EMERGO SUMMARY OF KEY POINTS:

• US FDA has updated guidance on how to utilize its Q-Submission Program for medical device manufacturers before they submit premarket applications.
• Following MDUFA IV, FDA has revised scheduling and timeframe processes for the Q-Sub program.

New guidance from the US Food and Drug Administration lays out various options whereby medical device manufacturers may request feedback or consultation from the agency prior to submitting premarket applications.

The draft guidance covers four options available to applicants under the FDA Q-Submission Program, including Pre-Submissions or Pre-Subs, Submission Issue Requests (SIRs), Study Risk Determinations (SRDs) and Information Meetings. Q-Submission meetings can cover Premarket Approval (PMA) and 510(K) premarket notification applications, Humanitarian Device Exemption (HDE) and De Novo requests, as well as Investigational Device Exemption (IDE) questions for clinical investigations.

Pre-Sub changes per MDUFA IV requirements

FDA updated its Q-Submission program in accordance with the Medical Device User Fee Amendments of 2017 (MDUFA IV), which set new requirements regarding Pre-Sub meeting scheduling and feedback times.

Pre-Submission (Pre-Sub)

The Pre-Sub option entails a written request from a market registrant for written feedback from FDA, with or without a face-to-face meeting to discuss the request. The Pre-Sub route allows manufacturers to receive FDA feedback before formal submission of a premarket application.

“A Pre-Sub is appropriate when FDA’s feedback in specific questions is necessary to guide product development and/or submission preparation,” states the FDA guidance.

Submission Issue Requests (SIR)

Manufacturers may use SIRs to request FDA feedback on how to address hold letters, which FDA issues when the agency requires additional information for premarket applications or identifies deficiencies in such applications.

The guidance defines SIRs as “intended to facilitate interaction between FDA and the submitter to quickly resolve or clarify issues identified in these letters so that projects can move forward.”

However, applicants should not issue SIRs in cases where final decisions have been issued.

Study Risk Determinations (SRD)

SRDs are appropriate in cases where clinical study sponsors require FDA determinations on whether planned clinical studies pose significant or non-significant risk, or if studies are exempt from IDE regulations.

Sponsors must make initial risk determinations for studies that do not qualify for IDE exemption.

Informational Meetings

Finally, manufacturers may request informational meetings wherein they may share data with FDA without necessarily receiving feedback from the regulator. Informational meetings may be useful for presenting overviews of device development efforts or helping familiarize FDA staff with new devices or technologies before premarket application efforts begin.

What to include in a Q-Submission to FDA

For any type of Q-Sub preparation, the guidance recommends the following be included in such a submission to FDA:

• Submitter’s contact information
• Type of Q-Sub request
• Proposed meeting agenda, format and preferred dates and times (for Q-Subs with meeting requests)
• Purpose of the Q-Sub, as well as goals for the outcome of an FDA interaction
• Device description and proposed indications for use or intended use
• Regulatory history of the device in question

The guidance includes additional recommendations specific to each type of Q-Sub, as well as submission checklists and sample questions for manufacturers.

Additional US FDA regulatory resources from Emergo:

• US FDA Pre-Sub (Q-Sub) consulting for medical device companies
• FDA consulting support for medical devices and IVDs
• FDA 510(k) consulting for medical device and IVD manufacturers