The 510(k) Process

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Disclaimers
• This presentation, and the materials included
herewith, are provided for general educational
purposes and should not be construed as legal
advice.
• The views expressed in this presentation are mine
and do not necessarily represent those of any of my
clients or any other third party.
• These slides support the oral briefing provided by
this presentation. As such, the reader should not
rely solely on these slides to support any conclusion
of law or fact.
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What We Will Cover
• Legal Framework for 510(k)’s
• Strategy Considerations – Claims & Functions
• Device Modifications
• Regulatory Mechanisms to Implement Changes
• The Review
• What To Do if FDA Says You’re NSE
• Key Lessons Learned
• Reform and Other Recent Trends at FDA
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Legal Framework for 510(k)’s
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Section 510(k) of the Act
• Must “notify” FDA 90 days before propose to begin
marketing a new device or certain modified devices
• In reality, a 510(k) is much more than a “notice,” and
marketing cannot begin until clearance
• Purpose -- allow FDA to determine:
– if device is truly novel and requires new proof of safety and efficacy; or
– whether device is similar enough (“substantially equivalent” or “SE”) to a
device already lawfully on the market (a “predicate”) to permit marketing
without as detailed a review as a Premarket Approval Application (PMA)
required of Class III device
• FDA -- considerable discretion to decide whether a product
requires a 510(k) or a PMA, or is available for de novo
reclassification5

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510(k) Notices -- Required For:
• Small number of Class I devices (specifically
called out in the regulations)
• 510(k) exempt devices -- if the new device exceeds
the limitations of the exemption
• Most Class II devices
• Pre-amendment Class III devices (marketed post-
1976) for which PMAs are not currently required;
very limited
– FDA effort ongoing to classify these products
Any of these can be a “predicate” device to support
another’s 510(k)6

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What is Substantial Equivalence?
• 1976 Congressional Record
“The term ‘substantially equivalent’ is not intended to be so
narrow as to refer only to devices that are identical to marketed
devices nor so broad as to refer to devices which are intended
to be used for the same purposes as marketed products. The
committee believes that the term should be construed narrowly
where necessary to assure the safety and effectiveness of a
device but not narrowly where differences between a new
device and a marketed device do not relate to safety and
effectiveness.”

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Criteria for SE -- 510(k) Memorandum #K86-3
• The new device has the same intended use; and,
• The new device has the same technological characteristics,
(i.e., same materials, design, energy source, etc.); or, if it
has new technological characteristics, those new
technological characteristics do not raise new questions of
safety or efficacy, and
• There are accepted scientific methods for evaluating
whether safety or effectiveness has been adversely affected
as a result of the use of new technological characteristics;
and
• There are data to demonstrate that the new technological
features have not diminished safety or effectiveness.
– http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm081383.htm
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Combination or “Multiple” Predicates
• Combinations of predicates can be used in limited
circumstances
– Established in 1986 guidance (#K86-3)
– May use multiple predicates to demonstrate similarity of new
device to prior technology
 Example: same dimensions as one predicate, same materials as
another
 More challenging: same indications as one predicate, same
technology as another (“split predicates”)
more …
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Combination or “Multiple” Predicates …
– If no predicate with both same indications and similar
technology, more supporting data may be needed
– Example: RF ablation device for fecal incontinence
 Potential predicates may include RF devices for shrinking other soft
tissues and biofeedback devices for incontinence
• Increasing resistance to combination predicate
arguments
– Agency effort underway to eliminate use of “split predicates”
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Searching For 510(k) Info
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510(k) Decision Making Process
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Strategy Considerations:
Choosing the Right Claim and
Introducing New Features

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General Criteria to be Deemed
Substantially Equivalent
• Intended Use
– Describes general purpose for which the device is used
– Must be exactly the same as predicate
• Indications for use
• Higher degree of specificity than intended use
• May describe a specific diagnostic or therapeutic purpose
• May include a description of the population, the environment
of use (prescription versus OTC)
• Indications need not be identical, but differences should not
alter the intended diagnostic or therapeutic effect,
considering the effect on safety and effectiveness14

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Comparison of Intended
Use/Indications
• Example: RF ablation for palliative treatment of
inoperable liver cancer
– Intended use: Soft tissue ablation
– Indications for use: Palliative treatment of inoperable liver cancer
• In drafting 510(k) substantial equivalence argument,
first step is to identify predicates and draft an
intended use statement that is common to new
device and predicate
more …15

