FDLI s Workshop on
Introduction to Medical Device Law and Regulation:
Understanding How FDA Regulates the
Medical Device Industry
510(k) Premarket Notifications
Presented by
Suzan Onel, Partner
January 26, 2006
779562 www.klng.com

FDA Classification Regulations Organized by
Medical Specialty
Specific Regulation for each Category of
Device
Identification
Classification
Exemption, if any, from requirements
(e.g., GMP, 510(k))
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Marketing Of A Device Cannot Occur Until:
The Device is a pre-1976 Grandfathered
Device or has been Exempted from the
510(k) Requirement; or
Device has a Cleared 510(k); or
Device has a Premarket Approval.
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The 510(k) Process:
Requires a Pre-Market Submission to FDA and Clearance Order
Approximately 90-Day Review Time
FDA Must Find the Proposed Device to be
Substantially Equivalent to a Predicate
Device
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When to File a 510(k):
New Device First Commercial Distribution of Class I or Class II Device
Old Device, New Marketer Device Already in the Market but by Another Marketer
Old Device with Changes Device Marketed but with Material Changes in Design,
Components, Method of Manufacture, or
Intended Use
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Who Must File a 510(k):
Manufacturers
Specification Developers
Repackers Who Change Device or its
Labeling
Relabelers Who Change Labeling, e.g.,
Instructions for Use
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All Class I Devices
(Unless Intended for a Use of Substantial
Importance in Preventing Impairment of
Human Health or the Device Presents a
Potential Unreasonable Risk of Illness or
Injury)
Specified Class II Devices
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Pre-1976 Grandfathered Devices
Custom Devices If Three Conditions Met:
Not Generally Available for Purchase in
Finished Form
Not offered Through Labeling or Advertising
For Prescription Use (Specific Patient)
Distributor and Repacker If no Change in
Labeling or Device Other than Adding Name as
Distributor
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C. Content Of A 510(k) Submission
1. Substantive Information Requirements
Introduction/Background
General Device Information
Classification Name
Common/Usual Name
Trade/Proprietary Name
Product Code
Classification
Regulation Number
Panel
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C. Content Of A 510(k) Submission
Device Sponsor Information
Sponsor Name
Sponsor Address
Establishment Registration Number (if any)
Official Correspondent
Performance Standards (if any)
Device Description
Drawings/Photographs
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C. Content Of A 510(k) Submission
Predicate Device Information
Predicate Name
Predicate Indications for Use
Substantial Equivalence
Statement of Similarities to and Differences from
Predicate
Performance Data
Software
Bio Compatibility
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C. Content Of A 510(k) Submission
Packaging
Sterilization
Shelf Life
Labeling
Proposed Device
Predicate Device
Truthful and Accurate Statement
Confidentiality (may be in cover letter)
Class III Summary and Certification (if needed)
Appendices, as needed
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C. Content Of A 510(k) Submission
2. 510(k) Summary or 510(k) Statement
510(k) Summary:
Must Include Sufficient Detail to Provide
Basis for S/E Determination
Requirements are Listed at 21 C.F.R.
§807.92
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C. Content Of A 510(k) Submission
510(k) Statement:
Certified Statement Agreeing to
Provide a Copy of Non-Confidential
Portions of 510(k) within 30 Days of
Request from Anyone
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C. Content Of A 510(k) Submission
3.
Confidential Treatment of Information in 510(k)
Nothing Released During Device Review
Process
Trade Secret and Confidential Commercial
Information is not Released
Once Cleared by Order, 510(k) Information
Available through FOIA Request
If a 510(k) Summary is Submitted, Will be
Available on FDA Website Shortly After
Clearance is Granted
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C. Content Of A 510(k) Submission
4. Financial Disclosure Requirements for
Clinical Investigators
Applicants are Required to Either a) b)
Certify that no significant financial arrangements exist between the clinical investigator and the study sponsor (FDA
Form 3454); or
Disclose to the FDA the nature of the financial arrangement (FDA Form 3455)
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C. Content Of A 510(k) Submission
Purpose: To examine financial interests which could bias the reliability and integrity of the clinical data
Includes: Compensation, proprietary interest and significant payments in kind (such as stocks, grants, honorarium, equipment) in excess of 25k
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C. Content Of A 510(k) Submission
5. 510(k) Alternatives
Special 510(k) (Device Modification)
Abbreviated 510(k) (Relies on
Conformance to Standards)
FDA Guidance, The New 510(k) Paradigm:
Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket
Notifications (3/20/98)
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Applicant must establish that the device has the same intended use as a legally marketed predicate and:
1) The same technological characteristics; or
2) Different technological characteristics, but is as safe and effective as a legally marketed device; and
3) Does not raise different questions of safety or effectiveness
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Different technological characteristics means that there is a significant change in the materials, design, energy source or other feature of the device from . . . the predicate device
Can use multiple predicates
Cannot claim substantial equivalence to a predicate device that has been removed from the market (by regulatory action)
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E. FDA Consideration and Review
1.
