510k Submission

If you’re new to the medical device 510k submission process, you’re in the right place! The various steps involved in the process and types of submissions are set out here.

Careful planning, strategic decisions, and expertise of our consultants will ensure the early acceptance of the 510k file without RTA or AI and the successful clearance of the 510k submission.

All applicants must submit a soft copy in CD and e-copy. All foreign manufacturers are requested to officially have US Agent for FDA correspondence. ( Note: The service of US Agent is different from US Agent service for Establishment Registration).

FDA 510k Pre-Submission (Q-Submission)

Pre-Submission or Q-Submission allows the manufacturer/applicant to request formal feedback on 510k files specific to (a) Test Protocols, (b) Substantial Equivalence, (c) Missing Section, etc.

Pre-Submission or Q-Submission allows the manufacturer/applicant to request formal feedback on the 510k files of your medical device, specifically on (a) test protocols (b) substantial equivalence, (c) missing section, etc. before you make an FDA review payment and submit a 510k application.

Benefits of 510k Pre Submission

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

Know what to be included in the 510k file!!

Given below are the basic contents of the 510k file which has to be followed in the 510k submission process. The device-specific documents and changes describing documents with the evidence can also be submitted in the Special 510k.

FDA reviewers may scrutinize your 510k submission multiple times until all the supporting evidence submitted comply. Nothing works more effectively when weighed against an experienced consulting company for the timely completion and submission of the FDA 510k

Understand the stages

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 + I 3 C
	3	If NOT substantially equivalent, follow PMA route or if substantially equivalent, follow 510k route	CLIENT + I 3 C
	4	Appoint I3CGLOBAL 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	I 3 C	90 Days
	6	Identify the device Class and guidance document	I 3 C
	7	Biological evaluation and test requirement identification in-line with the predicate device	I 3 C
	8	Samples send to Laboratory	CLIENT
	9	Evaluation of equivalent device compilation	I 3 C
	10	Drafting of 510k file in- line with available FDA guidance document.	I 3 C
	11	Review of Risk analysis, Equivalent device data, Biocompatibility Test/Safety test protocols	CLIENT + I 3 C
	12	Review of Labels, User Manual/IFU, Shelf-life records/lifetime calculation, and pre-clinical study evidence	CLIENT + I 3 C
	13	Pre-submission	CLIENT + I 3 C

PHASE III	14	Compilation by incorporating the pre-submission comments	I 3 C	90 Days
	15	Compilation of Pre-clinical and Biocompatibility/Safety testing	I 3 C
	16	Compilation and release the Final Draft	I 3 C
	17	Review	I 3 C

PHASE IV	18	US Agent Appointment	CLIENT	20 Days
	19	Review payment	CLIENT
	20	Submission in Hard copy and E-Copy	I 3 C
	21	Receipt of acknowledgment	CLIENT
	22	Wait for the review comments	CLIENT	90 Days

PHASE V	23	Modify the 510k and provide additional supporting documentary evidence as per FDA review comments	CLIENT + I 3 C	60 Days
	24	Re-submission	I 3 C	10 Days
	25	Wait for the review comments or 510k clearance letter	CLIENT	90 Days

Generally, the FDA 510k process (file preparation and submission) and device testing take up almost 4-5 months. Post submission, the FDA generally takes up to 3-10 months including the closing of the review queries.

510k Submission and Duration

fda 510k consultants