Presentation to the Drug Information Association (DIA) Annual Meeting, June 26, 2013, focusing on:
* Development of de novo concept
* FDAMA changes
* FDA guidances
Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices.
Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including:
-Requirements for software development as outlined in IEC 62304
-Content considerations for premarket submissions
-Human factors engineering as a platform for enhanced user safety
-Provisions for data security and protection against unauthorized wireless access
We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
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
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...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/
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
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
Slides presented at "Getting Your Medical Device FDA Approved" event, presented by Mentor Graphics Embedded Software, discussing how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices.
Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for Medical devices. During this session we discussed how FDA hot buttons affect your medical device submission will be discussed, including:
-Requirements for software development as outlined in IEC 62304
-Content considerations for premarket submissions
-Human factors engineering as a platform for enhanced user safety
-Provisions for data security and protection against unauthorized wireless access
We reviewed the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.
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
FDA Regulations and Medical Device Pathways to Market | Kevin Daly | Lunch & ...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/
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
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
Poster Presentation - FDA Compliance Landscape & What it Means to Your AI Asp...CitiusTech
CitiusTech delivered a poster presentation on the FDA compliance landscape (PMA, De Novo, 510k and Pre Cert) and its implication on AI in Healthcare, at the Mayo Clinic AI Symposium earlier this year.
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
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
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.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
FDA Legal & Regulatory Considerations for Biomedical StartupsMichael Swit
Presentation to the Tech Coast Angels on key legal and regulatory considerations for biomedical (drug and device) start-up companies, given on March 7, 2003.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
The “De Novo” 510(k) Process and the Reclassification of Class III DevicesMichael Swit
September 30, 2005 presentation to the Medical Device Manufacturers Association (MDMA) 510(k) Workshop, in Burlington, MA, with a focus on how the de novo process evolved, challenges faced by those seeking to pursue it, and how it has evolved since FDAMA.
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.
Poster Presentation - FDA Compliance Landscape & What it Means to Your AI Asp...CitiusTech
CitiusTech delivered a poster presentation on the FDA compliance landscape (PMA, De Novo, 510k and Pre Cert) and its implication on AI in Healthcare, at the Mayo Clinic AI Symposium earlier this year.
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
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
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.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
FDA Legal & Regulatory Considerations for Biomedical StartupsMichael Swit
Presentation to the Tech Coast Angels on key legal and regulatory considerations for biomedical (drug and device) start-up companies, given on March 7, 2003.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
Many emerging companies make the mistake of putting all of their resources into immediate needs, and often neglect longterm regulatory strategy concerns when it comes to submissions and approvals. Don’t neglect the strategy piece in your planning! This lunch will provide a deep-dive foundation of how to develop a regulatory strategy. Topics to be addressed include:
What are different types of regulatory submissions for devices?
What are current trends in regulatory agencies?
What regulations around devices affect your organization?
Attendees will have the opportunity to ask questions with their company’s needs in mind.
Join us and Halloran Consulting at M2D2 for this expert lunch. Food will be served.
The “De Novo” 510(k) Process and the Reclassification of Class III DevicesMichael Swit
September 30, 2005 presentation to the Medical Device Manufacturers Association (MDMA) 510(k) Workshop, in Burlington, MA, with a focus on how the de novo process evolved, challenges faced by those seeking to pursue it, and how it has evolved since FDAMA.
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.
