[Tutor] 510k Submission for Device and Software Changes New Guidance
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[1]A Regulatory Perspective: FDA's [2]OCP_Logo
New Guidance's Deciding When to Call 510-857-5896
Submit a 510(k) for Device & 38780 Tyson Lane Suite 210 Fremont,
Software Changes CA-94536
LIVE WEBINAR
Date: Monday, 12 March 2018
Time: 10:00 AM PDT | 01:00 PM EDT
Early Bird Offer! Use Promo Code RECD10 to Get 10% off on Recorded
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Corporate Live Session/Super Combos of this webinar. Offer valid till Feb
18, 2018 midnight. Call us to know more.
[3][IMG] [4][IMG] [5][IMG] [10]instructor Carolyn Troiano
The U.S. FDA has published two Carolyn Troiano has
New Guidance Documents in October more than 35 years of
2017, "Deciding When to Submit a experience in the
510(k) for a Change to an pharmaceutical, medical
Existing Device", 1) on the device, tobacco and
device itself, and 2) on device other FDA-regulated
software. These documents attempt industries. She has
to provide companies tools to worked directly, or on
perform meaningful, results a consulting basis, for
driven 510(k) / change analysis many of the larger
activities. This is part of a pharmaceutical and
growing push by the Agency to tobacco companies in
strengthen the 510(k) process. the US and Europe,
The addition of simple tools will developing and
assist companies in implementing executing compliance
formal, documented, repeatable strategies and
methods with defensible rationale programs.
for their decisions on when one [11]View More
or several changes may require a Similar On-Demand Webinar
new 510(k) submission. This [12]FDA Regulation and Legislation
webinar will provide valuable of Cosmetics
assistance to all regulated [13]View More
companies performing and
documenting meaningful, results [14]NEW! SOP Library
driven 510(k) / change analysis
activities, based on the FDA's
two new Guidance documents on
510(k) Device and Software
changes. The new guidance will
provide manufacturers with a
greater understanding of the
FDA's expectations in the current
regulatory environment.
Key Learning Objectives
* Background on 510(k) device
modifications
* Important changes in device
and software modification
guidances
* Common software changes that
might require a 510(k) filing
* General guidance highlights
* Software guidance highlights
* Case study analysis on
instances requiring/not
requiring a new 510(k)
[6]View More
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