Overview:
The
FDA 510(k) submission process remains one of the most crucial regulatory
pathways for medical device manufacturers, yet it can be fraught with
challenges. Companies often struggle with the volume of information and the
stringent requirements set by the FDA, which can make the process seem
overwhelming. One common mistake is failing to thoroughly understand the
specific documentation required for submission, leading to delays or outright
rejections.
Many
organizations face difficulties with the concept of substantial equivalence
when selecting predicate devices. A lack of clarity around what constitutes an
acceptable predicate can result in the submission being flagged for further
review or returned for corrections. In some recent cases, companies
underestimated the level of detail required in demonstrating substantial
equivalence, leading to extended review periods and additional costs.
Another
frequent error involves underestimating the FDA’s focus on software components
of medical devices. Missteps in addressing software validation and
documentation have led to multiple submission failures. A well-known
manufacturer faced significant delays after failing to provide adequate
evidence of software testing, pushing back their product launch by several
months. Understanding how to properly address software in the submission can
help prevent such setbacks.
Moreover,
companies often overlook key updates in FDA policies, such as the Refuse to
Accept (RTA) policy, which outlines minimum acceptance criteria for
submissions. A recent case showed how a minor oversight in these initial
criteria led to the rejection of a submission that otherwise could have
progressed smoothly through the review process.
This
webinar will guide participants through the intricacies of the FDA 510(k)
submission process, addressing these common challenges and offering strategies
to help avoid costly mistakes. With a detailed understanding of the submission
requirements, you’ll be better prepared to meet FDA expectations, reduce the
likelihood of rejections, and streamline your product’s path to market.
Areas
Covered in the session:
- 510(k)
unique terminology
- Refuse
To Accept policy
- what
is a predicate device
- Selecting
a predicate device (substantial equivalence)
- Where
to find substantially equivalent predicate devices
- How
to handle software
Learning
Objectives:
This
webinar will explain:
- What
a 510(k) is and the procedure to prepare the submission.
- The
several types of 510(k) will be explained.
- Each
part of the submission will be explained.
- The
very confusing concepts of predicate device and substantial equivalence will be
discussed.
- How
to find an acceptable predicate device will be taught.
- FDA
places special emphasis on device software. we will also cover the requirements
for software.
Why
Should You Attend?
Navigating
the FDA 510(k) submission process can be daunting, with numerous complex
regulations, unfamiliar terminologies, and evolving compliance requirements.
For many medical device manufacturers, submission rejections or delays often
result from avoidable errors in documentation, predicate device selection, or
software validation.
Attending
this webinar will provide you with critical insights into the FDA’s
expectations and how to meet them efficiently. Whether you're new to the
submission process or looking to refine your existing approach, this session
will help you identify common pitfalls and equip you with practical tools to
ensure your submission meets all regulatory requirements.
By
learning from real-world examples and expert guidance, you’ll be better
prepared to streamline your 510(k) process, minimize costly delays, and
increase the chances of getting your device approved for market. Stay ahead of
the curve, avoid unnecessary rejections, and confidently manage your
submissions by joining this webinar.
Who
Should Attend?
This
webinar is designed for professionals in the medical device industry involved
in product development, regulatory affairs, and quality assurance. It is
especially beneficial for those responsible for preparing and submitting FDA
510(k) applications, ensuring compliance, and managing the lifecycle of medical
devices.
- Regulatory
Affairs Managers
- Regulatory
Affairs Specialists
- Quality
Assurance Managers
- Quality
Control Officers
- Compliance
Managers
- Medical
Device Product Managers
- Research
and Development (R&D) Managers
- Validation
Engineers
- Design
Engineers
- Clinical
Affairs Managers
- Clinical
Research Coordinators
- Documentation
Specialists
- Project
Managers in Medical Device Manufacturing
- FDA Compliance Consultants
- Chief Regulatory Officers (CROs)
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 11 years.
Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.