FDA Final Guidance Q-Submission Program

Today FDA issued a final guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.  Guidance for Industry and Food and Drug Administration Staff Document (May 7, 2019).  The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions.

In our opinion, early feedback and interaction with FDA can be very valuable to ensure timely and successful submissions but with a caveat.  We recommend companies focus on grey areas or aspects open to interpretation, rather than routine aspects of submissions for their particular product and technology type. In addition, we suggest not asking open ended questions, but rather presenting approaches that the company prefers at least at first.  Then evaluate feedback from FDA and if what FDA suggests seems overly burdensome consider further interaction and rationale for alternate approaches.

Download the guidance at this link:  Requests for Feedback and Meetings for Medical Device Submissions-The Q-Submission Program-2019

You may be interested to also read our post of the recent De Novo submission guidance at this link:  FDA Final De Novo Submission Guidance

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

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https://events.eventzilla.net/e/december-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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