`VASCULAR SOLUTIONS LLC;
`TELEFLEX INNOVATIONS S.á R.L.,
`ARROW INTERNATIONAL, INC.,
`AND TELEFLEX LLC,
`
`
`Plaintiffs/
`Counterclaim Defendants,
`
`Court File No. 0:19-cv-1760 (PJS/TNL)
`
`DECLARATION OF HEATHER S.
`ROSECRANS
`
`CASE 0:19-cv-01760-PJS-TNL Document 110 Filed 11/15/19 Page 1 of 30
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`
`
`v.
`
`
`MEDTRONIC, INC. AND
`MEDTRONIC VASCULAR, INC.,
`
`
`Defendants/
`Counterclaim Plaintiffs.
`
`
`
`I, Heather S. Rosecrans, declare as follows:
`
`1.
`
`I have been retained by Defendants Medtronic, Inc. and Medtronic
`
`Vascular, Inc. (collectively, “Medtronic”) to provide my expert opinions in this matter. I
`
`make this declaration in opposition to the motion for a preliminary injunction filed by
`
`Plaintiffs Vascular Solutions LLC, Teleflex Innovations S.a.r.l, Arrow International, Inc.
`
`and Teleflex LLC (collectively, “Teleflex”). If called to testify, I could and would testify
`
`to the following facts and opinions.
`
`I.
`
`Background and Qualifications
`
`2. My educational background and professional history are summarized in the
`
`below paragraphs. My curriculum vitae is attached as Appendix A to this declaration.
`
`A.
`
`Education
`
`
`
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`3.
`
`In 1976, I was awarded a Bachelor’s Degree from Pfeiffer College where I
`
`majored in Biology.
`
`B.
`
`4.
`
`FDA Career
`
`Shortly after graduation, I began a 33-year career at FDA – the majority of
`
`which was spent working in what is now known as the Center for Devices and
`
`Radiological Health (“CDRH” or “the Center”). CDRH is responsible for regulating
`
`firms that manufacture, repackage, re-label, and/or import medical devices for
`
`commercial distribution in the United States.
`
`5.
`
`From 1978 to 1980, I held the position of Biologist in the Division of
`
`Clinical Laboratory Devices in the premarket review office at the Bureau of Medical
`
`Devices (now CDRH). My principal responsibilities included reviewing and tracking of
`
`premarket notification submissions (“510(k)s”) and Premarket Approval Applications
`
`(“PMAs”). Additionally, I was responsible for researching, interpreting, and drafting
`
`proposed and final microbiology devices classification regulations.1
`
`6.
`
`In 1980, I was assigned to the PMA Section in the premarket review office
`
`where I served as a Consumer Safety Officer. The PMA Section (later renamed “PMA
`
`Staff” and now called Division of Regulatory Programs 1 (Submission Support))
`
`oversees and coordinates the administrative and regulatory review of PMAs, product
`
`development protocols (“PDPs”), Humanitarian Device Exemptions (“HDE”) and
`
`associated submissions such as Environmental Assessments, Color Additive Petitions,
`
`
`1 See 21 C.F.R. Part 866 (final regulations).
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`Device Master Files, patent term extension petitions, and postapproval reports under
`
`Section 515 of the Federal Food, Drug, and Cosmetic Act (“FDCA” or “the Act”).2
`
`7.
`
`The CDRH PMA Section was in the newly organized Program
`
`Management Staff (“PMS”) and later called the Program Operations Staff (“POS”) in the
`
`Office of Device Evaluation (“ODE”) at CDRH. I held the position of Consumer Safety
`
`Officer in the PMA Section from 1980 until 1987. In this role, I was responsible for
`
`overseeing the review of PMAs and PDPs to ensure that the applications were reviewed
`
`in accordance with the statutory criteria and established regulations, procedures, policies,
`
`and time frames as well as participating in the development of related regulations,
`
`procedures, policies, and time frames. During this time, I was also responsible for
`
`developing appropriate educational materials and other guidance regarding PMA-related
`
`activities for use by CDRH, including the review staff, other FDA medical product
`
`Centers, and other stakeholders. I also provided training on PMAs and PDPs for the
`
`agency as well as for external stakeholders.
`
`8.
