510k submission

 

510k Submission Process

The 510k submission is the second most common pathway for marketing a medical device in the United States. It demonstrates that the device is substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. A 510k Submission document preparation including device testing, and clinical data consolidation takes up almost 4 to 5 months. Post submissions to the FDA generally take up to 6 months, for closing the review queries.

 

Our 510k consultants’ careful plan, strategic decisions, and expertise will ensure the early acceptance of the 510k file without RTA or AI and the successful 510k clearance of the submission. All applicants must submit a soft copy on CD and an e-copy. All foreign manufacturers are requested to have a US Agent for FDA correspondence officially.

 

Note: The service of the US Agent is different from the US Agent service for Establishment Registration.

Pre and Q 510k Submission

Pre or Q 510k Submission are the two types of submissions that allow the manufacturer/applicant to request formal feedback on files specific to (a) Test Protocols, (b) Substantial Equivalence, (c) Missing Sections, etc.

 

It allows the manufacturer/applicant to request formal feedback on the files of your medical device, specifically on (a) test protocols (b) substantial equivalence, (c) missing sections, etc. before you make a review payment and submit an application.

Would you like us to send an email with important information about 510(k) service within the next 2 minutes?

EMAIL *

Benefits of Pre 510k Submission

Although Pre-Submission / Q 510k submission is not mandatory, we often recommend customers do so to gain an FDA view of the documents and if you have specific questions to the FDA to clarify. The consultants use this provision to seek valuable feedback on various topics, such as costly bench and animal testing, and clinical trials.

 

• Better clarity on subject device requirements
• Improved quality of final 510k file,
• Enhanced transparency of the review process,
• Smooth and clear review comments,
• Potentially shorter total review times,
• No fee

We offer the best guidance and solutions for 510k submission to worldwide manufacturers and specification developers. Our services are time-bound and economical. We match prices. So partner with us and experience the difference firsthand.

REQUEST PROPOSAL

510k Submission Timeline

The duration of the 510k submission process and timeline can vary significantly depending on factors such as the complexity of the device, the completeness of the submission, and any interactions required with the FDA. Generally, the Food and Drug Administration aims to complete the review process within 90 days of acceptance, but actual timelines may be longer in the majority of the cases of applicants.

PHASE I	Stages	Activity	Responsibility	Timeline
	1	Select the Device and models for US FDA 510k approval	CLIENT	20 Days
	2	Identify Predicate Device with the same indication and technology	CLIENT + I3C
	3	If NOT substantially equivalent, follow the PMA route or, if substantially equivalent, follow the 510k route	CLIENT + I3C
	4	Appoint I3CGLOBAL as Technical Consultants and US Agent	CLIENT
PHASE II	5	Identify Device Code and Regulation Number along with verification of  Predicate Device, indication & technology.	I3C	90 Days
	6	Identify the device Class and guidance document	I3C
	7	Biological evaluation and test requirement identification in line with the predicate device	I 3 C
	8	Samples send to the Laboratory	CLIENT
	9	Evaluation of equivalent device compilation	I3C
	10	Drafting of 510k file in line with available FDA guidance document.	I3C
	11	Review of Risk analysis, Equivalent device data, Biocompatibility Test/Safety  test protocols	CLIENT + I3C
	12	Review of Labels, User Manual/IFU, Shelf-life records/lifetime calculation, and pre-clinical study evidence	CLIENT + I3C
	13	Pre 510k submission	CLIENT + I3C
PHASE III	14	Compilation  of 510k file by incorporating the pre-submission comments	I3C	90 Days
	15	Compilation  of Pre-clinical and Biocompatibility and Safety testing	I3C
	16	Compilation and release of the final draft	I 3 C
	17	Review	I3C
PHASE  IV	18	US Agent Appointment	CLIENT	20 Days
	19	Review payment	CLIENT
	20	eSTAR submission of file to FDA	I3C
	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 + I3C	60 Days
	24	Re-submission	I3C	10 Days
	25	Wait for the review comments or FDA 510k clearance letter	CLIENT	90 Days