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Comparison of Intended
Use/Indications …
• If there are differences in indications, must next
demonstrate why those differences do not alter
intended diagnostic or therapeutic effect,
considering impact on safety and effectiveness
• Off-label use of predicate cannot be used to support
an SE finding no matter how prevalent
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Choice of Intended Use/
Indications for Use
• Can have a big impact on relative difficulty/ease of
510(k) clearance
• Example: Tool versus treatment
• Generally best to “start small,” work incrementally
• In some cases, there is a “bright line” that divides
claims that can be cleared in a 510(k) from those
that require a PMA
• Example: PSA – when used for detection = PMA vs.
monitoring patients already diagnosed with cancer = 510(k)
 Time difference of years to clearance/approval
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Choice of Indications and Off-Label Use
• Clearing device for more general use first to permit
more straightforward pathway/less onerous data
requirements is generally desirable, BUT
• If extensive off-label use is expected, or if the off-label use is
really the only use, this can be problematic
 Potential for FDA enforcement action
 Products liability
 Cannot provide adequate directions/warnings for the off-label use without making
the product adulterated and/or misbranded
• May also be reimbursement issues if device indication does
not match its principal use
 Examples – Cardiac catheters used for ablation; biliary stents used in the
peripheral vasculature18

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Intended Use and Section 513(i)(1)(E)
• Section 513(i)(1)(E) of the Federal Food, Drug, and
Cosmetic Act generally limits the determination of
the intended use of a device that is the subject of a
510(k) to the proposed labeling in the submission
• Off-label uses may not be considered unless
– There is a “reasonable likelihood” that the device will be used
for an intended use other than that in the proposed labeling;
and
– That use could cause harm
more …19

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Intended Use and Section 513(i)(1)(E) …
• If FDA finds there is likely off-label use that could
cause harm, must notify applicant:
– Sponsor can modify the device design to address the off-label
use; or
– Sponsor can request a written determination from the FDA
Office Director;
– FDA can issue a SE letter with limitations specifying
appropriate limitation regarding the off-label use to be
included in the labeling for the device.
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Comparison of Technological Characteristics
• A device is SE to another device if it has the same
intended use and either:
– (i) the same technological characteristics or
– (ii) different technological characteristics but is as safe and
effective as the other device and does not raise different
questions of safety or effectiveness. FDCA § 513(I)(1)(A)g,
21 U.S.C. § 360c(I)(1)(a)
• New or different technological characteristics
include modifications in:
– Design;
– Materials;
– Energy source; or
– Principles of operation21

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Comparing Technological Characteristics…
• Making persuasive arguments:
– Remember that new/different technological features can
impact safety and effectiveness without being NSE
– Important not to avoid obvious differences - instead, explain
why the differences do not raise new types of safety or
effectiveness issues
– Example: RF ablation of soft tissue versus high intensity
focused ultrasound (HIFU)
 Difference in technology could, in theory, impact safety or effectiveness
 However, no new question of safety or effectiveness because heat is heat
 Question of whether temperature is properly controlled/adequate heating for
target ablation without extended area of thermal damage is common to both
devices
 Therefore, can be found SE
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Comparing Technological Characteristics…
• Making persuasive arguments:
– Differences that are susceptible to standard bench testing to
demonstrate they do not adversely impact safety or
effectiveness -- generally SE
– Differences that require clinical testing may also be SE but
more challenging
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How Much is Too Much?
• If new claim with no strong predicate, may not
want to change too many technological features
in first submission
• Consider phased approach in which new
indication is pursued first, followed by Special
510(k)s or other filings as appropriate for changes
in technological features, OR
• Clear all new technological features first, then
pursue new indication
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When is a Pre-Submission Meeting
Warranted?
• Uncertainty regarding data requirements
(preclinical or clinical)
• When a clinical study may be necessary
• When an expensive or lengthy preclinical test may
be necessary
• When there is no guidance/little precedent/no
industry standards
more …
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When is a Pre-Submission Meeting
Warranted …?
• When 510(k) pathway is unclear/de novo may be a
possibility
– Typically takes up to 60 days to schedule meeting
after background package is submitted
– However, up front time may save subsequent review
time
• Use of Pre-Submission process has increased (289
submissions received by ODE in 2003, 656 in 2009)
• Draft guidance – July 2012 – available at:
http://www.fdacounsel.com/files/July_13_2012_Draft_Guidance_on_Medical_Devices__Pre-
Submission_Meetings.pdf26

