This course discusses the FDA’s regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections. The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions.
Issues to be covered include:
- Structure of the FDA and current FDA regulatory compliance practices - how to work with FDA investigators
- The regulatory approval process – "what the FDA is looking for" in 510ks, PMAs and other pre-approval applications
- The scope of FDA’s compliance programs, policies and potential enforcement actions
- Discussion of post-marketing notification and reporting programs
- Strategies for development of an in-house compliance program for GMPs which ensure successful inspectional outcomes
- Recent FDA enforcement statistics
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. The training may be of interest to industry veterans who need refresher training on these topics.
Typical attendees include those in:
- Regulatory Affairs
- Product Design, Research and Development
- Quality Assurance & Control
- Medical/Marketing Personnel
- Management of Medical Device Operations
Frequently Asked Questions
What is the scope and breadth of Regulatory Submission information/training that will be covered in this course? It appears that the only topic that is truly submission-oriented in nature is the topic on Product Approval Process. Will additional understanding of submission guidances be discussed, or, is the true focus of the training on compliance with what you have already submitted?
The Product Approval Process section is a higher level overview of the types of approvals and to which devices they may be applicable. Specific instructions for each type of submission are NOT covered in the class.
What are some resources that can be utilized to remain current on FDA and industry activities and discussions?
LinkedIn provides connections to various medical device groups. Keywords “device” or diagnostic” can be used to begin the search. The FDA Inspections Group provides current content based on FDA inspections. CfPIE also has a LinkedIn Group which is a forum for professionals to share industry-active topics. The FDA Law Blog (http://www.fdalawblog.net/) covers patent issues, drugs, and other issues outside of only medical devices.