My DD is from a white paper (dated 12 April 2016) from EMERGO titled..
"US FDA 510(K) PREPARATION
An overview of the US FDA 510(k) process for medical devices"
The Author is
"Robert Seiple, RAC Senior Consultant, QA/RA USA Office www.EmergoGroup.com"
It removes all the KOOLAID out of the equation...
It's 10 pages long and can be download if you provide your email from the link below...
http://www2.emergogroup.com/e/10582/resources.../650123306
Here is an interesting part...
"The agency also uses the “Additional Information Required” (AI) process to request more information. However, the agency recently adopted a one-response requirement for AIs, in which sponsors receive one opportunity to address the FDA’s concerns or requests for additional information. Should that response be inadequate or incomplete, the submission may be deleted. Note that the 90-day clock stops for both RTA and AI responses (maximum of 180 days for each). In some cases, the FDA is requiring clinical studies where none were requested previously to provide documentation of efficacy."
Best they take their time on the AI response as they only get one chance ... So I do not expect it anytime soon.
And after that, the review clock resets to 90 days... (not including weekends), so 4.5 months.
Here is the other part describing the review process..
"510(k) Review
The FDA timeframe for 510(k) review is 90 days. However, these are 90 “FDA days” - weekends, holidays, etc. are not included. More importantly, the 90-day review clock stops in the event of a Refuse-to-Accept (RTA) letter or an Additional Information Required (AI) letter. If the FDA issues a Refuse-to-Accept letter, the clock has not started because the FDA has not accepted the submission for review. Sponsors have 180 days to resolve RTA issues. There can be more than one RTA.
If an Additional Information Required (AI) letter is received, the FDA clock stops again for up to 180 days. These delays are under the sponsor’s control, as the clock re-starts when the revised submission is provided to the FDA and accepted. FDA now also allows only a single AI, so this response is critical. Note that if responses are not received during the 180-day time frame, the FDA will delete the submission without refunding the user fee. Generally, you should plan for the 510(k) submission to take no less than 4-6 months"
"US FDA 510(K) PREPARATION
An overview of the US FDA 510(k) process for medical devices"
The Author is
"Robert Seiple, RAC Senior Consultant, QA/RA USA Office www.EmergoGroup.com"
It removes all the KOOLAID out of the equation...
It's 10 pages long and can be download if you provide your email from the link below...
http://www2.emergogroup.com/e/10582/resources.../650123306
Here is an interesting part...
"The agency also uses the “Additional Information Required” (AI) process to request more information. However, the agency recently adopted a one-response requirement for AIs, in which sponsors receive one opportunity to address the FDA’s concerns or requests for additional information. Should that response be inadequate or incomplete, the submission may be deleted. Note that the 90-day clock stops for both RTA and AI responses (maximum of 180 days for each). In some cases, the FDA is requiring clinical studies where none were requested previously to provide documentation of efficacy."
Best they take their time on the AI response as they only get one chance ... So I do not expect it anytime soon.
And after that, the review clock resets to 90 days... (not including weekends), so 4.5 months.
Here is the other part describing the review process..
"510(k) Review
The FDA timeframe for 510(k) review is 90 days. However, these are 90 “FDA days” - weekends, holidays, etc. are not included. More importantly, the 90-day review clock stops in the event of a Refuse-to-Accept (RTA) letter or an Additional Information Required (AI) letter. If the FDA issues a Refuse-to-Accept letter, the clock has not started because the FDA has not accepted the submission for review. Sponsors have 180 days to resolve RTA issues. There can be more than one RTA.
If an Additional Information Required (AI) letter is received, the FDA clock stops again for up to 180 days. These delays are under the sponsor’s control, as the clock re-starts when the revised submission is provided to the FDA and accepted. FDA now also allows only a single AI, so this response is critical. Note that if responses are not received during the 180-day time frame, the FDA will delete the submission without refunding the user fee. Generally, you should plan for the 510(k) submission to take no less than 4-6 months"