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Device Modifications

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Device Modifications –
21 C.F.R. 807.81(a)(3)
• A new 510(k) must be filed for a legally marketed
device if it is about to be significantly modified in
design, components, method of manufacture, or
intended use
• Significant modifications include:
– Changes that could significantly affect safety or effectiveness,
e.g., a significant change in design, material, chemical
composition, energy source, or manufacturing process
– Major changes in the “intended use” of the device
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Determining Whether a 510(k) Must Be
Submitted for a Device Modification
• Is the proposed modification “significant”?
• Does it effect a major change in the indications
for use?
• “Could” it significantly affect safety or
effectiveness?
• Company makes initial decision, but FDA can
disagree
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510(k) Modification Guidance -- 1997
• Manufacturers and FDA often had difficulty
interpreting what types of modifications were
“significant”; what types of changes to the intended
use were “major”; and when a change “could
significantly affect safety or effectiveness”
• The guidance clarifies the meaning of terms such as
“major” and “significant”
• The guidance provides separate analyses for the
following types of changes:
– Labeling changes
– Technology, engineering, and performance changes; and
– Materials changes (IVDs and non-IVDs)30

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510(k) Modification Guidance – 1997 …
• If conclusion is made that no new 510(k) is required,
document in memo to file showing the logic on
proper flow chart, together with appropriate
supporting data, is important
– Even if FDA disagrees with a decision not to file in an
inspection, a thorough memo to file may help to reduce risk of
enforcement
• Cumulative effect of multiple changes should be
considered
• 1997 Guidance -- still in effect
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Technology, Engineering, and
Performance Changes
• All changes in technology, engineering, and performance are
evaluated and validated according to the Quality Systems
Regulations (QSR) requirements to determine if a new
510(k) notice must be filed
• Examples of technology, engineering, and performance
changes that generally require a new 510(k) notice:
– Control mechanism (e.g., analog to digital control; pneumatic to electronic)
– Operating principle;
– Energy source; or
– Sterilization procedure in a manner that affects performance specifications
or reduces the sterility assurance level
more …32

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Technology, Engineering, and
Performance Changes …
• Other types of engineering changes, i.e., changes
to the performance specifications, the
dimensional specifications, and the
software/firmware, may not require a new 510(k)
if:
– They do not affect the indications for use;
– They do not require supporting clinical data on safety and
effectiveness for purposes of determining substantial
equivalence; and
– The results of design validation do not raise new issues of
safety and effectiveness
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Mechanisms to Implement
510(k) Changes

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“New” 510(k) Paradigm for Alternate
Approaches to Market Clearance
• “The New 510(k) Paradigm” (March 20, 1998) --
offered manufacturers two new optional approaches
for obtaining clearance:
(1) the “Special 510(k): Device Modification”
(2) the “Abbreviated 510(k)”
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Special 510(k): Device Modification
• May be possible, if a new 510(k) is required for a
device modification and if the change does not:
– affect the intended use of the device; or
– alter the fundamental scientific technology of the device
• Depends on ensuring change done in conformity
with the design control provisions of the QSR
regulations.
– The company must conduct a risk analysis and the necessary
verification and validation activities to demonstrate that the design
outputs of the modified device meet the design input requirements
– The submission must include a concise summary of the company’s
design control activities and a Declaration of Conformity with the
design control requirements
more …
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Special 510(k): Device Modification …
• The basic content requirements of a 510(k) remain the
same, but the intent is that less data will be required in
the 510(k) than in the past to support the change
• FDA generally processes Special 510(k)s within 30 days
• Not usually appropriate if clinical data or significant
preclinical data is needed to support the change
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Abbreviated 510(k)s
• Device manufacturers may submit an Abbreviated
510(k) when:
– a device-specific guidance document exists;
– a special control has been established; or
– FDA has recognized a relevant consensus standard
• Abbreviated 510(k) that relies on a guidance
document and/or special control(s) should
include a summary report that describes how the
guidance document and/or special control(s) were
used during device development and testing
more …38

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Abbreviated 510(k)s
• Abbreviated 510(k)s that rely on a recognized
standard should include a declaration of
conformity to the standard instead of the
summary report
• 510(k) must include the required elements of a
premarket notification
• Not a widely-used mechanism
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510(k) Review

