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
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.
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.
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.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
January 29, 2015 webinar sponsored by Compliance2Go, with a focus on:n the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
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
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.
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.
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.
Alternative Approaches to FDA Approval for Drug and Device FirmsMichael Swit
January 29, 2015 webinar sponsored by Compliance2Go, with a focus on:n the various approaches to drug and device approval/marketing that differ from standard method, including:
* accelerated approval
* breakthrough therapies
* fast track drugs
* priority review
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
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.
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.
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 3: Disseminating Scientifi...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, March 22, 2018
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
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
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
Review of the de novo 510(k) Petition process that allows for the reclassification of innovative devices that are automatically placed into Class III by FDA.
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.
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 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, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actio...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, March 22, 2018
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
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.
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
Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
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
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.
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.
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 3: Disseminating Scientifi...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, March 22, 2018
What’s In a Name? FDA and Non-Proprietary Names for Biologics/BiosimilarsMichael Swit
April 20, 2018 Presentation to the 11th Biosimilars & Follow-On Biologics 2018 Americas conference on FDA's Policy on Non-proprietary names for Biosimilars
Presentation at ACI Conference on FDA Enforcement, covered:
Warning Letters, FDA Case Referral Process/Role of DOJ and U.S. Attorney, Coordination with States, Collateral Consequences of FDA Enforcement Actions
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
The De Novo 510(k) Process - Is There Hope at FDA for Lower Risk Innovative D...Michael Swit
Review of the de novo 510(k) Petition process that allows for the reclassification of innovative devices that are automatically placed into Class III by FDA.
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.
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 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, March 22, 2018
FDA Regulation of Promotion & Advertising -- Part 4: FDA Enforcement – Actio...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, March 22, 2018
FDA Enforcement & Compliance for Medical DevicesMichael Swit
Presentation to the Food & Drug Law Institute (FDLI) Introduction to Medical Device Law, with a focus on:
* FDA Jurisdiction to Enforce
* Prohibited Acts and Penalties
* Inspections – FDA’s Prime Enforcement Tool
* Other “Cops on the Beat”
* Commissioner Hamburg’s Enforcement Initiative
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.
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
Generic Drug Labeling Proposed Rule: The Generic Drug Industry PerspectiveMichael Swit
May 15, 2014 webinar sponsored by the Drug Information Association (DIA) on the November 2013 FDA proposed rule to require generic drug firms to amend their labels with new safety information even if the brand name label has not been changed with the same information.
FDA Regulation of Advertising and Promotion -- the BasicsMichael Swit
Presentation to the November 9-10, 2017 Course sponsored by ComplianceOnline, in Boston, MA, focusing on the basics of FDA regulation of drug and device advertising.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
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, March 22, 2018
The basics of medical device labeling usa fda regulations-by-costas-chantzisCostas Chantzis
The Basics of Medical Device Labeling - USA FDA Regulations:
What You Must Know To Improve Your Chances of NOT Getting Your Company In Trouble with the FDA ...
FDA Trends in Medical Device ComplianceMichael Swit
Presentation to the Joint American Bar Association (ABA)/Medical Device Manufacturers Association (MDMA) Conference, on December 11, 2014, in Washington, D.C.. Slides focus on:
• Major Initiatives –
– Inspection Realignment
– Reporting of Corrections Guidance
• FDA Inspections –Key Observations in Device Inspections
• Marketing & Social Media –
– Intended Use Creep --Aegerion
– Space Limitation Guidance
• HHS Exclusion for FDA Violations –the Curious Case of the Purdue Pharma Executives
New legal obligations and liability under MDR and IVDRErik Vollebregt
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Presentation delivered at the RMD 2016 conference (European Symposium on the New Agreed Draft Regulations on Medical Devices) in Prague on 7 November 2016
In this presentation we want to outline the principles of medical device regulations and the 510(k) Premarket notification process for an efficient product approval with the FDA.
Breakout Session: Cybersecurity in Medical DevicesHealthegy
Presentation by PwC at Medtech Conference 2016.