`
`In 1987, I joined the 510(k) Section of POS in ODE. The 510(k) Section
`
`(now known as the “510(k) Staff”) is responsible for overseeing and coordinating the
`
`regulatory and administrative review of 510(k) submissions in CDRH, assisting other
`
`Centers at FDA with 510(k)s, as well as providing information on the 510(k) program to
`
`other regulatory agencies and stakeholders.
`
`2 FDCA § 515, 21 U.S.C. § 360e.
`
`
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`9.
`
`From 1987 until 1992, I served as a Consumer Safety Officer in the 510(k)
`
`Section, where I provided regulatory, administrative, and policy oversight of CDRH’s
`
`review of 510(k)s. While serving in the 510(k) Section, I also assisted in writing the
`
`interim and final rules titled, “Medical Devices; Substantial Equivalence; 510(k)
`
`Summaries and 510(k) Statements, Class III Summary and Certification; Confidentiality
`
`of Information.”3 Additionally, I established the process for the rescission of 510(k)
`
`substantial equivalence decisions and worked on a proposed rule for the process.
`
`10.
`
`From 1992 to 2010, I held several changing titles that all involved the same
`
`job responsibilities and level of seniority. These titles included: (1) Acting Section Chief
`
`of the 510(k) Section; (2) Supervisory Consumer Safety Officer of the 510(k) Staff; and
`
`(3) Director of the 510(k) Staff. In this role, I was the primary contact on issues related
`
`to the implementation of the 510(k) requirements under the Safe Medical Devices Act of
`
`1990 (“SMDA”)4, 510(k) Summaries, 510(k) Statements, and Class III Certifications and
`
`Summaries to ensure the uniform interpretation of the law.5 I supervised the
`
`programmatic review of 510(k) submissions and 513(g) requests, device classification
`
`processes, petitions for reclassification, petitions for Class II exemption from 510(k), and
`
`other regulatory requirements. Additionally, I was responsible for drafting regulations
`
`regarding the above areas. I also trained CDRH and FDA’s Center for Biologics
`
`
`3 See 59 Fed. Reg. 64,295 (Dec. 14, 1994) (final rule); 57 Fed. Reg. 18,062 (Apr. 28, 1992) (interim rule).
`
`4 See Pub. L. No. 101-629 (1990).
`
`5 Although the law was passed in 1990, this requirement was not implemented until 1992.
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`Evaluation and Research (“CBER”) staff on statutory and regulatory requirements as well
`
`as procedures and policies—including any new regulations, policies, or procedures. I
`
`coordinated the regulatory review process of 510(k) submissions, including device
`
`determinations, between the CDRH premarket review staff and the CDRH Office of
`
`Compliance staff. I also managed any necessary coordination with the Office of
`
`Combination Products (“OCP”) (prior to 2002 when OCP was established, FDA’s
`
`Ombudsman handled combination products), the Center for Drug Evaluation and
`
`Research (“CDER”), and CBER for these programs.
`
`11.
`
`In 2009, I served as the CDRH lead in responding to the Government
`
`Accountability Office (“GAO”) study of the 510(k) program. Also in 2009, I served as a
`
`point of contact when FDA commissioned the Institute of Medicine (“IOM”) to
`
`undertake an assessment of the 510(k) program to determine what, if any, changes should
`
`be made to the program.
`
`12. During the IOM’s 18-month review of the 510(k) program, I provided
`
`training to the IOM review committee to educate members on the 510(k) program at their
`
`first public meeting in March 2010. My presentation to the IOM committee was titled,
`
`“Understanding the Premarket Notification (510(k)) Process: History from 1976 to
`
`2010.” As a member of the CDRH 510(k) Working Group, I also participated in the
`
`internal evaluation of the 510(k) program and subsequent “Plan of Action for
`
`Implementation of 510(k) and Science Recommendations,” which was published in draft
`
`in August 2010.
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`
`13. Additionally, while Director of the 510(k) Staff, I was responsible for
`
`identifying and resolving precedent-setting issues arising from reviews. I also provided
`
`expert consultation for the CDRH premarket review staff for the administrative and
`
`regulatory review of 510(k) submissions, including unique substantially equivalent
`
`decisions, 510(k) rescissions, not actively regulated device decisions, and classification
`
`and reclassification for a device type, as well as 513(g) requests.
