FDA 510(k): Preparation, Submission, and Clearance Medical Devices
This webinar is intended to discuss regulatory requirements for FDA 510(k)s: in particular, 510K) preparation, submission and a successful clearance under the current FDA situation.
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.
To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance.
At the end of this webinar, you will become better aware of the FDA 510(k) concerning recent trends, new strategy, submission and FDA clearance. You will plan and execute your practice differently in a more effective manner using the speaker’s guidance – CAC-SI method.
Areas Covered in the Session:
- Statute(s) and regulations
- Medical device classification including IVDs
- When is required to submit a 510(k)
- Predicate device(s)
- De Novo process – practical tips
- How to demonstrate substantial equivalence
- Contents and format for 510(k)s
- eCopy, RTA policy and recent FDA guidance (finalized)
- Technical and regulatory requirements
- Addressing our performance data and clinical data in a succinct, comprehensive manner.
- 510(k) submission quality for a product.
- Best practices for responding to FDA’s request of additional information.
- Resolving different opinions between the submitter and FDA reviewer(s).
- Common hurdles
- Best practices for 510(k) preparation and submission
- Speaker’s PASS-IT recommendations: Best Practices
Who will benefit:
- Regulatory Affairs Managers, Directors and VPs
- Clinical Affairs Personnel (Coordinators, Monitors, Managers, Directors, and VPs)
- R&D Scientists, Engineers, Managers, Directors, and VPs
- Quality Engineers, Managers, Directors, and VPs
- Compliance Officers and Legal Counsel
- Complaint Handling and Risk Management Managers and Directors
- Clinical investigators and CRO Employees
- Senior and Executive Management
- Anyone Interested in the 510(k) Submission