

6. Review of safety protocols and reports

7. FDA Pre submission

8. Make necessary correction in 510k file based on pre-submission comments

9. Do a second pre-submission if required

10. Final review and Consolidate 510k.

11. FDA review fee payment

12. Submit file to FDA

13. Wait for review comments

14. Modify and resubmit the file based on review comments

15. Wait for 510k clearances letter and 510k number.

US FDA 510k Consultation And Submission Fees

510k Consultancy and FDA review fees depends on number of devices.

  • FDA Review fees for the FY 2018-19 is 10953 USD.
  • Guidance, 510k preparation and FDA coordination for the FY 2018-19 starts from 9999 USD
510k Preparation, 510k Review And Clearances Timeline.

When thinking about submitting new FDA 510(k) application the first question is how long and how much cost. We already discussed the costing in the earlier section. Timeline, given by FDA is 90 calendar days to review a 510k, however, the average time from our experience is 14 to 18 months.

Timeline depends on the following important factors.

  • Customer team cooperation with MEDDEVICECORP 510k Consultants,
  • Perfection of documents submitted,
  • Quality of the test protocols,
FDA 510k Submission Contents.

The following are the important section in the 510k submission file. Customers are requested to check back the traditional and abbreviated standards requirements before proceeding.

A. Cover Sheet Forms

  • Medical Device User Fee Cover Sheet (Form FDA 3601)
  • CDRH Premarket Review Submission Cover Sheet

B. Public Information Documents

  • 510(k) Cover Letter
  • Indications for Use Statement
  • 510(k) Summary

C. Certification and Statements from Manufacturer

  • Truthful and Accuracy Statement
  • Class III Summary and Certification
  • Financial Certification or Disclosure Statement
  • Declarations of Conformity and Summary Reports

D. Predicate(s) Device comparison

  • Executive Summary Note
  • Device Description and Identification
  • Substantial Equivalence Discussion

E. Patient and User Safety

  • Proposed Labeling
  • Sterilization and Shelf Life
  • Biocompatibility

F. Software and Electronics

  • Software
  • Electromagnetic Compatibility and Electrical Safety

G. Performance Testing

  • Bench Testing
  • Animal Testing
  • Clinical Testing

Often applicants find the pathway to 510k clearance is confusing, lengthy and full of roadblocks, but technical knowledge and team work during the file preparation makes process simpler and streamline the review process to ensure fast clearance. so the right file preparation and Submission helps to reach the target faster.

Customers are advised to take additional help in preparing your 510k. Meddevicecorp 510k Consultants are there to help you. write to or call us.