`
`C.
`
`Professional Publications and Presentations
`
`14. During my time at FDA, I co-authored numerous guidance documents
`
`intended to provide FDA’s current thinking to FDA staff and all stakeholders on issues
`
`relating to 510(k) submissions. Those guidance documents include (but are not limited
`
`to):
`
`•
`
`•
`
`•
`
`•
`
`•
`
`“Guidance for Industry: Deciding When to Submit a 510(k) for a Change to
`
`an Existing Device (K-97)” (1997);
`
`“Guidance for Industry: Procedures for Class II Device Exemptions from
`
`Premarket Notification” (1998);
`
`“Guidance for Industry: Frequently Asked Questions on the New 510(k)
`
`Paradigm” (1998);
`
`“Guidance for Industry: Use of Standards in Substantial Equivalence
`
`Determinations” (2000);
`
`“Guidance for Industry: Determination of Intended Use for 510(k) Devices”
`
`(2002);
`
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`•
`
`•
`
`“Guidance for Industry: Format for Traditional and Abbreviated 510(k)s”
`
`(2005); and
`
`“Guidance for Industry: User Fees and Refunds for Premarket Notification
`
`Submissions (510(k)s)” (2004).
`
`15.
`
`I also coauthored “Draft Rule: Medical Devices; Rescission of
`
`Substantially Equivalent Decisions and Rescission Appeal Procedures” (2001).
`
`16. As mentioned previously, while at CDRH I was responsible for educating
`
`FDA staff on regulations and policies related to 510(k) reviews. I served as an “FDA
`
`Instructor” for multiple training sessions, which educated staff from CDRH, CDER,
`
`CBER, and the FDA field force on various subjects related to premarket regulation. The
`
`following is a sample of FDA training sessions where I served as an FDA Instructor
`
`during my tenure at FDA:
`
`“510(k), Reclassification & 513(g) – New Reviewer Training” (1990 –
`
`2006);
`
`“CBER/CDRH Reviewer Best Practices Workshop” (2002 - 2005);
`
`“510(k) Training for CBER and CDER with the Office of Combination
`
`Products” (2006);
`
`“FDA Office of In Vitro Diagnostic Devices Workshop: Practical
`
`Considerations in Preparing 510(k)s” (2004); and
`
`“Food and Drug Law Institute – CDRH In-House Training” (2004).
`
`•
`
`•
`
`•
`
`•
`
`•
`
`
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`17.
`
`I have also represented and spoken on behalf of FDA in multiple forums,
`
`including national conferences, FDA advisory committee meetings, and international
`
`symposiums. In this role, I provided training on topics including:
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`the Food and Drug Administration Modernization Act (“FDAMA”);
`
`Priority Premarket Implementation – 510(k) Intended Use;
`
`Reviewer Best Practices;
`
`510(k) Medical Device User Fee Modernization Act (“MDUFMA”)
`
`Premarket Training;
`
`In Vitro Diagnostic Devices;
`
`Practical Considerations in Preparing 510(k)s;
`
`CDRH Premarket Regulation of Combination Products;
`
`510(k) Reclassification;
`
`Medical Device Classification; and
`
`513(g) Requests.
`
`18.
`
`The following is a sample of events at which I provided guidance to
`
`stakeholders regarding the FDA 510(k) program during my tenure at FDA:
`
`•
`
`•
`
`Regulatory Affairs Professional Society (“RAPS”) International
`
`Symposium (2003);
`
`Advanced Medical Technology Association’s (“AdvaMed”) 13th Annual
`
`Device Submissions Workshop (2003);
`
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`•
`
`Annual FDA – Orange County Regulatory Affairs Education Conference
`
`(“OCRA”) (2004);
`
`• Medical Device Manufacturers Association (“MDMA”) 510(k) Workshop:
`
`What Every Medical Technology Company Should Know About the 510(k)
`
`Process (2004);
`
`AdvaMed Workshop: How to Plan for Premarket Meetings with CDRH
`
`(2005);
`
`RAPS Workshop: Today’s 510(k) Update (2005);
`
`Association of Clinical Research Professional’s Premarket Notification
`
`Conference (2008); and
`
`American Medical Association’s Advisory Committee regarding “Process
`
`•
`
`•
`
`•
`
`•
`
`for FDA Approval” (2008).