Using Clinical Studies to Support Claims for 510(k) Devices. Michael Swit
Presentation to the Regulatory Affairs Professionals Society (RAPS) Advertising, Promotion and Labeling Conference, May 2, 2006, Denver, with a focus on:
• Clinical Literature to Support Claims in Labeling and Advertising –FDA’s Views
• Clinical Investigations–using to Support Claims in Labeling and Advertising
• “Intended Use”–the Lynchpin of Device Promotional Analysis vis-à-vis Clinical Studies
• Case studies --Advertising/Promotional Claims Impacted by Deviations from Intended Use
• A Final Word of Caution –Be Careful if You Are Publicly Traded on what you say on clinicals
FDA Regulatory Considerations for the Biomedical Start-upMichael Swit
October 7, 2005 presentation to the LARTA CAP program in Newport Beach, CA, focusing on:
* 3 key roles of FDA
* tips for the unwary
* regulatory definitions
* submission types
* data required for approval
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Medical Device Advertising Law & RegulationMichael Swit
Presentation to the IVT Medical Device Conference. San Francisco. August 17, 2006. Talk focused on:
Basics of the Law
Regulation of Promotion/Advertising
Off Label Promotion & the First Amendment
Other Legal Concerns Impacting Advertising
The AdvaMed Code
Medical Device Advertising Law & RegulationMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference in San Francisco, CA, focusing on:
* Basics of the Law
* Regulation of Promotion/Advertising
* Off Label Promotion & the First Amendment
* Other Legal Concerns Impacting Advertising
* The AdvaMed Code
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
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
Medical device as per india and usa special reference with 510(k)vikash vyas
1. medical device as per usa:
a) classification
b) 510(k)
c) 510(k) submission process
d) pre market approval(PMA)
2. medical device as per india
a) definition
b) organization of medical device reviewer
c) registration process
d) document required for the registration of medical device as per cdsco
Keynote presentation at the Skin Summit, sponsored by Pharmaceutical Education Associates, in February 2008, in Philadelphia. Talk focused on new drug regulatory issues, especially those arising under the 2007 Food and Drug Administration Amendments Act (FDAAA).
Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? Are you trying to figure out how to navigate the regulatory pathway for marketing your device? Prior to 1997, with the introduction of the FDA’s Modernization Act (FDAMA), if you answered yes to both questions, your device would automatically be considered a “new device” and be classified as a Class III device regardless of risk...
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.
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
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.
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
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.
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.
Matthew Professional CV experienced Government LiaisonMattGardner52
As an experienced Government Liaison, I have demonstrated expertise in Corporate Governance. My skill set includes senior-level management in Contract Management, Legal Support, and Diplomatic Relations. I have also gained proficiency as a Corporate Liaison, utilizing my strong background in accounting, finance, and legal, with a Bachelor's degree (B.A.) from California State University. My Administrative Skills further strengthen my ability to contribute to the growth and success of any organization.
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.
Guide on the use of Artificial Intelligence-based tools by lawyers and law fi...Massimo Talia
This guide aims to provide information on how lawyers will be able to use the opportunities provided by AI tools and how such tools could help the business processes of small firms. Its objective is to provide lawyers with some background to understand what they can and cannot realistically expect from these products. This guide aims to give a reference point for small law practices in the EU
against which they can evaluate those classes of AI applications that are probably the most relevant for them.
Lifting the Corporate Veil. Power Point Presentationseri bangash
"Lifting the Corporate Veil" is a legal concept that refers to the judicial act of disregarding the separate legal personality of a corporation or limited liability company (LLC). Normally, a corporation is considered a legal entity separate from its shareholders or members, meaning that the personal assets of shareholders or members are protected from the liabilities of the corporation. However, there are certain situations where courts may decide to "pierce" or "lift" the corporate veil, holding shareholders or members personally liable for the debts or actions of the corporation.
Here are some common scenarios in which courts might lift the corporate veil:
Fraud or Illegality: If shareholders or members use the corporate structure to perpetrate fraud, evade legal obligations, or engage in illegal activities, courts may disregard the corporate entity and hold those individuals personally liable.
Undercapitalization: If a corporation is formed with insufficient capital to conduct its intended business and meet its foreseeable liabilities, and this lack of capitalization results in harm to creditors or other parties, courts may lift the corporate veil to hold shareholders or members liable.
Failure to Observe Corporate Formalities: Corporations and LLCs are required to observe certain formalities, such as holding regular meetings, maintaining separate financial records, and avoiding commingling of personal and corporate assets. If these formalities are not observed and the corporate structure is used as a mere façade, courts may disregard the corporate entity.
Alter Ego: If there is such a unity of interest and ownership between the corporation and its shareholders or members that the separate personalities of the corporation and the individuals no longer exist, courts may treat the corporation as the alter ego of its owners and hold them personally liable.
Group Enterprises: In some cases, where multiple corporations are closely related or form part of a single economic unit, courts may pierce the corporate veil to achieve equity, particularly if one corporation's actions harm creditors or other stakeholders and the corporate structure is being used to shield culpable parties from liability.
