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Keynote Address: Practical Case
Considerations and Interactions with Your
Local FDA Compliance Branch – Yesterday,
Today and Tomorrow
IVT’s 22nd Annual Validation Week
Coronado Island, CA [Oct. 18-20, 2016]
Dr. Raymond W. Brullo, DPM
FDA Compliance Officer/Investigator
Doctor of Podiatric Medicine
FDA Los Angeles District Office, Irvine, CA
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Disclaimer
The following slides and presentation by
me, Dr. Raymond W. Brullo, are my own
views. There is no implication that they are
the views of the Agency/FDA.
Quoting of my presentation, in whole or in
part in any format [e.g. social media or
other media not included in the provisions
of the sponsor brochure], is prohibited.
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Keynote Address – Defined @
Merriam Webster
An address designed to present the
issues of primary interest to an
assembly (as a political convention)
and often to arouse unity and
enthusiasm —called also keynote
speech
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Agenda/Objectives
Part 1: a sampling of regulatory and enforcement actions & how to respond to the District and Compliance Officer – some logistics
Part 2: public accessible documents –what’s been said and occurred [2004-present] & the regulatory continuum – past, present, and future – reality and projections
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Brullo presentation to ASQ, August 2012
Warning Letter to Albert Browne Ltd., Leicester,
UK [29-May-12]
These violations include, but are not limited to, the
following:1. Failure to establish and maintain
adequate procedures for validating the device
design, as required by 21 CFR 820.30(g). For
example, acceptance criteria were not established
prior to the performance of validation activities
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Brullo presentation to ASQ, August 2012
Civil Money Penalties
FDA reached $1 million settlement with
Pennsylvania medical device firm
Firm had marketed its device without the
proper premarket approval or clearance
$550,000 penalty to the firm with $450,000
penalty to the firm’s CEO
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People, Time and Money
Need All Three to Correct and Prevent
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What should you do if you get a
regulatory action?
Top Management must be advised
Act promptly… this could be the start, not
the end, and escalate to enforcement action
Respond as completely as possible, usually
to the Director, LOSDO Compliance
Branch. Caveat: in practical terms, the case
will be linked to a local Compliance Officer
who will be the reviewer and point person.
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Requesting a Meeting with the District
Office
A meeting is usually, but not always, requested by
a firm to provide an overview of the company’s
commitment and progress [corrective actions,
management perspective]
Typically there is a PowerPoint presentation and
colorful handouts. The District is under no
obligation to agree to such a meeting
Benefit: to show “good faith” and present a “face”
to the District
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When a Meeting is a Regulatory Meeting (e.g.
“reg meeting”) (Prior Notice)
Anything can be discussed including past history,
current deficiencies, and violations so be prepared
with documented evidence of corrective actions.
Be prepared to provide a timetable for next steps
and specific commitments towards realistic
corrective and preventive actions.
Post-reg meeting, stay in touch with the CO and
provide clear, organized responses
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Los Angeles District Office – Compliance
Branch – Connections…Current
District Director
Investigations Branch Director
Investigators
Consumer Complaints
Compliance Branch Director
Compliance Officers
Recalls
Director, Pacific Regional Laboratory
Southwest
Directors, Microbiology Branch Chemistry
Branch
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How to Interact with the Local Compliance
Branch and Officer (Correspondence)
Typically, written correspondence, perhaps with
disk, via overnight carrier
Hand-delivery: firm may try to solicit a quick
“meeting” and also serves as “good faith” and
assurance of delivery to District
Email: it can be printed off and then uploaded to
specific FDA databases. But, if it has large e-files,
written correspondence is preferred or provided
additionally
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How to Interact with the Local Compliance
Branch and Officer
Do tab responses so that included evidence is
clearly marked and referenced in the general
narrative of the response. Do provide a table of
projected corrective actions and anticipated dates
of completion
Telephone call(s) if indicated - limit
Don’t circumvent the CO via the Investigator,
Director of Compliance, or other management as
the CO is following the case day-to-day
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How to Interact with the Local Compliance
Branch and Officer
Do not rely on requests for response
extensions, especially to the FDA-483
Be careful when having a consultant or
attorney speak for you. You are still
responsible; particularly, at the follow-up
inspection
Enforcement: let your attorney and FDA,
DOJ attorneys work things out
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Part 2: Regulatory: Past, Present, Future
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FDLI Litigators Conference 2005 –
Enforcement Policy
Cooperative and educational efforts
Fair, risk-based, scientifically sound principles to assure efficient enforcement
Risk-based approaches to inspection, compliance, and enforcement activities using available enforcement tools commensurate with
violations, or
relying on voluntary action as appropriate
Punish violations of fraud, gross negligence, or intentional violations and deter others through action
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FDLI Litigators Conference 2005 –
Enforcement Policy
Collaborate and cooperate with federal,
state, local, foreign governments,
international organizations
Evaluate and improve programs
Assure quality in all work products while
meeting productivity expectations
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FDLI Litigators Conference 2005 –
Enforcement
Risk management principles
Assess the Violations
Analyze the Violations
Consider the Desired Outcome
Optimize the Compliance or Enforcement Decision
Pursue the Decision with Vigor
Use enforcement resources wisely to achieve effective and efficient compliance
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FDLI Litigators Conference 2005 – What
Can Industry Do?
Continue to innovate and develop products
that advance public health
Demonstrate a corporate philosophy of
compliance
Pay attention to signals
Be forthright and proactive
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FDA Inspection Summit, October 2008
Increase in Numbers of Recalls 4,804 recalls (FY2008) vs. 3,625 recalls (FY1997)
Decrease in Consumer Confidence
April 2007 Harris Interactive Survey
Various Outbreaks or Safety Warnings
Significant Attrition within FDA
New Initiatives and Legislation
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FDA Inspection Summit, October 2008 –
What Should be Counted as a Compliance
Action?
