510k Submission Overview

Flu KitOverview
510k Submission
Regulatory Discussion
Myraqa, Inc.
August 22, 2012
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
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
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
What a 510(k) Is Not
• A Form
• Establishment Registration
• Device Listing
• Premarket Approval (PMA)
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;
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
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
Special Controls
• May include special labeling requirements, mandatory
performance standards and post-market surveillance
510(k) Submission Required When?
• Introducing a device to the U.S. market for the first
• Change in indications for use for a previously cleared
• Making significant modification to a previously cleared
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)
Intended Use Statement
• FDA generally regulates devices according to the
intended use – not the technology used to generate the
• 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)
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
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)
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
• 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
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
» 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
Substantial Equivalence (SE)
Device is Substantially Equivalent to predicate if:
» Has the same intended use, and
» Has the same technological characteristics as the predicate
• 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
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
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
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
Thank You

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