Typical Procedure and Time Table
File 510(k) Notification at Least 90 Days Before
Marketing
Procedures for How and Where to Submit Described in
Regulations (21 C.F.R. § 807.81-807.94)
FDA Logs in Application and Sends to Applicable
Division
Initial Review for Administrative Completeness
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E. FDA Consideration and Review
Assigned to Reviewer and Review Group for Substantive
Review
Possible Deficiency Letters/Request for Additional
Information May Follow
SE Order Rendered Within Approximately 90 Days
If SE Order Issued, 510(k) Summary Made Public Within
30 Days of Clearance
* Device Cannot be Commercially Marketed in U.S. Until
SE Order is Issued
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E. FDA Consideration and Review
2.
Procedure for Incomplete/Inadequate 510(k)s a) b)
Refuse to Accept Policy
Within 45 days of submittal
FDA checklist
Administrative review to ensure reviewability
NSE Decision
Cannot market in U.S.
Can resubmit 510(k) with new data
Can petition for De Novo review
Can submit a PMA
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3.
Other Issues
Expedited Review
Evidence Suggests Potential for Clinically
Meaningful Benefit Compared to Existing
Alternatives
Device Provides Revolutionary Advance
Generally Not Available for 510(k)s, Though
510(k) Alternatives of Special 510(k) and
Abbreviated 510(k) are Meant to Provide
Expedited Review
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E. FDA Consideration and Review
General/Specific Intended Use
Issue: When does a device cleared for a general indication for use need a new application for a specific indication for use narrower than the cleared general indication?
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E. FDA Consideration and Review
Major Factors Considered in the Assessment:
Level of specificity of claim
Risks
Public health impact
Knowledge base
End points
Tool or treatment
Adjunctive therapy
Design changes
Guidance Provides Examples of Specific Claims SE/NSE to General Indications
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E. FDA Consideration and Review
De Novo Review Upon NSE Finding
All New Devices are Automatically Placed in Class III
FDAMA Allows for De Novo Review and
Reclassification for New Low Risk Devices
FDA Guidance
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E. FDA Consideration and Review
Special Controls
Performance Standards e.g., Electrode lead wires and patient cables
Post-Market Surveillance
Patient Registries
Guidelines
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E. FDA Consideration and Review
Rescission of 510(k)
FDA Has Authority to Rescind a 510(k)
Clearance Order Due to New Safety or
Effectiveness Information
Rarely Done
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E. FDA Consideration and Review
Dispute Resolution
Informal Appeal of Decisions from FDA Reviewer to
Branch Chief, to ODE, to Center Director, to
Commissioner
Formal Appeal Through CDRH Ombudsman of
Certain FDA Decisions or Actions that Represent
Scientific Controversies between the Requestor and
FDA
FDA Guidance
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F. Modifications To A Cleared Device
A New 510(k) Needs to be Submitted When There is:
A Change or Modification that Could Significantly
Affect the Safety or Effectiveness of the Device (e.g., change to design, material, chemical composition, energy source, manufacturing), or
A Major Change to the Intended Use
* Must Consider Incremental Changes ( Device Creep )
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F. Modifications To A Cleared Device
FDA Guidance Deciding When to
Submit a 510(k) for a Change to an
Existing Device (1/10/97)
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Applies Only to FDA Recognized Consensus
Standards (See CDRH Website for List)
May Facilitate/Expedite Review of 510(k) Submission
Conformance is Voluntary
If Submission Includes a Declaration of Conformity,
Data Relating to the Aspects of Safety/Effectiveness
Covered by That Standard Ordinarily Will Not be
Required in the Submission
FDA May Request Additional Information
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Began as a Voluntary Pilot Program in 1996 to Help Speed Review
Time
Codified Under FDAMA
Applies to All Class I, Non-Exempt Devices and Select Class II
Devices
510(k) Submitters Contract with Third Parties to Review 510(k)s for Certain Devices
Third Party Forwards 510(k) to FDA With its Review and
Recommendation
FDA Reviews Record and Must Make Determination Within 30
Days
FDA Guidance Document Lists of Devices Eligible for Third Party
Review, Accredited Persons, and Devices They May Review
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MDUFMA of 2002: Tied User Fees to Performance
Goals
FY 2004-07
New Fee Levels Each Year
Large Company Fee is 1.42% of PMA Fee
FY 2004 - $3,480 (full)
FY 2005 - $3,502 (full)
FY 2006 - $3,833 (full)
FY 2006 - $3,066 (small business)
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MDUFSA of 2005: Redefines Small Business and
Caps Annual Fee Increases
$100 Million Annual Gross Receipts
Copy of Federal Tax Return
Include Affiliates Tax Returns
Certify as True Copies
Certify if No Affiliates
Caps Annual Fee Increases at 8.5%
Requires Full Congressional Funding in FY 06 and 07
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1.
Check Regulatory Classification to Determine if
510(k) is Necessary.
2.
If Required, Do Not Market in U.S. Until 510(k) is
Cleared for Intended Use.
3.
Identify Appropriate Predicate(s).
4.
Use Charts and Tables to Support Claim of
Substantial Equivalence.
5.
Carefully Evaluate Device Improvements to Assess a New 510(k) is Necessary and Document Rationale
When One is Not Necessary.
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