Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
January 29, 2014 Presentation to Compliance2Go webinar, focusing on:
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Who needs a CE mark and how do I get one? It is EU law that every product that enters the European Union meet the CE Directives and applicable Standards. This mark can only be applied to your product when you have fully complied with all relevant Directives and Standards for the type of system you are marketing and and a Declaration of Conformity has been developed.
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
This presentation provides a KEY for classifying In Vitro Diagnostic Devices per FDA and EU In-Vitro Diagnostic Regulation EU 2017/746
EU Conformity Assessment information is also provided
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
FDA Regulatory Considerations for Life Sciences CompaniesMichael Swit
April 2008 presentation to Swedish-American Chamber of Commerce Entrepreneurial Days on FDA issues for product development, including focus on:
Planning, approval process, barriers to entry
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
Premarket Notification The 510(k) ProcessMichael Swit
June 5, 2012 presentation to the Food & Drug Law Institute Introduction to Medical Device Law Conference, Palo Alto, CA, focusing on:
I.The Legal Framework For 510(k) Determinations
II.510(k) Preparation – From Planning to Content
A. Predicates: researching predicates, combination predicates, and pre-amendment predicates
B. Strategy: choosing the right claim and introducing new features
C. Assessing data requirements/pre-IDE meetings
III. Device Modifications - Choosing The Right Regulatory Mechanism
IV.The FDA Review
V.What To Do When Your Substantial Equivalence Argument Is Rejected
V. Special Topics: User Fees, Combination Products
VI. Lessons Learned: Seeing The 510(k) From The Reviewer’s Perspective
VII. Recent Trends, 510(k) Reform
VIII. Case Study
Successfully Responding to FDA Inspections (483s) & Warning LettersMichael Swit
November 10, 2015 webinar sponsored by Compliance2Go reviewing key issues and tactics associated with dealing with a company's reply to an FDA inspection and related warning letters. Includes lessons from actual responses.
Who needs a CE mark and how do I get one? It is EU law that every product that enters the European Union meet the CE Directives and applicable Standards. This mark can only be applied to your product when you have fully complied with all relevant Directives and Standards for the type of system you are marketing and and a Declaration of Conformity has been developed.
EMMA International Consulting Group CEO, Dr. Carmine Jabri, will be cohosting a webinar with Jan Flegeau, Director of Regulatory Affairs, to give an overview of what’s to come from the EU MDR.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
This presentation provides a KEY for classifying In Vitro Diagnostic Devices per FDA and EU In-Vitro Diagnostic Regulation EU 2017/746
EU Conformity Assessment information is also provided
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
FDA Regulatory Considerations for Life Sciences CompaniesMichael Swit
April 2008 presentation to Swedish-American Chamber of Commerce Entrepreneurial Days on FDA issues for product development, including focus on:
Planning, approval process, barriers to entry
Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for S...Michael Swit
Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Small Business Development Center (SBDC) @ UCI Applied Innovation
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
Clinical Trial Registries & Databases: An UpdateMichael Swit
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
Regulatory Considerations in Product DevelopmentMichael Swit
Presentation to the LARTA (www.larta.org) NIH-CAP Workshop in November 2011 on how to develop FDA-regulated products, with a focus on planning, working with FDA,
FDA Approval for Medical Devices: A Guide for Entrepreneurs | Jim Gustafson |...UCICove
About UCI Applied Innovation:
UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market.
About the Cove @ UCI:
To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts.
Follow us on social media:
Facebook: @UCICove
Twitter: @UCICove
Instagram: @UCICove
LinkedIn: @UCIAppliedInnovation
For more information:
cove@uci.edu
http://innovation.uci.edu/
Drug Safety: Perspectives on Industry's Duties in the Post-Vioxx Age.Michael Swit
Presentation to the Food & Drug Law Institute (FDLI) on Drug Safety with commentary on what are the emerging duties that industry may have to undertake in order to stay ahead of safety issues and avoid related products liability exposure.
This presentation covers the essential concept of ensuring all promotional communications are on label and the safe harbors established by FDA for disseminating off-label information compliantly.
Overview of FDA requirements for clinical studies as well as privacy issues, including impact of HIPAA; plus practical considerations in developing clinical studies.
The Application Integrity Policy (AIP): A Little History.Michael Swit
Presentation to the Food & Drug Law Institute Annual Enforcement, Litigation & Compliance Conference for the Drug, Device, Food, and Tobacco Industries. December 5, 2017. Washington, D.C.