Recalls (State & FDA) Emergency Permits
Regulatory Meetings Guidance Documents
Certain Press Releases Import Actions
FR Notices Education/Outreach
“Untitled” Letters FDA 483s
Inspections State Actions
Voluntary actions
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Commissioner…2009 speech to
Food and Drug Law Institute
“…in order to have an effective
enforcement strategy that protects the public
health, “the agency must be able to respond
rapidly to egregious violations or violations
that jeopardize the public health.” The
Commissioner hoped that “in the future,
effective FDA enforcement actions will not
be surprising…or out of the ordinary.”
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June 2009 Commissioner launched the
FDA Transparency Initiative
In January, 2010, as part of phase I of the
Transparency Initiative, FDA launched a
web-based resource, FDA Basics
(www.fda.gov/fdabasics), to provide basic
explanations about FDA’s work
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Device Trends and Challenges, 2010
Implement total life-cycle review
and comprehensive 510(k) review
Increased post market surveillance
program
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ORA, Chief Counsel, and Center compliance
offices joint statement…July 15, 2010
“All FDA components are
committed to swift, aggressive
enforcement actions to protect
the public health.”
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MDIC Strategy: Create a Public-Private
Partnership between Industry, FDA and Non-
profits (2012 and 2016)
Align Resources: Working cooperatively with
FDA to re-engineer pre-competitive technology
innovation
Accelerate Progress: Reducing the time and
resources needed for new technology
development, assessment, and review
Achieve Results: Helping patients benefit by
gaining access to new medical technologies sooner
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2012/2013 LOSDO and Orange County DA’s Office
Unapproved medical device – hair growth
laser/low level red lights
LOSCB Warning Letter for lack of 510(k) and
cGMPs. FDA seizure action not supported as
State of CA had embargo in place
2015-2016: Although firm obtained a 510(k),
Orange Country DA developed case resulting in
consent decree and monetary penalties
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Reviewing FDA’s Implementation of
FDASIA, November 15, 2013
Final rule for a Unique Device Identification
(UDI) System
Re-issue of a draft IDE guidance
Streamlining of the de novo pathway
Stakeholder input re modification to a 510(k)-
cleared device
Class III Preamendment Devices – process change
Humanitarian Device Exemption – modified
provision29
FDANews Inspections Summit
October 24, 2014
Program Alignment Initiative – functional and
operational change – optimize coordination;
strengthen accountability; reduce duplication
Increased technical expertise; work with subject
matter experts in Centers
Risk-based inspection approach with metrics
Case for Quality: quality; data; stakeholders
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International Medical Device Regulatory
Forum - Medical Device Single Audit
Program, 2014
Global approach to auditing and monitoring
the manufacturing of medical devices
Provides confidence in program outcomes
Third Parties and Regulatory Inspectorates
Oversight of Regulatory Authorities
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International Programs, @fda.gov, 2016
CDRH commitment to assuring patients and
providers have timely and continued access to
safe, effective and high-quality medical devices
CDRH engages with foreign medical authorities
CDRH exchanges information through web-based
training, scientific and policy discussions and
confidentiality commitments
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FDA Program Alignment Medical Devices
and Radiological Health FY2016 Action Plan
Transition to Commodity-Based and Vertically
Integrated Regulatory Program (Specialization)
Training and Certification
Medical Devices and Radiological Health
Program Work Planning
Quality Policy and Strategy
Imports
Laboratory Optimization
IT33
Medtech Insight – September, 2016
Park Prosecutions Are Expected To Continue
2015 memo from US Deputy Attorney General
Misdemeanor convictions of two former execs at
J&J unit
Thorough internal review and policies/procedures
that ensure transparency
Senior management can show they tried to avoid
violations
Schedule opportunities to present concerns to
management
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CDRH: Narrative by Activity, @ 2016-2017
Priorities are to: Establish a National Evaluation
System for Medical Devices; Partner with
Patients; Promote a Culture of Quality and
Organizational Excellence
Improve and streamline access
Guidances
Product Approvals
Clinical Trial Enterprise
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CDRH: Narrative by Activity, @ 2016-2017
Early Feasibility Studies
Expedited Access Program
Patient Preference Initiative
Patient Engagement Advisory Committee
Medical Device Innovation Consortium
Next Generation Sequencing
Experiential Learning Program
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CDRH: Narrative by Activity, @ 2016-2017
CDRH Learn
Customer Service
Enhance Oversight
Medical Device Reporting
Medical Product Safety Network
National Medical Device Evaluation System
Unique Device Identification
Registry Based Surveillance
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CDRH: Narrative by Activity, @ 2016-2017
Signal Management Program
Case for Quality Initiative
Voluntary Compliance Improvement Pilot
Program
Medical Device Single Audit Program
Digital Health Program
Radiological Health Program
Mammography Quality Standards Act Program
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CDRH: Case for Quality
(@www.fda.gov, 2016)
Focus on Quality
Enhance Data Transparency
Stakeholder Engagement
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2016-2017 Strategic Priorities
Center for Devices and Radiological Health
Establish a National Evaluation System for
Medical Devices
Partner with Patients
Promote a Culture of Quality and
Organizational Excellence
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2016-2017 Strategic Priorities
Center for Devices and Radiological Health
http://www.fda.gov/downloads/AboutF
DA/CentersOffices/OfficeofMedicalPr
oductsandTobacco/CDRH/CDRHVisio
nandMission/UCM481588.pdf
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Bonus Reminder! CDRH Learn!
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Bonus Reminder! Medical Device
Webinars and Stakeholder Calls!
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Dr. Raymond W. BrulloCompliance OfficerDoctor of Podiatric MedicineLos Angeles District [email protected]
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