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
Defending Weapons Offence Charges: Role of Mississauga Criminal Defence LawyersHarpreetSaini48
Discover how Mississauga criminal defence lawyers defend clients facing weapon offence charges with expert legal guidance and courtroom representation.
To know more visit: https://www.saini-law.com/
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/.
How to Obtain Permanent Residency in the Netherlands
An Overview of The “De Novo” Process – Reclassifying Devices Automatically Placed Into Class III
1. An Overview of The “De Novo” Process
– Reclassifying Devices Automatically
Placed Into Class III
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
2. Disclaimers
• The views and opinions expressed in the following PowerPoint
slides are those of the individual presenter and should not be
attributed to Drug Information Association, Inc. (“DIA”), its
directors, officers, employees, volunteers, members, chapters,
councils, Communities (formerly known as SIACs) or
affiliates, or the law firm with which the presenter is employed,
or any of the law firm’s clients.
• These PowerPoint slides are the intellectual property of the
individual presenter and are protected under the copyright
laws of the United States of America and other countries.
Used by permission. All rights reserved. Drug Information
Association, Drug Information Association Inc., DIA and DIA
logo are registered trademarks. All other trademarks are the
property of their respective owners.
2
3. Disclaimers
• These slides support an oral briefing and should not
be relied upon, solely on their own, to support any
conclusion of law or fact.
• This presentation is for general educational purposes
and does not constitute legal advice.
3
4. Whence “De Novo”??
• Device Amendments of 1976 -- if not pre-
amendment or substantially equivalent (SE), a newly-
introduced device automatically placed in Class III
• Problems of Automatic Class III Status –
– PMA route mandated -- but many devices did not warrant
expense or time
– PMA for these devices may not reflect risk
4
5. Whence “De Novo”?
• Problems of Automatic Class III Status ….
– PMA route is procedurally unwieldy --
• FDA -- first must issue rule officially classifying product
• Then -- separate rule requiring submission of PMA
– PMAs are substantively daunting -- clinical studies
raise expense
– Automatic Class III Status May Indirectly Cause SE
Drift -- firms trying to plug a new peg into an old hole to
avoid PMA route
5
6. An “Answer” to Automatic Class III
Status – FDAMA?
• Devices Center -- began to address issue in “re-
engineering” -- which re-focused the agency on using
risk as linchpin of regulatory decisions
• Congressional Solution -- § 207 of the 1997 Food &
Drug Administration Modernization Act (FDAMA) --
“Evaluation of Automatic Class III Designation”
6
7. Eligible Devices
• Legislative History -- “instructs the agency to limit
consideration to lower risk devices” found to be NSE.
[source: FDA 2/98 Guidance on 513(f)(2)]
– statute – is silent on what devices can be reclassified under de novo
• October 3, 2011 – New FDA Draft Guidance (DG)
– “this process provides a route to market for medical devices
that are low to moderate risk ...” -- that are automatically placed
in Class III (see DG at 3)
BUT CONTRAST --
– criteria to be applied – those under 513(a)(1) – thus, theoretically,
FDA should decide anew – “from an independent, risk-based
standpoint” -- if the device can be effectively regulated by Class II
or Class I controls (see DG at 4, Fn. 1)
7
8. Risk Criteria – What Applies for
a De Novo Petition?
• March 2012 -- Final Guidance on Factors to Consider in Benefit-
Risk Determinations in Medical Device Premarket Approvals and
De Novo Classifications
– http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Gu
idanceDocuments/UCM296379.pdf
8
9. How A Device Becomes Eligible
for de novo Consideration
• To Be Eligible --
– 510(k) – old rule -- must have been submitted –and denied as NSE --
before could file de novo petition
– FDASIA – July 2012 -- eliminated need to submit a 510(k) first and
have it declared non-substantially equivalent (NSE)
• can directly request
• can include draft of special controls that would apply
• but, still can go via 510(k) – NSE – petition route
– FDA has 120 days to decide
– FDA can decline if:
• concludes device belongs in Class III;
• that appropriate special controls are not possible; or
• identifies an appropriate predicate
9
10. The DG -- Additional Eligibility Criteria
• “New device should be low to moderate risk and
likely to meet the statutory standards for
classification into class I or class II under section
513(a)(1) … e.g., general and/or special controls
would provide reasonable assurance of safety and
effectiveness of the device; and …”
• You should sufficiently understand and be able to
explain all of the risks of the new device such that all
risks can be effectively mitigated through the
application of general and/or special controls.”