`
`D.
`
`Present Positions
`
`19. Currently, I serve as Executive Vice President of Medical Devices and
`
`Combination Products at Greenleaf Health, Inc. (“Greenleaf”). In this role, I am
`
`responsible for providing strategic regulatory consulting services for Greenleaf clients. I
`
`advise on issues related to the review of 510(k) submissions, CDRH regulatory policies,
`
`and FDA’s regulation of combination products.
`
`20. Additionally, I serve as Vice President of Regulatory Affairs at the Medical
`
`Device Manufacturers Association (“MDMA”). In this role, I offer policy advice to
`
`MDMA and its members regarding FDA device regulation.
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`
`E.
`
`21.
`
`Recent Speaking Engagements
`
`I continue to speak at industry and other stakeholder events where I provide
`
`insight and guidance regarding FDA’s 510(k) program, including (but not limited to) the
`
`following events:
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`Regulatory Affairs Professional Society (RAPS) San Francisco: “510(k)
`
`Requirements and Guidance” (2010);
`
`MedCon 2011: “A Historical Perspective of the 510(k) Program” (2011);
`
`RAPS Webcast: “The 510(k) Program—Update One Year After FDA
`
`Internal Study Report” (2012);
`
`Annual Medical Devices Summit East: “The 510(k) Program One Year
`
`Later” (2012);
`
`Drug Information Association (DIA) Conference: “Update on the 510(k)
`
`Program” (2012);
`
`22nd Annual Society of Clinical Research Associates (SOCRA) Conference:
`
`“The 510(k) Process” (2013);
`
`RAPS San Francisco: “510(k) Requirements and Guidance” (2013);
`
`23rd Annual SOCRA Conference: “The 510(k) Process” (2014);
`
`American Bar Association (ABA) Webinar on FDA Medical Device Law
`
`Fundamentals: “Principles of Premarket Classification” (2014);
`
`Medical Device Manufacturers Association (MDMA) FDA Forum:
`
`“Navigating Today’s 510(k) Program” (2015);
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`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`University of Miami Concept to Commercialization (C2C) Series:
`
`“Navigating FDA’s Premarket Pathway for Medical Devices” (2015);
`
`RAPS Workshop: “Peeling the 510(k) Onion from Fundamentals to Latest
`
`Topics” (2015);
`
`RAPS Workshop: “Peeling the 510(k) Onion from Fundamentals to Latest
`
`Trends” (2016);
`
`SOCRA Conference: “A Look at Today’s 510(k)” (2016);
`
`MedCon 2017: “510(k) Modifications: To Submit or Not Submit . . . That
`
`Is the Question!” (2017)
`
`Florida Medical Manufacturers Consortium, Inc.: “510(k) Updates: When
`
`and How to Work with FDA on Device Modifications” (2017);
`
`OCRA Conference: “Medical Devices and FDA: What, When, and How”
`
`(2017);
`
`RAPS Conference: “510(k) Regulatory Framework” (2017);
`
`RAPS European Union (EU) Conference: “Picking the Right Predicate”
`
`(2017);
`
`RAPS (EU) Conference: “When Things Go Wrong” (2018);
`
`MedCon 2018: “How Best to Interact with CDRH Premarket” (2018); and
`
`Food and Drug Law Institute Annual Meeting: “FDA CDRH Director
`
`Breakout Session” (2019).
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`•
`
`RAPS (EU) Workshop: The Basics of 510(k) and Working with FDA
`
`(2019).
`
`See also Appendix A, “Curriculum Vitae of Heather Rosecrans”; Appendix B, “Expert
`
`Witness Information for Heather Rosecrans.”
`
`II.
`
`Analysis and Opinions
`
`
`
`A.
`
`22.
`
`FDA Regulation of Medical Devices
`
`FDA is a scientific, regulatory, and public health agency. FDA’s statutory
`
`authority is derived from the FDCA. Its jurisdiction encompasses most food products
`
`(other than meat and poultry), including dietary supplements; human and animal drugs;
`
`therapeutic agents of biological origin; medical devices; radiation-emitting products for
`
`consumer, medical, and occupational use; cosmetics; animal feed; and, most recently,
`
`tobacco products.
