February 2008 Webinar Presentation to the LARTA NIH-CAP Program; general overview of FDA regulation of medical devices.

1. Overview of FDA Regulation
of Devices & Diagnostics
Michael A. Swit, Esq.
Vice President
LARTA
NIH-CAP Program
Webinar
February 2008

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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
may not be relied upon solely on its own to
reach any conclusion of law or fact.

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Regulatory Overview
• Food and Drug Administration is the sole
federal agency regulating safety and effectiveness
for medical devices
• Medical devices first regulated by FDA in 1938
• 1976 -- Major reform of regulations occurred in
Device Amendments

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Statutory Overview
• Safe Medical Devices Act of 1990 (SMDA)
– Problems with the “76” amendments; left a lot of
leeway for industry to work around the more
stringent requirements of the amendments
– SMDA initiated more market entry “Gatekeeper”
functions, enforcement and compliance, safety and
post-marketing surveillance
– Resulted in Quality System Regulation (QSR)

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Statutory Overview
• Medical Device Amendment of 1992 --
“tweaking of the law”
• FDAMA -- Food and Drug Modernization Act
of 1997 -- key theme -- FDA’s mission includes
timely review and approval of beneficial new
products
• MDUFMA – 2002 -- User Fees and additional
tweaks (e.g., combination products)

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What is a Medical Device?
• Section 201(h) of the FDCA defines a device as:
… an instrument, apparatus implement, contrivance, implant, in vitro reagent,
or other similar or related article, including components, parts or accessories
which are;
(1) Recognized in the National Formulary, or US Pharmacopeia
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or
prevention of disease
(3) intended to affect the structure or any function of the body and which
does not achieve its primary intended purposes through chemical
action within or on the body and which is not dependent upon being
metabolized for the achievement of its primary intended purposes

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Device Classification
• Risk based
– Class I -- includes devices with the lowest risk,
subject to general controls – e.g., labeling, listing,
QSRs, etc.
– Class II -- includes devices for which general
controls are insufficient to assure safety and
effectiveness -- mandatory performance standards

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Device Classification …
• Class III -- devices with the greatest risk and
insufficient information exists to assure safety
and efficacy
– generally require a PMA submission
– “Post amendment” Class III devices considered
substantially equivalent to pre-amendment devices
may be marketed through the 510(k) process until
FDA specifies PMA requirement
– New technology – automatically into Class III,
regardless of risk

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Ways to Market a Medical Device
• Premarket Approval (PMA) – for Class III devices
– FDA has 180 days to review the PMA and make a
determination of safety and effectiveness
– Usually requires clinical studies
• “510(k)” or “Premarket Notification” – for most
Class II and some Class I devices
– notify FDA 90 days prior to introducing a device into the US
market
– Must show “substantial equivalence” to a “predicate” device
• General Controls – if PMA or 510k not required, go
to market

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Investigational Device
Exemption (“IDE”)
• Needed to conduct clinical studies of devices in
most instances (there are exceptions)
• Three basic types
– Feasibility Study -- evaluate safety
– Pilot Study -- effectiveness and optimization of
clinical protocol
– Pivotal Study -- expanded study with finished device
and intended population

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IDE …
• Institutional Review Board (IRB) must review
and approve IDE
• IRB must make determination of significant risk
vs non-significant risk device
• Significant risk device -- one that presents a
potential risk to the health, safety, or welfare of
a human study subject. Includes devices used in
supporting or sustaining human life or
substantial importance in preventing impairment

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IDE …
• Examples of significant risk devices:
▪ Implantable devices
▪ CPR devices
▪ Extended wear contact lenses
▪ Injectable collagen
▪ Intrauterine devices

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IDE …
• Examples of non-significant risk devices:
▪ Daily-wear contact lenses
▪ General hospital catheters
▪ MRIs within FDA specified parameters
▪ Limited classes of wound dressing
Listing of significant and non-significant risk devices is available in
“FDA Guidance for Institutional Review Boards and Clinical
Investigators”

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Premarket Approval Application
(“PMA”)
• Standard of Approval –
– “…valid scientific evidence …there is reasonable assurance
that the device is safe and effective…”
– “Valid scientific evidence is evidence from well-controlled
investigations …that there is reasonable assurance of the
safety and effectiveness of a device under its conditions of
use…”
• Two approaches to filing a PMA –
– Traditional PMA
• Full and complete filing in first instance
• Initially reviewed by FDA scientist and experts to determine whether
file is “administratively complete” and meets the requirements of 21
CFR Part 814, PMA is then officially filed

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PMA …
• Modular Approach
– Sponsor is responsible for PMA “shell” -- outline of
basic sections for PMA
– Mechanism for interaction of sponsor with agency
reviewers
– Breaks the PMA into well-delineated components,
stages or “modules”
– Module reports filed when testing and analysis of
particular module is complete