GMP Review -- Legal Letter from America Column -- How Data Integrity Issues S...Michael Swit
Article appearing in the October 2018 issue of GMP Review by Michael A. Swit explores how data integrity issues sunk a $4.3 billion acquisition of Akorn by Fresenius. Article stresses lessons not just for quality professionals, but also their top management.
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Com...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 7: FTC RegulationMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 5: Social Media & InternetMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Action...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
FDA Regulation of Promotion & Advertising -- Part 3: Disseminating Scientific...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising --Part 2: Direct-to-Consumer AdsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices,November 1-2, 2018, Boston
FDA Regulation of Promotion & Advertising -- Part 1: The BasicsMichael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 1-2, 2018, Boston.
Regulatory, Quality & Clinical Due Diligence: The Oft Overlooked Keys to Suc...Michael Swit
June 23, 2010 webinar sponsored by The Weinberg Group, with an emphasis on key issues to explore during due diligence in acquiring FDA-regulated products or companies.
Presentation on Critical Legal Issues Facing GMP ComplianceMichael Swit
August 27, 2018 Presentation to the 23rd Annual GMP by the Sea Conference in Cambridge, Maryland, focusing on the potential legal consequences faced by companies that violate FDA's requirements on Good Manufacturing Practices (GMPs) for drugs and biologics
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
Latest Developments in and the Future of the Regulatory Landscape for Approv...Michael Swit
Presentation on "Latest Developments in and the Future of the
Regulatory Landscape for Approving Treatments
for Orphan and Rare Diseases," given at the Orphan Drugs & Rare Diseases -- 2018 Americas West Coast Conference.
June 25, 2018. San Diego, CA.
June 14, 2018 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course on the basics of FDA regulation of generic drugs and biosimilars.
Recent FDA Developments in Digital Health & Clinical Decision Support SoftwareMichael Swit
June 7, 2018 presentation at the 4th Annual Medical Device Summit, sponsored by ComplianceOnline, in San Francisco, focusing on the impact of the 21st Century Cures Act and other developments on how FDA regulates software in the medical device arena, including mobile medical applications.
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
Car Accident Injury Do I Have a Case....Knowyourright
Every year, thousands of Minnesotans are injured in car accidents. These injuries can be severe – even life-changing. Under Minnesota law, you can pursue compensation through a personal injury lawsuit.
How to Obtain Permanent Residency in the NetherlandsBridgeWest.eu
You can rely on our assistance if you are ready to apply for permanent residency. Find out more at: https://immigration-netherlands.com/obtain-a-permanent-residence-permit-in-the-netherlands/.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
Visit Now: https://www.tumblr.com/trademark-quick/751620857551634432/ensure-legal-protection-file-your-trademark-with?source=share
NATURE, ORIGIN AND DEVELOPMENT OF INTERNATIONAL LAW.pptxanvithaav
These slides helps the student of international law to understand what is the nature of international law? and how international law was originated and developed?.
The slides was well structured along with the highlighted points for better understanding .
ALL EYES ON RAFAH BUT WHY Explain more.pdf46adnanshahzad
All eyes on Rafah: But why?. The Rafah border crossing, a crucial point between Egypt and the Gaza Strip, often finds itself at the center of global attention. As we explore the significance of Rafah, we’ll uncover why all eyes are on Rafah and the complexities surrounding this pivotal region.
INTRODUCTION
What makes Rafah so significant that it captures global attention? The phrase ‘All eyes are on Rafah’ resonates not just with those in the region but with people worldwide who recognize its strategic, humanitarian, and political importance. In this guide, we will delve into the factors that make Rafah a focal point for international interest, examining its historical context, humanitarian challenges, and political dimensions.
Abdul Hakim Shabazz Deposition Hearing in Federal Court
FDA Regulation of Advertising of Diagnostics, RUO Products, and Laboratory Developed Tests
1. FDA Regulation of Advertising
of Diagnostics, RUO Products, and
Laboratory Developed Tests
Michael A. Swit, Esq.
Managing Principal
Law Offices of Michael A. Swit
LAW OFFICES OF MICHAEL A. SWIT
2. Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• These slides are intended to provide general
educational information and are not intended to
convey legal advice.
