FDA reviewprocess for 510k

The goal of this article is to give a brief idea about FDA 510k medical device submissions process. If a medical device manufacturer wants to sell their medical device in US market then they need to prepare technical dossier, i.e 510(k) which is required by USFDA.

FDA 510(k) dossier making can be challenging for the manufacturer and they need to take consultation from aFDA 510 (k) clearance consultantto make it simple and easy.

510(k) are the premarket notification which contain technical information, safety information and performance information about medical device. To sell your product legally in US FDA FDA review process for 510k is needed to review your 510(k) and clear your device. Mostly Class2,Class 3 and IVDs need 510(k)process. 21CFR807 subpart E describes the requirement for 510(k) submission as there is no form for 510(k).US Food &Drug Administration (FDA) is strict about the submission process so it can be challenging for the manufacturer or seller to prepare for 510(k).

FDA 510(k) is a premarket approval made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval .The common question arises most of the time that when is the 510(k) required? so 510(k) is required When a device manufacturer wants to introduce their device for marketing purpose and based on USFDA classification of the device. They need 510(k) if any change or modification to a legally marketed device and that change significantly affect the safety and effectiveness of that device, any modification in accordance with QSR(Quality System Regulation) 21CFR820 and recorded in change control record .

• Things need to remember to avoid the rejection of 510k

To avoid rejection don’t constrained yourself with the testing summaries, submit a report with specified guideline, follow the protocol and reports. Another point is 510(k) revolves around predicate device.one need to prove that device is safe and effective, as per legally marketed predicate devices so questions should not get arises on devices safety and efficacy.

FDA review process for 510k medical device submissions:

Process of submission for 510k:

Submitter should start with submitting e-copy of it’s 510(k) to CDRH or DCC (Document Control Center).

• DCC will assign a unique control number i.e 510(k) number.
• Verification check for fee payment and a valid e-copy of 510(k).
• Acknowledgement letter which identifies date of receipt and 510(k) number assign to submission. Point to be noted here is acknowledgment letter is for correspondence with FDA it is not for market clearance letter.
• After the acknowledgment letter, the case is sent to respective OHT(offices of health Technology) as per the device type and specialty.
• 导致评论家进行验收检查with said the acceptance checklist as per FDA guidelines.
• Within 15 days of the receipt of submission ,the submitter will receive e notification of Acceptance Review result which describes,

1. The name and contact information of FDA lead reviewer
2. Status of 510(k) submission.
3. This review result can be one of this:

a) 510(k)accepted for substantive review, b) refused to accept or RTA c) or under substantive review as FDA didn’t complete acceptance review within 15 calendar days. if it is placed for “RTA hold” then submitter has 180 calendar days to address the deficiencies cited in RTA hold.

The below chart gives us idea about FDA 510(k) review timeline ;The Below flow-chart is a simplified summary of event during course of 510(k) submission :

The chart indicates that process takes 90 calendar days timeframe ,The submitter expect 7 days for the acknowledgement letter and 15 calendar days for acceptance review decision: substantive review decision within 60 days and final within 90 days. Although this new chart is just a chart and not a track record of FDA review performance, it does provide a much clearer picture of what 510(k) applicants can expect from the US regulator once their registrations get underway.

Asmedical device regulatory consultantour team tried to spread light on the timeline for FDA review process of 510(k) for medical devices.