Getting your device approved or cleared by FDA is a critical step, of course, but it's only the beginning of your relationship with US federal regulatory agencies.
In this free 60 minute webinar, we will examine the ongoing FDA compliance obligations a device manufacturer has to deal with after PMA approval or 510(k) clearance.
It will cover issues that impact both domestic and international device companies.
Specifically you will learn:
- What you should know about FDA inspections
- An overview of Quality System Inspection Techniques (QSIT)
- QSR and design issues that may surface in the domestic production or importation of devices or components
- Understanding the intersection between FDA and US Customs
- What does you company need to do if things do go wrong with FDA
About the presenters:
Mr. Thomas Knott provides regulatory assistance to companies of all sizes through his role as a Senior Regulatory Advisor with FDAImports.com, LLC,
As part of the FDAImports.com team, Mr. Knott has helped clients with the FDA Pre-Market Notification [510(k)] clearance and de novo processes, including setting up pre-submission meetings with FDA. He has reviewed device and biologics labels. Regarding Good Manufacturing Practices and Quality System issues, he has responded to Inspectional Observations (Form FDA 483) and helped develop Quality Systems for manufacturers. Mr. Knott has also reviewed and critiqued both FDA and private lab reports.
Mr. Knott has over 30 years of experience at FDA serving in a wide range of capacities at the Agency’s Districts, Headquarters, and the Center for Devices and Radiological Health (CDRH) including as a Branch Chief in the Office of Compliance in CDRH.
John Johnson III practices FDA and Customs law at Benjamin L. England & Associates, LLC with a focus on integration of the two agencies’ regulatory compliance requirements, and has extensive experience with representing FDA-regulated clients before FDA, USDA, Customs and other regulatory agencies.
Mr. Johnson aptly deals with FDA Compliance Officers, Headquarters Officials, Customs officials, laboratories, warehouses, and brokers to remove obstacles at every step along the way. This routinely includes developing individualized import and export operating procedures to smooth and expedite the movement of highly-regulated goods, and to minimize the impact of import alerts, detentions, product recalls, and market withdrawals.
To minimize the risk of FDA scrutiny and enforcement actions, Mr. Johnson advises firms on regulatory compliance. This work includes assisting firms with labeling, marketing, and formulation compliance. Additionally, he assists firms with current Good Manufacturing Practices and HACCP obligations, and with developing and implementing Standard Operating Procedures to strengthen internal programs and ensure compliance.