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FDA Review of 510(k)
• 90-day review clock
• FDA Actions on a 510(k) Notice
– Refusal to Accept
– Substantially Equivalent (SE)
– Request for Additional Information
– Notice of Withdrawal
– Not Substantially Equivalent (NSE)
– 510(k) Not Required
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocume
nts/ucm089738.pdf
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Refusal to Accept 510(k)
• Four bases to refuse to accept a Premarket
Notification submission:
– Product is not a device in accord with the Federal Food,
Drug, and Cosmetic Act, Section 201(h).
– Premarket notification -- not required under 21 CFR
807.
– 510(k) omits a critical section of the 510(k) submission
required under the implementing regulations or as a
matter of policy.
– 510(k) fails to address scientific and technical issues
clearly described in publicly available general, device-
specific, or cross-cutting guidance documents.
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FDA Actions on 510(k) Notice
• Substantially Equivalent (SE) letter:
– Device meets criteria for SE
– Rare on first round
• Request for Additional (AI):
– When the 510(k) lacks information necessary for the agency to begin,
continue, or complete the review and make a determination as to whether
the device is SE or NSE
– Can be formal or informal
– Formal request stops the 90-day review clock, re-starts upon submission of
information
• Notice of Withdrawal
– If company does not submit AI within timeframe
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FDA Actions on 510(k) Notice
• NSE decision – typically because:
– No predicate device exists
– New intended use
– Different technological characteristics that raise different
questions of safety and effectiveness
– New indications for use or different technological
characteristics and performance data do not demonstrate
device is as safe and effective
• 510(k) Not Required
– Not a device, or 510(k)-exempt
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What to Do if Your Device is Found
NSE?

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Do Not Forsake …
• If an NSE decision is reached, the manufacturer
may not go to market. Options then may include:
– Informal “Appeal”
– Resubmit another 510(k) with new information or data
– “De Novo Process”
– File reclassification petition
– Submit a PMA
• Exploring reasons for NSE decision are the key to
deciding which course of action to take
• Informal consultation with FDA, possibly followed
by a meeting if necessary46

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De Novo Review – Evaluation of Automatic
Class III Designation
• Since 1997, FDA permits manufacturers of certain novel,
low risk devices to request that the agency reconsider
automatic class III determinations (i.e., a determination
that a medical device is a class III device because it lacks
a legally marketed predicate device)
• Intended for novel, but low to moderate risk devices – that
can be handled under Class II or I
• “De novo classification” procedure can be invoked at any
time; used to be after an NSE decision
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De Novo Petition
• Required elements:
– A description of the device
– Any available data from human experience with the
device
– Risks and benefits of the device
– General and special controls the submitter believes
applicable to the device
– Submitter’s recommendation for placement into Class I
or Class II
– Reasons for the classification the submitter
recommends
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De Novo Petition …
• If FDA grants the request, the device is permitted to
enter commercial distribution in the same manner
as if 510(k) clearance had been granted
• Can be used as a predicate in future 510(k)
submissions
• De novo process is under reform
– New draft guidance
– FDASIA -- eliminated need to file a 510(k) and getting the
NSE determination
• Matrix of de novo petitions – 1998 to 2012
– http://www.fdacounsel.com/files/De_Novo_Decisions_--
_1998_to_20123.xlsx
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Lessons Learned:
Seeing the 510(k) from the
Reviewer’s Perspective

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Lessons Learned
• Every reviewer cannot be an expert on every
topic
– Assuming too much knowledge causes delay, BUT
– Don’t reinvent the wheel
• Creative predicate arguments can make a
difference
– Don’t expect FDA to do the predicate research for you or
advise if better predicates are available, BUT
– If FDA makes a suggestion about a predicate to use or to
avoid -- generally, should take it
– FDA will sometimes express discomfort with previously
cleared predicates, e.g., due to off-label use
more …
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Lessons Learned …
- Don’t gloss over key differences in technology—
you are leaving the reviewer the hard work
- A 510(k) is not an epic novel . . . BUT
- Including detail on issues the reviewer is very likely to
raise may eliminate a round of review
- Focus on key areas of technological difference
- Not all technological features need to be discussed if there
is no issue
- Walking the reviewer through the entire 510(k) flow chart
is important -- the reviewer will need to complete this
exercise to reach a decision
more …52