Participant:
Geoff Fisher, Director – PwC
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
This presentation looks at some of the unique considerations in developing mobile programs, especially apps. A significant amount of the presentation is dedicated to elucidating and expanding on the FDA's recently finalized guidance regarding mobile medical apps.
COVID-19 and the FDA: What Every Manufacturing Company Needs to KnowEMMAIntl
Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar to learn more about FDA’s temporary policies for regulating Personal Protective Equipment (PPE), Reprocessing, Ventilators and Hand Sanitizer manufacturing, and what you need to do to get your product on the market.
Device registration and listing of medical devices on the US marketttopstart B.V.
We provide an overview of the regulations and legislations with regard to commercialisation of medical devices in the US. The product category of medical devices ranges from class I devices up to class III devices. In the US, market approval is granted by the FDA (Food and Drug Administration) upon assessment of quality, safety and effectiveness.
The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulatory procedures for specific classes of medical devices. By summarising the procedures for each class of medical device, we, ttopstart, aim to offer a guide through this dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.
Guidance for Industry and Food and Drug Administration Staff: Mobile Medical ...CRF Health
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and
potential functions of mobile apps, the rapid pace of innovation in mobile apps, and the potential
benefits and risks to public health represented by these apps. The FDA is issuing this guidance
document to inform manufacturers, distributors, and other entities about how the FDA intends to
apply its regulatory authorities to select software applications intended for use on mobile
platforms (mobile applications or “mobile apps”). Given the rapid expansion and broad
applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority.
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 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 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
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.
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.
FDA Inspections: Handling the Consequences -- or Understanding How Ugly It C...Michael Swit
Presentation to the MAGI Clinical Research Conference – 2018 East, given on May 22, 2018 in Arlington, Virginia, and focusing on the collateral consequences of negative FDA inspections in the clinical research arena
FDA Regulation of Promotion & Advertising -- Part 8: Handling Promotional Co...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, March 23, 2018
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-La...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, March 23, 2018
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, March 22, 2018
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, March 22, 2018
Responsibilities of the office bearers while registering multi-state cooperat...Finlaw Consultancy Pvt Ltd
Introduction-
The process of register multi-state cooperative society in India is governed by the Multi-State Co-operative Societies Act, 2002. This process requires the office bearers to undertake several crucial responsibilities to ensure compliance with legal and regulatory frameworks. The key office bearers typically include the President, Secretary, and Treasurer, along with other elected members of the managing committee. Their responsibilities encompass administrative, legal, and financial duties essential for the successful registration and operation of the society.
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
Synopsis On Annual General Meeting/Extra Ordinary General Meeting With Ordinary And Special Businesses And Ordinary And Special Resolutions with Companies (Postal Ballot) Regulations, 2018
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/.
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.
Basics of FDA Regulation of Device & IVD Advertising
1. Basics of FDA Regulation of
Device & IVD Advertising
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. Who Has Jurisdiction …
• Restricted Devices
– Labeling -- FDA
– Advertising – FDA
• “Unrestricted Devices”
– Labeling -- FDA
– Advertising – Federal Trade Commission
3 LAW OFFICES OF MICHAEL A. SWIT
4. Who Has Jurisdiction …
• Internet – is it labeling or advertising?
– Eye of beholder?
