Devices

Updated Draft Q-Submission Guidance

FDA has published an updated draft guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, giving an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. The document says the interactions can include written feedback and/or a meeting related to potential or submitted medical device applications.

In an online post, the agency says the updated draft provides:

information to assist applicants in identifying when an informal communication would generally be appropriate instead of a pre-submission or other Q-Submission type;

additional information on the scope of Q-Submission types, as well as clarifications to existing policies and procedures;
content from Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry, with no changes to existing policies and procedures for PMA Day-100 meetings; and
revised examples of common review topics and questions.

Comments on the updated draft will be accepted until 5/14.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome