Novartis
Flu KitOverview
510k Submission
Regulatory Discussion
Myraqa, Inc.
August 22, 2012
Presenter
October XX, 2010
About Myraqa, Inc.
• Myraqa is the leading IVD
consulting firm
• Headquarters in Silicon Valley
• Clients include IVD
manufacturers, pharma, clinical
labs, investors and other industry
stakeholders
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About Myraqa, Inc.
• Team-Driven Success
» We employ leading experts in IVD Regulatory, Quality,
Clinical, Biostatistics, Development and Marketing
» Team approach best combines diverse expertise
» Team members are employees, not contractors
» All senior staff have at least 15 years of relevant
experience, most have considerably more
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What is a 510(k)?
• Premarket Notification
• Section 510(k) of Federal Food, Drug, & Cosmetic Act
• 21 CFR 807 Subpart E
• Marketing Clearance Application
• Allows FDA to Determine Substantial Equivalence (SE)
• Classification process for a device
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What a 510(k) Is Not
• A Form
• Establishment Registration
• Device Listing
• Premarket Approval (PMA)
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What is a Predicate?
• An identification of the legally marketed device to
which the submitter claims equivalence. A legally
marketed device to which a new device may be
compared for a determination regarding substantial
equivalence is:
» a device that was legally marketed prior to May 28, 1976,
» or a device which has been reclassified from class III to class II
or I (the predicate),
» or a device which has been found to be substantially equivalent
through the 510(k) process;
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Regulatory Classes for Devices
Three Regulatory Classes (level of control based on risk):
• Class I – General Controls
• Class II – General Controls, Special Controls and
Premarket Notification
• Class III – General Controls and Premarket Approval
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General Controls
• Class I devices are subject to the least regulatory control and are
subject to “General Controls”
• General controls include:
» Establishment Registration of companies which are required to
register under 21 CFR 807.20, such as manufacturers, distributers,
repackages and relabelers
» Medical Device Listing with FDA of devices to be marketed
» Manufacturing devices in accordance with current Good
Manufacturing Practices (Quality System Regulation in 21 CFR 820)
» Labeling devices in accordance with labeling regulations in 21 CFR
801 or 908
» Submission of a premarket notification [510(k)] before marketing a
device
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Special Controls
• May include special labeling requirements, mandatory
performance standards and post-market surveillance
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510(k) Submission Required When?
• Introducing a device to the U.S. market for the first
time
• Change in indications for use for a previously cleared
device
• Making significant modification to a previously cleared
device
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Who Must Submit a 510(k)?
• Device Manufacturers
• Specifications Developers
• Repackagers who change device or its labeling
• Relabelers who change the labeling- e.g., instructions for use
• Anyone who both manufactures & distributes
• A company that distributes devices but does not perform any
of the other functions above is not required to submit a 510(k)
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Intended Use Statement
• FDA generally regulates devices according to the
intended use – not the technology used to generate the
information
• Intended use statement
– includes a general description of diseases or conditions that the
device will diagnose, treat, prevent, cure, or mitigate including
a description, where appropriate of the patient population for
which the device intended (21 CFR Part 812.2)
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Systems Approach
• FDA takes a ‘systems approach’ to the regulation of
devices and IVDs
– Reagents, instruments, software – everything that is needed to
produce a diagnostic result must be included
– Can utilize a partnership approach with parallel submissions
• Examples
– Affymetrix/Roche
– CDC/Applied Biosystems
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Device Classifications
• There are three classifications of devices
» Class I: Low Risk
» Often 510(k) Exempt
» General Controls
» Examples: General purpose reagents, Mass spectrometers
» Class II: Moderate Risk
» Require 510(k) clearance before commercialization
» General Controls + Special Controls (e.g., clinical testing)
» Class III: High Risk
» Require Premarket Approval (PMA)
» PMA inspection
Contents of a 510(k)
• Medical Device User Fee Cover Sheet
• CDRH Premarket Review Submission Cover Sheet
• Cover Letter
• Intended Use / Indications for Use
• 510(k) Summary
• Truthful and Accurate Statement
• Financial Certification or Disclosure Statements
• Executive Summary
Contents of a 510(k) (Cont)
• Device Description
» Include all reagents and instruments used
» This is where we give FDA the details on how our product works
• Proposed Labeling
» Will include Package Insert or Operator’s Manual (Instructions for Use)
» Kit and component labeling
• Stability
» Studies conducted and results (Real-Time)
• Software
» Requirements outlined in Software Guidance document
Contents of a 510(k) (Cont)
• Performance Testing
» Analytical/bench testing – Often multiple studies
» Animal testing (if required)
» Clinical testing –external clinical sites (typically 3 site minimum)
» Approximately 10% of all 510(k)s
» Important difference with the predicate device, e.g., new indication for
use or new technology
» Must be collected under Investigational Device Exemption Regulations (21
CFR Part 812)
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FDA 510(k) Review
• FDA recently published Refuse to Accept Policy for 510(k)s, which also
includes administrative checklists for Traditional, Abbreviated and Special
510(k)s.
• Administrative Review
»
Administrative review will be completed within 15 days of receipt of 510(k)
»
Assessment of completeness of 510(k) not the quality of information
• The submitter will be notified in writing if the 510(k) was found
administratively complete or incomplete.
» If incomplete submitter has 30 days to respond to the RTA letter
» either provide the missing information or
» request an extension request for up to 180 days from the date of the RTA letter.
» If complete FDA staff can begin the substantive
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FDA 510(k) Review
• Substantive Review
» Review of content and quality of information submitted
» FDA may request additional information/performance data to determine
substantial equivalence to the predicate
» Reviewer requests by telephone, email or formal letter (from Doc Center)
» Clock stops by letter only
» Submit additional information to Document Mail Center
» 30 days to submit
» May request an extension within 30 days of the request for additional
information
» The request for extension should state the reason and time needed
» The 510(k) may be deleted from the 510(k) tracking system if there is no response to
the request for additional information within 30 days of FDA’s request letter
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Substantial Equivalence (SE)
Device is Substantially Equivalent to predicate if:
» Has the same intended use, and
» Has the same technological characteristics as the predicate
device,
• Or
» Has the same intended use, and
» Has different technological characteristics and the information
in the 510(k):
» Does not raise new questions of safety and effectiveness, and
» Demonstrates new device at least as safe and effective as the
predicate
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Not Substantially Equivalent (NSE)
• There is no predicate device
• Has a NEW intended use
• Has different technological characteristics compared to
the predicate device and raises a new questions
regarding safety and effectiveness
» The NSE determination did not include data review and will
require PMA or De Novo
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Not Substantially Equivalent (NSE) (Cont)
• Does not demonstrate device is at least as safe and
effective as the predicate
» The NSE determination included data review and is eligible
for a new 510(k) with new data
• Approximately 3% are found NSE
• Data is looked at last in the 510(k) regulatory
review process
• FDA usually asks for additional information at least
once prior to determining the device is NSE for lack
of data
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Key Take-Aways
• Review relevant FDA guidance documents and search
the releasable 510(k) database
» 510(k) summaries and decision summaries for similar products
• Use new RTA Checklist
• Confirm regulatory pathway with FDA
» Pre-IDE or Pre-Submission Meetings
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Thank You
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