Trimming Back the Burden of FDA’s Software Regulation

Changes in the FDA’s regulation of software makes life a lot easier for medical device manufacturers. FDA faced an overwhelming challenge when it started to develop a regulatory program beyond the basic Quality System regulation and the Software Guidance issued in 2002. Congress and FDA have made huge changes in FDA’s legal jurisdiction, and FDA has made dramatic revision of its regulatory program.

FDA no longer regulates low risk software, premarket guidance documents must be revised or withdrawn, firms can give themselves 510(k) market clearance rather than FDA, firms can substitute requirement of Reports of Corrections and Removals by participating in a voluntary self-help initiative. Perhaps the most beneficial change for everyone is FDA’s participation with the National Institute of Standards and Technology (NIST) to recognize NIST’s reports, which can be used as guidance.

Why You Should Attend:

The changes in FDA’s jurisdiction and regulatory programs for the regulation of software forges the way for major changes in corporate policy for the development and marketing of software products. The financial gains due to the de-regulation and Digital Health Initiative will make firms more competitive and yield greater net profits due to cost savings associated with FDA regulation. Existing regulatory and quality assurance job descriptions need to be revised to incorporate the changes in FDA’s regulatory program.

Learning Objectives:

• Understand statutory exclusions from FDA jurisdiction of software
• Identify which FDA guidance documents must be revised or rescinded
• Update business strategy for marketing mobile applications without FDA’s OK
• Understand the software 510(k) self-approval program and qualifications for participation
• Corporate policy changes for reporting certain software recalls

Areas Covered in the Session :

• 21st Century Cures Act revocation of FDA low risk software jurisdiction
• Guidance documents to be revised or withdrawn
• Revision to mobile apps regulation
• Digital Health Precertification of software by firms
• Postmarket changes in Reports of Corrections and Removals

Who Should Attend:

• Regulatory Affairs Departments
• Software developers and programmers
• Marketing Directors
• Product Development Departments
• In-house legal counsel
• Management Teams
• Consultants

Course Director: CASPER E. ULDRIKS ‎

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.