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Lessons Learned …
• Choose wording of both intended use and indications for
use carefully
• Avoid implied claims of superiority/clinical performance
unless there is strong supporting data
• Stray statements in 510(k) or labeling can contradict the
substantial equivalence argument – be careful
• Check your own website for similar claims before filing
Example: 510(k) says nothing new -- web site says “a revolutionary advance
in the treatment of XX”
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Lessons Learned …
• Look critically at the predicate indications
– 513(i)(1)(E) restrictions on predicates mean your device will
have same restrictions
– Concerns about off-label use can cause delay
– If the wording of the predicate indications looks unusually
specific or unusually general, may suggest that the claim had to
be carefully negotiated with FDA
• Respond to all requests for additional information as
quickly as possible, bearing in mind reviewer’s
deadlines, or communicate expected timeline for
response
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Lessons Learned …
• Critically review all performance test reports
• Common pitfalls in testing:
 Insufficient sample size
 Device changed since test performed, or finished, sterile product
not used
 No/inadequate justification for device size/model testing
 No/inadequate rationale for test conditions
 No/inadequate clinical rationale for acceptance criteria
 No/inadequate justification for deviation from applicable
standards
 Direct comparison to predicate not performed
 Outliers excluded without justification
 Report contains extraneous information such as “design could be
improved by doing XX, but costs too much”
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Lessons Learned …
• Compare product labeling to predicates and be
prepared to explain differences in warnings,
precautions, contraindications
• Check off the “RX” or “OTC” box on the
indications for use form
• Have someone not involved with the development
of the device and data review the 510(k) before
finalizing
• Provide an electronic copy
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Lessons Learned …
• 510(k) Summary or Statement
– Summary often better -- Lengthens time to release of full
510(k)
– Be strategic in content/detail; FDA will require substance,
but no need to give away all details of test methodology
 Recently, FDA is requesting more detail in 510(k)
Summaries
Organization of the 510(k) is very important:
sloppy = delay
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Recent Trends - 510(k) Reform

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Recent Trends
• User fees have tightened timeframes
– Reviews generally cannot go on as long
– Higher likelihood of NSE or request to withdraw if issues
cannot be resolved in one or two cycles
– More interactive and informal discussions
– No review starts until user fee is paid
• Greater scrutiny of instruments/accessories
• Less acceptance of “promissory notes”
– E.g., completion of sterilization validation more likely to be
required, for products supplied sterile
more …
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Recent Trends
• Significant increase NSE decisions
• Increasing resistance to combination predicate
arguments
– Effort to eliminate use of “split predicates”
– Resistance to use of combinations of technological
characteristics from different devices (“multiple predicates”)
– Higher levels of data required to address differences between
new device and predicates
– Bumping companies into PMA realm or de novo down
classification
• Software level of concern (LOC) -- minor LOC often
reclassified to moderate60

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Recent Trends -- Data Requirements
• Increasing data requirements overall and also to
address differences between new device and
identified predicate devices
– Bench Data
 FDA requesting additional data not required for predicates,
including clinical data, even when predicate is an earlier
version of the same device
 Requesting statistical rationale for sample size
more …
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Recent Trends – Data Requirements …
– Animal Studies
 FDA has a number of specific people dedicated to the review of
animal studies
 More emphasis on conducting studies under Good Laboratory
Practices (GLP)
 Requesting statistical rationale for sample size
– Clinical data
 Number of 510(k) notices requiring clinical data to support
clearance has increased
 Increasing level of data required for clinical studies
 FDA requiring post-market studies in certain cases
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510(k) Reform
• 510(k) Guidance –
– Draft Guidance for Industry and Food and Drug
Administration Staff - The 510(k) Program: Evaluating
Substantial Equivalence in Premarket Notifications [510(k)]
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDoc
uments/ucm282958.htm
 Greater restrictions on the ability to use multiple predicates, including new "reference device"
concept
 Revised standard for when changes in indications for use constitute a new
intended use
 Increased likelihood that differences in indications for use between the new
device and the predicate will result in a NSE determination
 More detailed information required in 510(k) summaries that will be subject to
FDA verification
 Increased limitations on the use of the Special 510(k) application when animal
and performance data are submitted to support the device modifications
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510(k) Reform …
• Other Key new guidance documents under this
initiative:
– 510(k) Device Modifications: Deciding When to Submit a 510(k) for a
Change to an Existing Device (July 27, 2011) – “revoked” by FDASIA
– De Novo Classification Process (Evaluation of Automatic Class III
Designation) (October 3, 2011)
– SOP: Management of Review Staff Changes During the Review of a
Premarket Submission (December 27, 2011)
• Information and links on FDA Plan of Action on
510(k):
– http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHRep
orts/ucm239448.htm
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Questions?
• Call, e-mail or fax:
Michael A. Swit, Esq.
Special Counsel, FDA Practice
Duane Morris LLP
San Diego, California
direct: 619-744-2215
fax: 619-923-2648
cell: 760-815-4762
maswit@duanemorris.com
• Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
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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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The 510(k) Process

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