FDA FYE medical device user fees going up

 

510 k application fee

Aug 29,  · FDA user fees for the fiscal year have increased across all registration categories. (k) fee paid by companies that don't qualify for small business discount will more than double. Annual Establishment Registration fee increasing 37% with no discount for small businesses. The new (k) is subject to the (k) review fee at the time of submission. Any application from a State or Federal Government entity. Exempt from any fee Author: QD Syringe Systems®. Federal law authorizes FDA to charge a fee for medical device product review. These fees apply to Premarket Notifications ((k)s), Premarket Approval Applications (PMAs), Product Development.


Medical Device User Fees | FDA


The Divisions in these offices are organized according to medical device specialties. One of the two copies must be an electronic copy an eCopy. When the DCC receives the k submission, it assigns the submission a unique control number. This number is commonly referred to as the " k number," or "K number.

The first two digits designate the calendar year the submission was received; the last four digits represent the submission number for the year, starting with and increasing with each new submission. The DCC then conducts two verification checks to confirm that: The proper user fee payment was received for the submission. Note: the user fee amount to be paid is based on when the k is received by FDA and not the date on which it was sent by the submitter.

A valid eCopy of the k submission was provided. The submitter then has calendar days from the date of the Hold Letter to fully resolve the issues with the user fee or eCopy submission. If the issues are not resolved within days, then the k is considered to be withdrawn and deleted from our review system, and the submitter will need to submit a new, complete k to pursue FDA marketing clearance.

If the proper user fee has been paid AND a valid eCopy has been provided, the DCC will email an Acknowledgment Letter to the contact person identified in the k submission. The Acknowledgement Letter identifies: the date of receipt this is the date that FDA received the k submission, the proper 510 k application fee fee payment, and valid eCopy ; and the k number assigned to the submission.

The k number identified in the Acknowledgement Letter should be referenced in all further correspondence with FDA regarding the k. Failure to reference the k number may result in processing delays. Upon receipt in the Division, the k is assigned to the appropriate Branch, 510 k application fee, and then assigned to a Lead Reviewer. In the Acceptance Review, the Lead Reviewer determines whether the k submission meets the minimum threshold of acceptability and should be accepted for substantive review.

Within 15 days of the receipt of the submission, the submitter will receive an electronic notification of the Acceptance Review result, which will: identify the name and contact information of the FDA Lead Reviewer assigned to the k ; and indicate the status of the k. The Acceptance Review result will be one of the following: the k was accepted for substantive review; or the k was not accepted for review i. A k not accepted for 510 k application fee is placed on RTA 510 k application fee. The submitter has calendar days to fully address the deficiencies cited in the RTA Hold.

If this is not done, the k is considered withdrawn and deleted from our review system. If the k is deleted, 510 k application fee, the k submitter will need to submit a new, complete k to pursue FDA marketing clearance for that device.

Once accepted, a k proceeds to the Substantive Review. Substantive Review including Substantive Interaction and Interactive Review During Substantive Review, the Lead Reviewer conducts a comprehensive review of the k submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the k submission. The Substantive Interaction communication is typically: an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or an Additional Information AI request which places the submission on hold.

The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as: Email Telephone Call During Interactive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the DCC, 510 k application fee. No extensions beyond days are granted.

If FDA does not receive a complete response to all deficiencies in the AI Request within days 510 k application fee the date of the AI Request, the submission will be considered withdrawn and deleted from our review system.

If 510 k application fee k is deleted, the k submitter will need to submit a new k to pursue FDA marketing clearance for that device. The submitter must submit the response, with a valid eCopy, to the DCC, 510 k application fee. FDA Days are calculated as the number of calendar days between the date the k was received and the date of a MDUFA decision, excluding the days the submission was on hold for an AI request.

When a decision is made, FDA will issue the decision letter to the submitter by email to the email address provided in the k cover letter. A k that receives an SE decision is considered "cleared.

The following flow chart provides a simplified summary of event and interaction milestones during the course of a k submission. This timeline has been simplified.

 

QD Syringe Systems™: Premarket Notification ~ k Review Fees

 

510 k application fee

 

For (k) clearances, the fee rises from $5, to $5, For premarket applications (PMAs), the fee goes from $, to $, Small Business Break. The US Food and Drug Administration charges a fee to review your k application. FDA (k) Application Review Fee (prices in US dollars) – $4, ($2, for small businesses) FDA classifies as “small businesses” companies with less than US $,, in annual sales. Aug 29,  · FDA user fees for the fiscal year have increased across all registration categories. (k) fee paid by companies that don't qualify for small business discount will more than double. Annual Establishment Registration fee increasing 37% with no discount for small businesses.