Consultancy for US Legal Requirements

CONSULTANCY for US Regulations

510(k) Premarket Notification and Product Registration to USA

FDA registrations are required for medical devices to be sold to the US market. The FDA classifies medical devices as class I, class II, and class III. This classification has sub-categories within itself.

Direct registration can be performed for Class I (exempt) products without any conformity assessment.

Products that are not class I exempt are subject to a conformity assessment program called class II products and some class III 510 (k). For this, 510 (k) file is prepared to be submitted to the FDA.

510 (K) processes are performed according to the schedule below. Companies approved for 510 (k) compliance continue with the FDA registration process and after the completion of the FDA registration process, product sales to the USA become possible.

By Day 1:

FDA receives 510(k) application

By Day 7:

FDA sends Acknowledgement Letter
FDA sends Hold Letter if unresolved issues with User Fee and/or eCopy

By Day 15:

FDA conducts Acceptance Review
FDA informs applicant if 510(k) is accepted for Substantive Review
Placed on RTA Hold

By Day 60:

FDA conducts Substantive Review (usually by day 60)
FDA communicates Substantive Interaction with applicant that
İndicates FDA will proceed with Interactive Review or ask for Additional Information.

By Day 90:

FDA sends final MDUFA Decision on 510(k) (usually by day 90)

By Day 100:

If MDUFA Decision is not reached by Day 100 provides Missed MDUFA Decision Communication that identifies outstanding review issues.



ISO 13485:2016
CE Marking
510(k) Fundamentals



Biomechanical Testing
Finite Element Analyze