– DG at 5.
10
11. DG: Two Approaches to De Novo
• PDS – “Pre” de novo Submission – newly created by
DG – not clear how FDA will deal with this in wake of
FDASIA.
– FDA – now says, in a new note at the start of 2011 DG, that you
should confer with FDA before filing a de novo petition
– would still appear to be a possible approach, but FDA does not
seem to have commented on the PDS post-FDASIA
• Traditional de novo petition – still technically available
after FDASIA
11
12. The PDS
• Aim – early interaction with agency for a device for
which you feel there is no predicate and it is low or
moderate risk. Let’s FDA --
– see if device is suitable for de novo; and
– advise you on documentation needed in subsequent 510(k) and
de novo petition
– view on likely classification (II v. I)
– feedback on evidence, including performance or clinical data,
that may be needed to support the de novo petition
• Aim – make de novo process more predictable and
transparent
12
13. The PDS …
• Format and Content (DG – Attachment 3)
• Timing – may be early, but should know intended use and key
aspects of device design
• Should contain “sufficient information to enable us to
provide guidance on the test methods and protocols to be
used for the collection of performance data.”
– FDA may ask for clarification or more info to address protocol
deficiencies or other types of data FDA wants
• will do so within 60 days of initial PDS submission
• Can request a meeting to discuss the PDS – no earlier than
30 days after PDS submission
13
14. Format & Content of PDS
• Administrative Info
• Regulatory History
• Device Information &
Summary
• Classification
Recommendation
• Supporting Protocols
& Data
• Summary of Benefits
• Summary of Known &
Potential Risks to
Health
• Risk and Mitigation
Information
• Device Labeling
• Classification
Summary
Note – actual de novo petition is same
format, plus add section on how changed
since PDS (see Slide 20)
14
15. FDA Review – The PDS
• Preliminary review – to see if PDS contains adequate info
to allow FDA to review for de novo suitability
– more info requests – within 60 days of PDS receipt
• fail to reply within 180 days – FDA will regard PDS as withdrawn
• Suitability Review – once FDA deems you have sent in
adequate info.
• Threshold questions FDA will ask:
– Is there a likely predicate device for the device?
– Is device a type that FDA has classified into Class III on risk?
– Is device a type that has been approved under a PMA?
If yes to any of these, FDA will send a letter immediately saying (i) you
are not eligible for de novo and (ii) why
15
16. FDA Review – The PDS …
• If survive threshold questions, will continue PDS
review to see if general and/or special controls are
likely to be able to provide reasonable assurance of
safety and effectiveness
– if agree with de novo, then will send you a Suitability Letter
– if do not agree de novo is possible, will say why not
16
17. The PDS – FDA Response
• “Suitability Letter”
– 60 days after receipt of all information needed to complete the
review (see Slides 15 & 16 for PDS review process)
– Will specify:
• whether the device appears suitable for de novo
– if not, why not
• the likely class
• likely special controls – if any
• necessary performance data [note – the data you gather may end up
raising issues that will take you out of de novo process and keep you
in Class III]
17
18. Impact of a Positive PDS Suitability Letter
• Next step – concurrently submit both 510(k) and de
novo petition containing the info and data detailed in
the suitability letter
– Can x-reference between the 510(k) and the de novo petition
– Post-FDASIA – should not need to submit the 510(k); but
FDASIA also does not bar you from pursuing the “old”
approach to a de novo – i.e., 510(k) – NSE - Petition
18
19. The Post-PDS Concurrent
510(k)/de novo Petition
• Screening review – within 20 days of receiving
concurrent submission to see if both are adequate
– if not, review clock reset to 60 days once you submit rest
• if don’t submit rest in 180 days, deemed withdrawn
• Substantive review
– does a likely predicate device now exist?
