1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Compliance
  4. >>Guidance

FDA Guidance Directs Researchers On Use Of Patient Advocates

 
• By Elizabeth Orr

A new guidance document from the US agency offers advice on how sponsors can use patient advocates to improve and streamline device clinical trials.

Healthcare-provider
• Source: Shutterstock

In recent years, the medical device industry has become increasingly aware of the important role patients should play in developing new technologies. However, shaping that engagement during the clinical trial process has remained a challenge. A new draft guidance document from the US Food and Drug Administration attempts to fill that gap by discussing ways sponsors can use patient experience and perspectives to better the design and conduct of device clinical trials.

Discussions at the October 2017 meeting of the Patient Engagement Advisory Committee (PEAC) shaped the document, acting FDA commissioner Ned...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Guidance

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Global Medtech Guidance Tracker: July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 
• By Brian Bossetta

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.

FDA’s Small Business Eligibility Process Gets Update Before New Fiscal Year

 
• By Elizabeth Orr

The US FDA has updated its guidance document on small business eligibility determinations for medical device firms. Industry observers urge companies to ask for the status early to avoid any potential hold-ups.

More from Compliance

J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
• By Shubham Singh

The reason for the correction is that if the device momentarily activates but does not cut or staple tissue, providers can be inadvertently locked out during surgical procedures. When a lockout occurs, additional steps are required to open the device and remove it from tissue.

US FDA Webinar Highlights 506J Expectations Amid Ongoing Supply Chain Vulnerabilities

 
• By Elizabeth Orr

A recent CDRH Learn module urges medical device manufacturers to report potential shortages early, even outside emergencies, to help prevent disruptions. Recent natural disasters underscore the need for resilient supply chains, and reported shortages may be added to an FDA list.

Inspection Readiness 101: Be Prepared To Avoid Common Pitfalls When The FDA Comes Knocking

 
• By Brian Bossetta

A panel of regulatory pros offered stakeholders tips for avoiding FDA citations after facility inspections. The July 29 webinar, hosted by ProPharma and Hyman Phelps and McNamara, follows the agency’s May announcement that it plans to up random foreign inspections.