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PMA -- Changes
• Amendments: used to revise existing
information, prior to approval
• Supplement: changes that affect
safety or effectiveness of the existing
device such as intended use, labeling,
packaging, sterilization
–May require new clinical studies

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510(k)
• Device is substantially equivalent if in comparison to
predicate device, the new device has:
▪ same intended use as predicate
▪ same technological characteristics as predicate
▪ if new device has different technological characteristics:
▪ they do not raise new questions of safety and effectiveness; and
▪ sponsor demonstrates that new device is as safe and effective as
predicate

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510(k) & Substantial Equivalence
• Substantial equivalence (“SE”) does not mean
new device and predicate must be identical
• SE -- established relative to intended use, design,
energy used or delivered, materials, safety,
performance, effectiveness, labeling,
biocompatibility, standards and other applicable
characteristics
• Clinical studies -- about 10% of 510(k) need to
show SE

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510(k) …
• Who is required to submit --
▪ domestic manufactures introducing device to US
markets
▪ specification developers introducing device to US
markets
▪ repackers or relabelers who make a labeling change,
or whose operations significantly affect device
▪ foreign manufactures/exporters or US
representatives offoreign /exporters introducing a
device to US market

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Types of 510(k)
• Three types of 510(k) developed under “510(k)
Paradigm”
– Special 510(k)
• Limited to certain circumstances and must contain a
“Declaration of Conformity” with design control
requirements
• FDA intends to process special 510(k)s within 30 days of
DCO receipt

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Types of 510(k) …
• Abbreviated 510(k) - manufacturer may choose if one of the
following apply:
– Guidance document exist
– A special control has been established
– FDA has recognized a relevant consensus standard
• If relying on either a guidance document or special controls,
manufacturer must provide a summary that describes adherence
to such documents during development and testing of the
device.
• If relying on an FDA recognized standard, manufacturer must
include “Declaration of Conformity” to the recognized
standard
– About 400 standards to which submitter can declare conformity

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Types of 510(k) …
• Traditional 510(k) -- No specific 510(k) form but
there is an FDA suggested format
• Steps to preparing a Traditional 510(k)
– Find a predicate
– If applicable use Guidance Documents
– Prepare and format all contents
– Assemble 510(k)
• For more detailed information on preparing a
Traditional 510(k) --
http://www.fda.gov/cdrh/devadvice/3143.html

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Quality System Regulation
• Instituted because Good Manufacturing
Practices did not address “original design of
device”
• Needed pre-production design controls
• New authority given to FDA to require
manufacturers to have documented and
validated design controls for the production of
new devices

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User Fees
• First authorized in 2002 under the Medical
Device User Fee and Modernization Act
(MDUFMA)
• Reauthorized through FY 2012 by Food & Drug
Administration Amendments Act (“FDAAA”)
– PMA -- $185,000
– PMA-Supp: $27,750
– 510(k) -- $3,404

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Quality System Regulation
• Places focus on post-marketing as well as pre-
marketing activities
• Prior to QSR going into effect, 44% of quality
problems during a 6-year period attributed to
design related defects

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Quality System Inspection
Technique
• QSIT -- focuses on four major QS subsystems:
– Management Controls
– Design Controls
– Corrective and Preventive Actions (CAPA)
– Production and Process Controls
• For more information and guidance on Quality
System Regulation:
http://www.fda.gov/cdrh/comp/gmp.html

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Federal Device Hierarchy
President
HHS Secretary
FDA Commissioner
Center for Devices &
Radiological Health Director
Office of Regulatory Affairs
Office of Device Evaluation Local FDA District Office
Office of Compliance
Office of Surveillance
& Biometrics
Office of Compliance
Field Inspectors

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Resources
• Code of Federal Regulations (“CFR”) -- 21 Parts
800 to 1299 – Key provisions:
– 801 – Labeling
– 803 – Medical Device Reporting (“MDR”)
– 807 – Registration, Listing, and 510(k)
– 812 – IDE
– 814 – PMA
– 820 – QSR
– 822 – Postmarket Surveillance
– 860 – Classifications
• FDA Website -- http://www.fda.gov/cdrh/devadvice

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Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP INC.
336 North Coast Hwy. 101
Suite C
Encinitas, CA 92024
Phone 760.633.3343
Fax 760.454.2979
Cell 760.815.4762
michael.swit@weinberggroup.com
www.weinberggroup.com
Questions?

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About your speaker…
Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the
execution of a broad array of regulatory and other services to clients, both directly and through outside counsel. His
expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis
management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical
research efforts for drug, biologic, device, IVD, and other life sciences companies, as well as those in the food and
dietary supplement industries.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience
includes serving for three and a half years as corporate vice president, general counsel and secretary of Par
Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial
perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of
FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the
FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the
FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug
Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced
FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored
by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his
law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.

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