`
`23.
`
`FDA prides itself on being a “science-based, science-led” regulatory
`
`agency. The agency has a strong regulatory and scientific staff. These resources ensure
`
`that FDA decisions are based on up-to-date science and applicable statutory and
`
`regulatory provisions.
`
`24.
`
`FDA includes six product Centers: (1) CDRH; (2) Center for Food Safety
`
`and Applied Nutrition (“CFSAN”); (3) CDER; (4) CBER; (5) Center for Veterinary
`
`Medicine (“CVM”); and (6) Center for Tobacco Products (“CTP”). These Centers
`
`review premarket applications, develop scientific and regulatory policy, work with
`
`FDA’s Office of Regulatory Affairs (ORA) and ORA’s district offices to ensure industry
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`compliance with regulatory requirements, and proactively and reactively address issues
`
`of potential public health concern.
`
`25. CDRH is responsible for regulating firms that manufacture, repackage, re-
`
`label, and/or import medical devices sold in the United States. In addition, CDRH
`
`regulates radiation-emitting electronic products (medical and non-medical), such as
`
`lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.
`
`26.
`
`If a product meets the definition of “device” in the FDCA, it will be
`
`regulated by FDA as a medical device and be subject to premarket and postmarket
`
`regulatory controls. The statutory definition of a “device” is:
`
`[A]n instrument, apparatus, implement, machine, contrivance,
`
`implant, in vitro reagent, or other similar or related article,
`
`including a component part, or accessory, which is—
`
`(1) recognized in the official National Formulary, or the
`
`United States Pharmacopoeia, or any supplement to them,
`
`(2) intended for use in the diagnosis of disease or other
`
`conditions, or in the cure, mitigation, treatment, or prevention
`
`of disease, in man or other animals, or
`
`(3) intended to affect the structure or any function of the body
`
`of man or other animals, and
`
`which does not achieve its primary intended purposes through
`
`chemical action within or on the body of man or other
`
`animals and which is not dependent upon being metabolized
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`for the achievement of any of its primary intended purposes.
`
`The term “device” does not include software functions
`
`excluded pursuant to section 360j(o) of this title.6
`
`27. Medical devices are classified into one of three classes: Class I, II, or III.
`
`Regulatory control increases from Class I to Class III. The device classification defines
`
`the regulatory requirements for a generic type device. Most Class I devices are exempt
`
`from the 510(k) requirements of the Act; most Class II devices require 510(k) review and
`
`a determination by FDA of substantial equivalence prior to commercial distribution in the
`
`U.S.; and Class III devices require PMA review and approval prior to commercial
`
`distribution in the U.S.7
`
`28. Class I Devices. Class I devices are generally subject only to “general
`
`controls,” because the risks are well understood and general controls are sufficient to
`
`provide reasonable assurance of safety and effectiveness.8 General controls include:
`
`510(k), banning, misbranding, adulteration, compliance with the applicable portions of
`
`the Quality System Regulation (“QSR”) for manufacturing and recordkeeping,
`
`requirements for issuing notices about repair, replacing or refunding money for devices
`
`
`6 FDCA § 201(h), 21 U.S.C. § 321(h).
`
`7 The one exception is cranial electrotheraphy stimulators. CDRH is still considering whether to call for PMA
`applications for this device type. See FDA Website, 515 Project Status, available at https://www.fda.gov/about-
`fda/cdrh-transparency/515-project-status (accessed Nov. 5, 2019).
`
`8 See 21 C.F.R. § 860.3(c)(1).
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`presenting an unreasonable risk of substantial harm, facility registration and product
`
`listing, adverse event reporting, and labeling.9
`
`29.
`
`The Food and Drug Administration Modernization Act of 1997
`
`(“FDAMA”), under Section 510(l), exempted all Class I devices from FDA’s 510(k)
`
`requirements except those that are intended for a use that is of substantial importance in
`
`preventing the impairment of human health or that present a potentially unreasonable risk
`
`of injury or illness.10 FDA “reserved” those device types defined in the exception above
`
`as requiring 510(k) submission and a determination by FDA that the device is
`
`substantially equivalent prior to commercial distribution in the U.S. FDA also has
`
`regulations on limitations to exemption from the 510(k) requirements of the Act.