LAW OFFICES OF MICHAEL A. SWIT2
3. The Diagnostic Playing Field
• “Pure” In Vitro Diagnostics – PMA or 510(k)
• Laboratory Developed Tests (LDTs) – CLIA
regulated
• RUO products
– FDA: “diagnostic in training” –
• 21 CFR 809(c)(2)(i) -- For a product [in vitro diagnostic] in the
laboratory research phase of development, and not represented as an
effective in vitro diagnostic product, all labeling bears the statement,
prominently placed: "For Research Use Only. Not for use in diagnostic
procedures.”
– But – if intended use is not diagnostic, how can it be a
diagnostic?
3 LAW OFFICES OF MICHAEL A. SWIT
5. RUO Claims – General Principles
• Focus on the use of the product for research
– Use:
• Statements that refer to discovery or further development of novel and fundamental
medical knowledge related to human disease and conditions.
– Caveat: statements should accurately reflect the current state of research and, if
possible, will be supported by citing to specific peer-reviewed publications.
• Future looking statements – it is acceptable to talk about using an RUO product
to diagnose disease if … you make clear that you are talking about doing so in the
future.
– Example:
» “With CancerRUO as a building block, oncologists may soon have new
diagnostics for previously undetectable cancers.”
5 LAW OFFICES OF MICHAEL A. SWIT
6. RUO Claims – General Principles …
• Focus on use of the product for research
– Eliminate:
• statements that could be construed to mean that the product can be used to screen for, cure,
mitigate, treat, or diagnose any disease or disorder in humans.
Examples:
– “With CancerRUO, Dr. Swanson diagnosed chronic myeloid leukemia in a 50-
year old Baltimore woman.”
– “Sequencing on a SanzoSeq can allow you to more cheaply detect infectious
diseases in your patients.”
• clinical performance claims, clinical information, product names, or descriptors that
claim or suggest that the product can be used in a clinical investigation, for any clinical
diagnostic use, or to manage human health.
Example:
– “DiagSeq™, the new palm size next-generation sequencer for diagnosing your
patients.” – what 3 things are not RUO here?
6 LAW OFFICES OF MICHAEL A. SWIT
7. RUO Claims – General Principles …
• Focus on use of the product for research
– Eliminate:
• Statements that suggest that clinical laboratories can validate the product through their
own procedures and offer the product for diagnostic use as an LDT
• “Clinical” statements such as:
– Clinical interpretative information
– discussion of clinical significance
– other indications of clinical applicability
IN SHORT, avoid the word “clinical”
• Statements regarding the sensitivity or specificity of an assay. Those terms are
considered to be diagnostic in nature.
• You may comment on the analytical performance of an RUO assay.
7 LAW OFFICES OF MICHAEL A. SWIT
8. RUO – Acceptable Claims
• Research or research use
– “clinical research” is acceptable if both words are used together and the context
makes clear that it is not for IUO/investigational or IVD/diagnostic purposes.
• Feasibility
• Analytical performance
• Scientific or analytical terminology.
Examples:
Variants
CNVs
SNPs
• Subject (not “patient”)
8 LAW OFFICES OF MICHAEL A. SWIT
9. RUO – Acceptable Claims …
• Verbs:
– Analyze
– Assess
– Explain
– Research
– Review
– Study
– Capture
– Detect – but only with a genetic/non-disease term such as “variant” or
“indel”
9 LAW OFFICES OF MICHAEL A. SWIT
10. RUO – Unacceptable Claims
• Clinical
• Diagnostic
• Patient
• Actionable
• Sensitivity and Specificity
– these terms used without “analytical” imply clinical measures determined by a well-
controlled clinical study
• Verbs – especially if used with any disease or disorder name (but,
acceptable, if used with “variant, SNP, indel”):
– Detect -- Monitor -- Target
– Manage -- Identify
– Diagnose -- Screen
10 LAW OFFICES OF MICHAEL A. SWIT
11. The RUO Statement
• FDA Regulations – must be “prominently placed” on all
RUO labeling
• Recommendation: Must appear any time a RUO product is
– Named
– Pictured, or
– “Otherwise depicted” (e.g., screenshot from an RUO software)
– Obviously being discussed
• Full statement -- to be used always in Ad/Promo:
– “For Research Use Only. Not for use in diagnostic procedures.”
• Punctuated and capitalized precisely as above
• “RUO” or “For Research Use Only” – not acceptable
11 LAW OFFICES OF MICHAEL A. SWIT
12. IVD Claims – General Principles
• Must be “on-Label” -- all statements made about IVD products must:
– Be consistent with the product’s cleared or approved labeling; and
– Not go beyond that labeling.
