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Final Q-Sub Guidance Describes FDA Meeting Policy

 
• By Elizabeth Orr

A new final guidance document from the US FDA explains how the agency wants device developers to use its Q-Submission Program to get agency feedback outside the formal product submission process.

Group of business people having a late night video conference meeting. Sitting around a conference table talking and networking. - Image

Device developers looking for additional information on how to best communicate with the US Food and Drug Administration before making a product submission have a new final guidance document to rely on.

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More from Regulation

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Secretary Kennedy’s FDA Visit Included CDRH Stop, Speech Warning Of ‘Agency Capture’

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

More from Policy & Regulation

Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
• By Ashley Yeo

Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025