• If so, petition will not be filed and 510(k) will be reviewed per
Substantial Equivalence (SE) standard
• If not, will issue NSE within 60 days of the submission and then
file the de novo petition and review it (see Slide 23 for petition
review process)
19
20. The “Traditional” de novo Petition
• Request for Evaluation of Automatic Class III
Designation
– Format & Content
• See Attachment 3 of DG for more detail
• Same as for PDS (see Slide 14) – but also describe all changes since
the PDS submission
– Describe the device
– Recommendation (if any) as to classification – supported in detail
– Reasons for Class recommended
– Identify risks and benefits of device – “all information and
evidence supporting the safety and effectiveness”
– The controls (general and/or special) to apply to the device
20
21. The “Traditional” de novo Petition …
• The Request ...
– If recommending Class I, include info whether device
should be exempt from:
• 510(k)
• Design Controls
– If recommending Class II, include info on the special
controls to govern
– Any available data on human experience
21
22. The “Traditional” de novo Petition …
• Due within 30 days of the date-stamp on the NSE
letter
– if miss that deadline, you can either submit a new 510(k) –
leading to a new NSE (and a new user fee) or pursue the PDS
route
• Addresses for filing – in DG at p. 8
22
23. FDA Review –
“Traditional” de novo Petition ...
• FDA Review of Request
– initial review – for content sufficiency
– had 60 days to review and reply; post-FDASIA, FDA
may claim it is 120 days
– may go to an Advisory Panel (in 60-day period)
– may request additional info -- if you don’t reply in 30 days,
“FDA will maintain the device in Class III” (see 2/98
Guidance, p. 4)
– will also consider info in the original 510(k)
– Final action -- by written order (may be in form of letter)
classifying the device
23
24. How the “Old” (not de novo)
Reclassification Petition Differs
• Is a public process – goes to FDA Dockets – in
contrast, the de novo “petition” has been to the
510(k) file and was not initially public
– but, will that change after FDASIA? Not clear, because
the technical language is not “petition,” but “request”;
not clear will go through public dockets
• “Old” petition -- see 21 CFR 860.134
• FDA must publish proposed order on
reclassification in Federal Register for public
comment
24
25. De Novo Classifications -- Examples
• Diagnostic Assays
– Antigen Invasive Fungal Pathogens
– Sirolimus Assay
– Test Factor V Leiden Mutaions, Genomic Dna Pcr Kit
– Ninhydrin and L- Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Assay
– Immunomagnetic, Circulating Cancer Cell Emuneration System
– Elisa Antibody, West Nile Virus
– Nitric Acid Breath Test
25
26. De Novo Classifications – Examples …
• Heimlich Maneuver Assist Device (Sept. 30, 1999):
Class II
– Cardiovascular
• Intended Use: to remove a foreign body airway obstruction
through generation of expulsion pressure
• Risks: incorrect use resulting in damage to internal organs; faulty
design generating too much pressure resulting in patient injury
• Special Controls: labeling with instructions for reporting
complications; adequate instructions for lay users; design controls
26
27. De Novo Classifications – Examples …
• Breast Lesion Documentation System (Jan. 31, 2003):
Class II
– Obstetrics Gynecology
– Intended Use: producing surface map of the breast as an aid to
document palpable breast lesions during clinical breast exam
– Risks: failure to produce appropriate map; misinterpretation;
improper use; skin irritation or toxicity; electric shock;
electromagnetic interference; tissue trauma
– Special Controls: labeling; materials safety information;
performance characteristics; bench testing; software information
27
28. De Novo Classifications – Examples …
• Infrared Hematoma Detector (Dec. 20, 2011)
– Ophthalmic
– Intended Use: detection of traumatic supratentorial hematomas
of greater than 3.5 ml in volume that are less than 2.5 cm from
brain surface … to assess patients for need for CT scans but
should not serve as a substitute for CT scans
– Risks: excessive laser power, interference with other devices,
unit malfunction, software malfunction, operator errors, false
positives or negatives, adverse tissue reaction, battery failure
– Special Controls: Rx use, ES and EMC, Performance testing,
software requirements, biocompatibility, labeling, training
– Guidance document – not clear will be issued
28
29. Examples of Special Controls
Imposed Via De Novo
* Many detailed device descriptions appear in the Guidance
Documents for inclusion in the 510(k), but are not listed specifically as
a special control.