`
`30.
`
`Examples of Class I devices include elastic bandages, examination gloves,
`
`non-prescription sunglasses, microbiological specimen collection and transport devices,
`
`and certain hand-held surgical instruments.
`
`31. Class II Devices. Class II devices are devices for which general controls
`
`alone are insufficient to provide reasonable assurance of their safety and effectiveness,
`
`but special controls can be identified to address the risks—in addition to the general
`
`controls of the FDCA. Class II devices are subject to both general and special controls
`
`and require 510(k) review (unless specifically exempted from the 510(k) requirements of
`
`the Act subject to limitations on exemption) and a determination by FDA that there is
`
`
`9 All classes of devices are subject to general controls. General controls are the baseline requirements of the FDCA
`that apply to all medical devices—Class I, II, or III.
`
`10 FDCA § 510(l), 21 U.S.C. § 360(l).
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`reasonable assurance of safety and effectiveness that demonstrates the device is
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`substantially equivalent to a legally marketed predicate device prior to commercial
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`distribution in the U.S.
`
`32.
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`Special controls include performance standards, FDA guidance documents,
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`special labeling requirements, tracking of implantable devices, clinical data, and other
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`actions the agency deems necessary to provide reasonable assurance of safety and
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`effectiveness.11
`
`33.
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`Examples of Class II devices include powered wheelchairs, bone cement,
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`knee implants, glucose test systems, ventilators, dialysis systems, surgical drapes, and
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`percutaneous catheters.
`
`34. Class III Devices. In addition to general controls, Class III devices are
`
`those that must receive review and approval by FDA in a PMA to provide reasonable
`
`assurance of their safety and effectiveness prior to commercial distribution in the U.S.
`
`The risks for this type of device are not well understood, and therefore special controls
`
`cannot be identified for this type of device.
`
`35.
`
`Examples of Class III devices that require a PMA are mechanical heart
`
`valves, breast implants, drug-eluting stents, bone growth stimulators, most pacemakers,
`
`intraocular lenses, extended wear contact lenses, certain in vitro diagnostics, and new
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`devices that have been found not to be substantially equivalent to legally marketed
`
`11 See 21 C.F.R. § 860.3(c)(2).
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`devices for lack of a predicate device, a new intended use, or a new technology that raises
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`a different type of safety and effectiveness question.
`
`B.
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`510(k) Premarket Review and Clearance
`
`36. As addressed within the “Qualifications” section of this report, my
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`regulatory expertise is focused on the 510(k) program. While at FDA, I played a pivotal
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`role in the 510(k) program’s development and reform.
`
`37. More than 90 percent of medical devices fall within FDA’s 510(k)
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`authority.12 The 510(k) premarket notification process refers to Section 510(k) of the
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`FDCA and is used for devices that are to be reviewed by FDA for a determination of
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`substantial equivalence to a legally marketed Class I or Class II device, unless the device
`
`type has been exempted from the 510(k) requirements of the Act. A manufacturer is
`
`required to file a 510(k) and receive an FDA determination of substantial equivalence
`
`prior to initial marketing of a device; making a change or modification to a cleared device
`
`that could significantly affect the safety or effectiveness of the device; or making a major
`
`change or modification to the intended use of its previously cleared device.13
`
`38.
`
`The FDA review requirements for a 510(k) are to first determine that there
`
`is a predicate device,14 that the new device has the same intended use, same technology,
`
`
`12 See U.S. General Accounting Office, Report to the Chairman, Subcommittee on Health and the Environment,
`Committee on Energy and Commerce, House of Representatives, Medical Devices: FDA's 510(k) Operations Could
`Be Improved at 2 (Aug. 1988), available at http://archive.gao.gov/d16t6/136821.pdf (accessed Nov. 5, 2019).
`
`13 21 C.F.R. § 807.81.
`
`14 Any legally U.S. marketed device, which does not require a PMA, may be used as a predicate. This includes: a
`device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976
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`or a different technology that does not raise a new type of safety and effectiveness
`
`question as compared to the predicate, and lastly that performance data demonstrate that
`
`the new device is at least as safe and effective as the predicate.15
`
`39. A device that requires 510(k) review and clearance may not be marketed
`
`until the applicant receives an “order” from FDA, which states that the new device has
`
`been determined to be substantially equivalent (“SE”), that is at least as safe and effective
`
`as the legally marketed predicate device.