– FDA has asserted that it can regard as labeling web sites for
products such as OTC drugs and dietary supplements that
the agency does NOT have jurisdiction over advertising
4 LAW OFFICES OF MICHAEL A. SWIT
5. Restricted Devices -- Misbranding
• Section 502(q) -- In the case of any restricted
device distributed or offered for sale in any State, if
:
– (1) its advertising is false or misleading in any
particular, or
– (2) it is sold, distributed, or used in violation of
regulations prescribed under section 520(e) of this title
[i.e., a regulation restricting sale of device]
5 LAW OFFICES OF MICHAEL A. SWIT
6. Brief “Statement” for Restricted Devices
– Section 502(r) and Advertising
• Device is Misbranded … unless the manufacturer,
packer, or distributor thereof includes in all
advertisements and other descriptive printed matter
issued or caused to be issued by the manufacturer, packer,
or distributor with respect to that device
– (1) a true statement of the device's established name as defined in
subsection (e) of this section, printed prominently and in type at
least half as large as that used for any trade or brand name
thereof, and
• ….continued …
6 LAW OFFICES OF MICHAEL A. SWIT
7. Section 502(r) – Device “Brief
Statement” …
– (2) a brief statement of the intended uses of the device and relevant
warnings, precautions, side effects, and contraindications and,
• in the case of specific devices made subject to a finding by the Secretary
after notice and opportunity for comment that such action is necessary to
protect the public health, a full description of the components of such
device or the formula showing quantitatively each ingredient of such
device to the extent required in regulations which shall be issued by the
Secretary after an opportunity for a hearing.
• .. continued …
7 LAW OFFICES OF MICHAEL A. SWIT
8. 502(r) – Devices “Brief Statement”
• Except in extraordinary circumstances, no regulation issued under
this paragraph shall require prior approval by the Secretary of the
content of any advertisement and no advertisement of a restricted
device, published after the effective date of this paragraph shall, with
respect to the matters specified in this paragraph or covered by
regulations issued hereunder, be subject to the provisions of sections
12 through 15 of the FTC Act.
• This paragraph shall not be applicable to any printed matter which the
Secretary determines to be labeling as defined in section 321(m) of this
title.
8 LAW OFFICES OF MICHAEL A. SWIT
9. Device Advertising Regulations
• Marketed Devices –no separate device advertising
regulations as in 21 CFR 202.1
• Center for Devices & Radiological Health
(CDRH), compared to its drug counterparts --
relatively inactive in ad enforcement –
9 LAW OFFICES OF MICHAEL A. SWIT
10. Device Advertising – Warning Letters …
• Warning Letters – just 27 between 2001 and today
• Source: Warning Letter search: “device
advertising” and “device promotion”
– http://www.accessdata.fda.gov/scripts/warningletters/wlSea
rchResult.cfm?webSearch=true&qryStr=device+advertising
10 LAW OFFICES OF MICHAEL A. SWIT
11. Devices – Intended Uses
• “Ordinarily, intended use is determined by reference to
'labeling' or promotional claims; only in rare cases might
it be necessary to infer intended use from other types of
information.”
– Source: ODE Blue Book Memorandum #K86-3 entitled Guidance on
the Center for Devices and Radiological Health's Premarket Notification Review
Program [Hot Link]
• Issue – relative to off-label promotion issues
• FDA – can inhibit off-label use, via statute, in clearing a
510(k) under Section 513(i)(1)(E), which provides …
• … continued …
11 LAW OFFICES OF MICHAEL A. SWIT
12. 513(i)(1) (E) – 510(k) Restrictions
on Off-Label Promotion
• Sub-sub paragraph (i) -- FDA -- may require a statement
in labeling that provides appropriate information regarding
a use of the device not identified in the proposed labeling
if, after providing an opportunity for consultation with the
person who submitted such report, the Director
determines and states in writing—
– (I) that there is a reasonable likelihood that the device will be used for an
intended use not identified in the proposed labeling for the device; and
– (II) that such use could cause harm.
12 LAW OFFICES OF MICHAEL A. SWIT
13. 513(i)(1)(E) – 510(k) -- Off-Label
Restrictions …
• (ii) Such determination shall—
– (I) be provided to the person who submitted the report within 10 days
from the date of the notification of the Director's concerns regarding
the proposed labeling;
– (II) specify the limitations on the use of the device not included in the
proposed labeling; and
– (III) find the device substantially equivalent if the requirements of
subparagraph (A) are met and if the labeling for such device conforms to
the limitations specified in subclause (II).
• (iii) The responsibilities of the Director under this subparagraph may not be
delegated.
13 LAW OFFICES OF MICHAEL A. SWIT
14. 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. SWIT
15. 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.