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FDA releases final version of Q-Sub guidance
7 May 2019
The US Food and Drug Administration (FDA) has published the final version of its guidance document titled 'Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program', superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of interaction with the Agency:
A. Pre-Submissions (Pre-Subs)
B. Submission Issue Requests (SIRs)
C. Study Risk Determinations
D. Informational Meetings
E. Other Q-Submission Types
The guidance also explains which interactions are not within the Q-Submission Program, and provides information on the Q-Sub process and the recommended content of Q-Sub submissions, dependant on the type of Q-Sub..
“Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks. Through our Patient Preference Initiative, we’ve committed to seeking patient input on these types of topics to help inform our regulatory decision making,” said Center for Devices and Radiological Health (CDRH) Director Jeff Shuren.
Specifically, FDA says the list is focused on the patient preference-sensitive areas it believes will have the biggest impact on regulatory decision making, premarket medical device clinical studies and postmarket evaluation.
Alongside the publication of the list, FDA has opened a public consultation to solicit input from patients, industry and health care professionals on improving the list by refining the topics, adding new ones or informing the agency of ongoing or published studies that are relevant to patient preference-sensitive areas.
The list is broken up into four categories: patient values in diagnosis and treatment; relevant clinical endpoints for specific patient populations; patient benefit-risk trade-offs for treatment options or diagnostic approaches; and impact of uncertainty in the benefit-risk tradeoffs. FDA has also broken down the list by individual medical specialty.
“The priorities listed on the webpage may be broadly applicable to many diagnostic/therapeutic areas, while others are specific to a disease/condition or technology,” FDA writes, noting that the list is not exhaustive and may change as patient preference methodologies evolve over time.