• Note: Verbatim use of the product’s intended use statement is
required.
• Example: if an IVD is regulated by FDA for “screening”
only, you can’t say “diagnose”
• Must include this statement:
– “ For In Vitro Diagnostic Use”
12 LAW OFFICES OF MICHAEL A. SWIT
13. IVD Claims – Unacceptable Claims
• Off-label claims –
– any safety, effectiveness or other claim that either is clearly not already in
the labeling for the product or expands an existing claim beyond that
which is in the labeling, including use with an instrument that is not clearly
in the product labeling.
• Adding, deleting, or changing process steps relating
to a Dx product.
• Claims that go beyond the capabilities of our
products
13 LAW OFFICES OF MICHAEL A. SWIT
14. IVD Claims – Unacceptable Claims
Lacking Fair Balance – FDA expects that risk and benefit information for
medical devices be presented in a balanced fashion and devotes great attention
to reviewing Ad/Promo to ensure industry Ad/Promo reflects such balance.
2009 -- FDA issued a guidance document that captures the agency’s views of
what constitutes “fair balance” in promotional copy and labeling.
Marketers should review the guidance with care as compliance with it best
assures that FDA will not raise questions on how an Ad/Promo piece for a
diagnostic balances risk and benefit.
The guidance can be accessed at:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances
/ucm155480.pdf
14 LAW OFFICES OF MICHAEL A. SWIT
15. LDT Claims – General Principles
• Must be “on-Label” -- all statements must be:
– consistent with the product’s labeling; and
– may not go beyond the use developed under the appropriate regulations or
standards governing the LDT.
• Example:
– Verifi® LDT -- the following statement appears in conjunction with
the first mention of Verifi in an Ad/Promo piece:
The Verifi® test was developed by, and its performance characteristics were
determined by Verinata Health, Inc. (VHI), a wholly owned subsidiary of Illumina,
Inc. The VHI laboratory is CAP-accredited and certified under the Clinical
Laboratory Improvement Amendments (CLIA) as qualified to perform high
complexity clinical laboratory testing. It has not been cleared or approved by the
U.S. Food and Drug Administration.
15 LAW OFFICES OF MICHAEL A. SWIT
16. LDT Claims – Acceptable
• Exact definition and indication of the test
• Actual data generated using the test
• May compare to other laboratories LDT’s with
same indications (e.g., compare validation studies)
so long as the comparisons are accurate and
adequately substantiated (per FTC standards)
16 LAW OFFICES OF MICHAEL A. SWIT
17. Companion Diagnostics -- Logistics
• Coordination – is key with drug/biologic maker to
whom you are the companion
– Joint review committee/processes – nail these down in the
future
– Plan for challenges
17 LAW OFFICES OF MICHAEL A. SWIT
18. Questions?
• Call or e-mail:
Michael A. Swit, Esq.
LAW OFFICES OF MICHAEL A. SWIT
San Diego, California
m: 760-815-4762
e: mswit@fdacounsel.com
web: www.fdacounsel.com
• Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
LAW OFFICES OF MICHAEL A. SWIT18
19. About Your Speaker
Michael A. Swit, Esq., has been addressing critical FDA legal and regulatory issues since
1984. Before returning to private law practice in late 2017, he served for 3 years at Illumina, Inc. as
Senior Director, Legal, Regulatory. Prior to that, Swit was a special counsel at the global law firm of
Duane Morris LLP in its San Diego office. Before joining Duane Morris in March 2012, Swit served
for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory
consulting firm in the Life Sciences. His expertise includes product development, compliance and
enforcement, recalls and crisis management, submissions and related traditional FDA regulatory
activities, labeling and advertising, and clinical research efforts for all types of life sciences companies,
with a particular emphasis on drugs, biologics and therapeutic biotech products. His FDA legal and
regulatory work also has included tenures in private practice with McKenna & Cuneo (now Dentons)
and Heller Ehrman, and as vice president, general counsel and secretary of Par Pharmaceutical, a top
public generic and specialty drug firm. He also was, from 1994 to 1998, CEO of FDANews.com, a
premier publisher of regulatory newsletters and other specialty information products for FDA-
regulated firms. He has taught and written on many topics relating to FDA regulation and associated
commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned
his A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory
University.
19 LAW OFFICES OF MICHAEL A. SWIT