<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

Adoption of UDI by Select Countries: Similarities and Differences To review the basics of UDI and building a UDI program, start by reading Part I of this two-part series. Today, the world is attempting to align to a single approach for unique device identification (UDI). This rule requires medical device manufacturers to label their products […]

The recent ICH Q9: Quality Risk Management revision includes new guidance on facilitating a risk-based decision-making approach using science and knowledge. Kevin O’Donnell, PhD, Market Compliance Manager, Irish Health Products Regulatory Authority (HPRA) provided an update on the ICH Q9 revision at the 2021 PDA/FDA Joint Regulatory Conference last fall, ahead of the December 2021 […]

Author’s Note: Effective February 7, FDA will be resuming domestic surveillance inspections following a pause in onsite inspections due to concerns about the Omicron COVID-19 variant. What will domestic FDA inspections look like post-COVID? What is FDA’s onsite inspection strategy as the COVID-19 pandemic lingers? What are the best ways to prepare for a records […]

How is the world aligning when it comes to unique device identification (UDI)? Why is it important to understand where a medical device has been used, where it exists in the supply chain, and where it exists at any given point in time?  [Related: Looking for more information on UDI? Click here to access a […]

FDA Regulator Panel Discussions: Part III FDA regulator panels at industry association meetings in Fall 2021 brought to the forefront issues that agency compliance personnel are seeing during inspections and interactions with industry. This final part of a three-part article series provides a synopsis of comments made at the 2021 ISPE Annual Meeting held in […]

FDA Regulator Panel Discussions: Part II Quality culture and issues with responses to FDA records requests performed in lieu of inspections were prominent topics during the “Inspection-Based Panel Discussion” at the September 2021 PDA/FDA Joint Regulatory Conference.[Related: For more on quality culture, view the recent Redica Systems webinar, “The Past, Present, and Future of Quality […]

FDA Regulator Panel Discussions: Part I The topic of data integrity and its continuing significance took center stage during regulator panel discussions at key association meetings in late 2021. During the “Inspection-Based Panel Discussion” at the 2021 PDA/FDA Joint Regulatory Conference this year, other topics discussed included issues FDA has seen with records requests, the […]

Engaging Stakeholders Part I of this article covered Ron Yustein’s discussion of the CDRH Signal Management Program. Part II goes into detail on agency policies and actions regarding stakeholder engagement. Medical device manufacturers, did you know there are times when the Center for Devices and Radiological Health (CDRH) will inform the public that FDA has […]

Signal Detection and Management At the time a medical device is approved or cleared, it has a benefit-risk profile that healthcare providers, patients, and consumers use to make decisions. Device manufacturers work diligently to ensure their products are safe and beneficial as part of the development and application processes. [Related: Looking for more medical insights? […]

When a 483 is issued to a medical device company after an inspection, how should the company respond? What should the response contain? What does FDA look for in a 483 response? And how does the company response impact whether the agency will issue a Warning Letter? At the virtual 2021 FDA/Xavier MedCon conference, FDA […]