`
`40.
`
`Substantial Equivalence. For a new device to be determined to be
`
`“substantially equivalent” by FDA to one or more legally marketed predicate devices, it
`
`must have the same intended use as a predicate(s) and either the same technological
`
`characteristics as the predicate device or different technological characteristics, but the
`
`information submitted contains information that demonstrates that the device is as safe
`
`and effective as the predicate and does not raise different questions of safety and
`
`effectiveness than the predicate.16 Performance data is required to demonstrate that the
`
`new device is at least as safe and effective as the predicate (unless it is identical to the
`
`predicate, then a comparison of specifications is adequate).17 The majority of 510(k)s
`
`
`that does not require PMA (a preamendment device); a device that was on the U.S. market after May 28, 1976 as a
`Class III device (Premarket Approval); later downclassified to Class II or I; a 510(k) exempt device; or a device type
`that has been classified through the de novo petition process.
`
`15 See 21 C.F.R. § 807.81(a)(3).
`
`16 See FDCA § 513(i), 21 U.S.C. § 360c(i).
`
`17 See 21 C.F.R. § 807.92(b).
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`received by FDA for review have some differences in the indication for use and/or
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`technological characteristics when compared to the predicate.
`
`41. Any device legally marketed in the U.S. that does not require a PMA may
`
`be used as a predicate. Legally marketed predicates include: a device that has been
`
`cleared through the 510(k) process; a device that was legally marketed prior to May 28,
`
`1976 (a preamendment device) and for which FDA has not called for PMAs; a device
`
`that was originally on the U.S. market as a Class III device (PMA) and later
`
`downclassified to Class II or I; a device that has been classified through the de novo
`
`petition process into Class I or Class II; or a 510(k)-exempt device.
`
`42.
`
`The content of a 510(k) basically includes: the device name and class; an
`
`establishment registration number (if one has been received); an “Indication for Use
`
`Statement”; directions for use; photographs or engineering drawings, where applicable; a
`
`510(k) summary or 510(k) statement; proposed labeling; substantial equivalence
`
`comparison with the predicate; supporting performance data (bench, animal, and/or
`
`clinical); and any additional information regarding the device requested by the
`
`Commissioner that is necessary to make a finding as to whether or not the device is
`
`substantially equivalent to a predicate device.18
`
`43.
`
`In addition to the above-mentioned requirements, 510(k) submitters must
`
`include a statement that all data and information submitted are truthful and accurate and
`
`
`18 21 C.F.R. § 807.87; see also Guidance for Industry and FDA Staff: Refuse to Accept Policy for 510(k)s (Sept.
`2019), available at https://www.fda.gov/media/83888/download (accessed Nov. 5, 2019).
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`that no material fact has been omitted.19 The truthful and accurate statement carries
`
`significant legal implications, which may result in judicial action should FDA determine
`
`that false information was provided or material facts were omitted.
`
`44.
`
`Performance Data Requirements. It is a common misperception that
`
`510(k)s do not contain performance data. The manufacturer of a device that has the
`
`identical indications for use and the identical technological characteristics as a predicate
`
`device need only submit descriptive data, including side-by-side comparisons of the new
`
`device and the legally marketed device with which it is compared. This is a very unusual
`
`type of 510(k) for FDA to receive for review.
`
`45.
`
`If there are any differences in the indications for use between a new device
`
`and a predicate and/or there are any different technological characteristics, the
`
`submission will need to contain the descriptive characteristics as well as performance
`
`data, including bench, animal, and/or clinical data for FDA to review to determine if the
`
`new device can be found substantially equivalent to the predicate device or not.20
`
`46. Labeling Requirements. FDA regulations require a manufacturer to
`
`submit any “additional information regarding the device requested by [FDA] that is
`
`necessary for the [FDA] to make a finding as to whether or not the device is substantially
`
`19 Id. § 807.87(k).
`
`
`
`20 See Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial
`Equivalence in Premarket Notifications [510(k)] at 23 (July 28, 2014), available at
`https://www.fda.gov/media/82395/download (accessed No