Failure to write an acceptable 510(k), including the formatting and presenting of all the documented evidence to support claims of substantial equivalence can result in endless delays. Delays driven by the agency’s failure to accept or round-after-round of clarification questions can take a process that is expected to last just 90-days to several months past the initial 90-day target. The endless delays end up costing device establishment valuable revenue dollars lost, due to these delays.
Speed to market is everything for medical device establishments. Considering all of the costs associated with the design and development of medical devices, it is imperative that device establishments quickly and successfully navigate the often treacherous regulatory waters associated with the FDA’s 510(k) process. Establishing substantial equivalence to a predicate device is premised on the successful scripting of a 510(k), supported by empirical evidence.
This presentation by industry expert, Dr. Christopher Devine is a must-attend for all industry professionals, involved in the 510(k) process will benefit from this training as the 510(k) is a salient requirement for placing Class II device onto the US market through claims of substantial equivalence.
Areas Covered in the Session :
- Understanding the different types of 510(k)s (traditional, special, and abbreviated)
- Understanding the meaning of substantial equivalence
- Deliverables required for a traditional 510(k) – brief review of each section
- 510(k) Formatting
- FDA required forms (3601, 3881, & 3654)
- Pre-review & Screening Checklists
- Preparation of paper and e-copy
- Failure to Accept
- FDA review deficiencies, how to correctly respond to a deficiency
Who Will Benefit:
- Regulatory Affairs Departments
- Research & Development Departments
- Quality Assurance Departments
- Quality Control Departments
- Quality System Management
- Senior management