Understanding the FDA’s revised medical device product guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
OVERVIEW
In early 2018, the US
FDA updated its Premarket Approval (PMA) acceptance process and Refuse to
Accept policy for 510(k) submissions.
The primary issues
that these documents seek to rectify is the number of incomplete and/or
inadequate PMAs that are submitted each year and it is the intent of the FDA
going forward that they will no longer accept submissions that do not meet
their standard of acceptability.
This webinar will
overview the important critical content of these two revised documents to
include the most important checklists that are contained in the Refuse to
Accept Policy guidance that provides acceptability criteria for each 510(k) –
Traditional, Abbreviated, and Special.
The checklists clarify
the content needed in traditional, special, and abbreviated 510(k) submissions
to allow FDA to conduct a substantive review, thereby enhancing the quality of
received 510(k) submissions and improving overall review time.
The Acceptance and
Filing Reviews for Premarket Approval Applications (PMAs) contains other
critically important checklists that cover the acceptance review criteria for
PMAs.
This document also
addresses medical device products which include drug components. The guidance
outlines new requirements direct registrants to include drug patent information
as well as any exclusive marketing rights that may cover a combination product’s
drug component. The FDA requires this information as a factor in determining
whether applications are complete and can proceed to more in-depth reviews.
WHY
SHOULD YOU ATTEND
It is critical, for
those involved in the preparation of 510 (k)s and PMAs that the submissions be
flawlessly prepared to prevent a refuse to accept situation.
Understanding these guidance documents and applying the standards discussed
will significantly mitigate the possibility of a refuse to accept letter from
being received.
AREAS
COVERED
- FDA refuse
to accept policy for 510 (k)
- Guidance
overview
- Acceptance
review timing
- Five
preliminary questions
- Checklist
review
- Acceptance
and Filing Reviews for Premarket Approval Applications (PMA)s
- Guidance
overview
- Grounds
for refusing to accept an application
- Combination
product administrative items
- Checklist
LEARNING
OBJECTIVES
- List and
describe the contents of the Refuse to accept 510 (k) and Acceptance and
Filing Reviews for Premarket Approval Applications Guidance Documents
- Identify
the critical components of each Guidance Document
- List and
describe the five preliminary questions that are identified in the Refuse
to Accept for 510 (k) document
- List and
describe the contents application of the checklists contained in each
guidance document
WHO
WILL BENEFIT
This webinar has been
designed for professionals in the medical device field and who require an
update as to the provisions of the new guidance documents that have been
issued. These professionals includeRegulatory affairs, Quality assurance,
Clinical research, and Data management and monitoring.
For more detail please click on this below
link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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