FDA update September 27, 2011

Guidance for Industry: FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment

The purpose of this document is to assist agency staff and the device industry in understanding how various FDA and industry actions that may be taken on 510(k) s should affect the review clock for purposes of meeting the MDUFMA performance goals.

For 510(k) submissions, the performance goals contain both cycle (i.e., “first action” and “second and later action”) goals and decision goals. A “cycle” (or review cycle) is the period of time (in FDA days2) beginning with the date FDA receives the 510(k)3 and ending with the date FDA issues a letter requesting additional information or announcing a “decision” (e.g., substantially equivalent (SE) or not substantially equivalent (NSE) determination). More than one cycle may occur before FDA issues its decision on the 510(k) submission.

FDA has committed to meeting the following action and decision goals

• An FDA decision (i.e., issuance of a SE or NSE determination letter) will issue within 90 days (cumulative FDA review time)
• First action additional information (AI) letters will issue within 75 days
• Subsequent action additional information letters will issue within 60 days.

FDA may take any of the following actions on a 510(k) after FDA has conducted its review (21 CFR 807.100(a)):

• issue an order declaring a device SE (SE letter)
• issue an order declaring a device NSE (NSE letter)
• request AI
• advise the submitter that the 510(k) submission is not required (i.e., product is not regulated as a device or device is exempt from the premarket notification requirements of the act)
• agency may consider a 510(k) to be withdrawn if additional information is not provided within 30 days following issuance of a request for additional information. In this instance, FDA may issue a notice of withdrawal.
• A notice of withdrawal is sometimes referred to as a “deletion letter.” The term “deletion” is used to differentiate a withdrawal under 21 CFR 807.87(l) from a request to withdraw a pending 510(k) by the submitter.

Request AI by letter (“formal” AI request) FDA generally requests AI by letter when the agency believes the additional information is not minor in nature and/or cannot be provided within a reasonable period of time (i.e., such that the review will not be delayed).

Request AI by means other than letter (“informal” AI request) FDA generally requests AI by means other than a letter when the agency believes the additional information is relatively minor in nature (e.g., a simple change to the device’s proposed labeling) and can be provided quickly.

FDA generally will utilize a maximum of three cycles of FDA review to reach a SE or NSE decision.The first review cycle begins upon receipt of the original 510(k) submission, and subsequent review cycles start when we receive responses to our requests for AI by letter. Thus, if there are multiple review cycles, FDA intends to issue a final decision following its review of industry’s response to a second AI request.

Any questions on this FDA guidance please email us at info@mdiconsultants.com and Ref: FDA Review Clock and Performance Assessment

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089738.pdf