* Clinicals -- many instances where the guidance created as the
“Special Control” says clinicals may be required if other data is
insufficient to show safety or effectiveness of the device, citing “Least
Burdensome” principle applicable to the device process.
* Animal testing -- was possibly required depending on other factors.
* Devices with software often required verification and validation as a
special control.
29
30. Questions Not Yet Answered
(or clearly):
• Must the device be “low risk” – or is “lower” risk
enough?
• Is the agency applying consistent with law and
legislation?
• Do you want to recommend the class for your device
(you don’t have to)?
– If you do and recommend Class II, must include special controls
recommendation
• Is this the route for your device -- pros and cons?
• Is this route being used too little...too much?
• Ever see a Class I reclassification (has not yet
happened under formal de novo process)?
30
31. For more information ...
• 21 U.S.C. §360c(f)(2) – Section 513(f)(2) of the Federal
Food, Drug, and Cosmetic Act
– See next slide
• 1998 FDA Guidance Document:
– http://www.fda.gov/downloads/MedicalDevices/DeviceReg
ulationandGuidance/GuidanceDocuments/ucm080197.pdf
• October 2011 Draft Guidance –
– http://www.fda.gov/downloads/MedicalDevices/DeviceReg
ulationandGuidance/GuidanceDocuments/UCM273903.pdf
• Matrix of De Novo Petitions Approved – 1998 to 2011 –
with Special Controls Detailed by Type
– (available from the speaker)
31
32. 32
Section 513(f)(2) of Federal Food, Drug, and Cosmetic Act
(as amended by the Food and Drug Administration
Safety & Innovation Act of 2012; PL 112-144)
(2)(A)(i) Any person who submits a report under section 360(k) of this title for a type of device that has not
been previously classified under this chapter, and that is classified into class III under paragraph (1), may
request, within 30 days after receiving written notice of such a classification, the Secretary to classify the
device.
(ii) In lieu of submitting a report under section 510(k) and submitting a request for classification under
clause (i) for a device, if a person determines there is no legally marketed device upon which to base a
determination of substantial equivalence (as defined in subsection (i)), a person may submit a request under
this clause for the Secretary to classify the device.
(iii) Upon receipt of a request under clause (i) or (ii), the Secretary shall classify the device subject to the
request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) within 120 days.
(iv) Notwithstanding clause (iii), the Secretary may decline to undertake a classification request submitted
under clause (ii) if the Secretary identifies a legally marketed device that could provide a reasonable basis for
review of substantial equivalence under paragraph (1), or when the Secretary determines that the device is
not of low-moderate risk or that general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
(v) The person submitting the request for classification under this subparagraph may recommend to the
Secretary a classification for the device and shall, if recommending classification in class II, include in the
request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are
necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness
and a description of how the special controls provide such assurance. Any such request shall described the
device and provide detailed information and reasons for the recommended classification.
(B)(i) The Secretary shall by written order classify the device involved. Such classification shall be the initial
classification of the device for purposes of paragraph (1) and any device classified under this paragraph shall
be a predicate device for determining substantial equivalence under paragraph (1).
(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the
meaning of section 351(f)(1)(B) of this title until approved under section 360e of this title or exempted from
such approval under section 360j(g) of this title.
(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary
shall publish a notice in the Federal Register announcing such classification.
(3)(A) The Secretary may initiate the reclassification of a device classified into class III under paragraph (1)
of this subsection or the manufacturer or importer of a device classified under paragraph (1) may petition
the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the
device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the
petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the
petition.
33. Questions?
• Call, e-mail or fax:
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
San Diego, California
direct: 619-744-2215
fax: 619-923-6248
maswit@duanemorris.com
• Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
33
34. About Your Speaker
Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law firm,
Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges faced by
highly-regulated pharmaceutical and medical device companies. 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. Mr. Swit has been addressing vital FDA legal and regulatory issues
since 1984, both in private practice with McKenna & Cuneo 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.
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