510(k) workshop - medical devices group · slide 1 of 65 rob packard, president [email protected]...

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Rob Packard, President

www.MedicalDeviceAcademy.com

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510(k) Workshop

http://www.medicaldeviceacademy.com/

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Your Presenters

Rob Packard Maren Nelson Nancy Knettell


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Agenda

• Overview• Device Classification• Predicate Selection• Table of Contents• Team Member Selection• Intended Use / Indications for Use• Performance Testing Plan• FDA Pre-Sub Meetings• Substantial Equivalence• New RTA Guidance


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Device Submission Types

• 510(k) Exempt, Registration & Listing only

• 510(k)

• De Novo Application

• PMA

• 513(g) Submissions


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510(k) Exempt

• No 510(k) Submission Required

• Registration & Listing Only

• Class I & some Class II Devices


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510(k) Submission• Submission Fee - $5,228 / $2,614

• New Fee for Re-submission after NSE Letter

• No fee for pediatric only submissions


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De Novo Applications• No Fee for De Novo Applications

• Traditionally was extremely common for In Vitro Diagnostic Devices with nearly identical technological characteristics, but different intended use (i.e., different disease)

• Two Possible Routes:

– Submit after NSE (K number is assigned)

– Initial Submission (DEN number is assigned)

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm



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PMA Submissions

• Clinical Studies Required

• 2+ Years for Modular Submission– 1st Ever submission is free

– Small Business Fee is $65,347

– Standard Fee is $261,388

• More rigorous review for approval

• Supplements required for pre-approval of changes

• Pre-approval inspection required

• Time delays are more significant than $


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513(g) Submission• 2012 Blog - http://medicaldeviceacademy.com/fda-device-classification/

• FDA response within 60 days of receipt

• Standard Fee = $3,529

• Small Business Fee = $1,765

• Non-binding, but can be referenced in submission



http://medicaldeviceacademy.com/fda-device-classification/


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510(k) vs. De Novo TimelineDay 1: FDA receives De Novo Application

By Day 7

FDA sends Acknowledgement LetterORFDA sends Hold Letter if unresolved issues with eCopy

By Day 15

FDA sends Acceptance Review

FDA informs submitter if De Novo Application is accepted for Substantive Review or placed on RTA Hold

By Day 90

FDA conducts Substantive Review

FDA communication via a Substantive Interaction

By Day 120

FDA grants De Novo


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RTA Checklist

11

http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm315014.pdf



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Design Controls

User Needs

Design Input

Design

Process

Design

Output

Medical

Device

VALIDATION

VERIFICATION

REVIEW

“Waterfall Diagram”

• 820.30h) – Design Transfer• 820.30j) – Design History File (DHF)


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Stage / Gate Design Process

ProductLaunch510(k)

Design Transfer

ConceptPhase

FeasibilityPhase

DevelopmentPhase

PilotPhase

ReleasePhase

DHFBegins

DesignFreeze


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Design History File (DHF)“Design & Development Files”

21 CFR 820.30j (ISO 13485:2016, Clause 7.3.10)• Each manufacturer shall establish and maintain a DHF for

each type of device.• The DHF shall contain or reference the records necessary to

demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

• Create and maintain a design and development file for each medical device type or medical device family

• Shall include:– Reference to records generated to demonstrate conformity to the

requirements for design and development and records for design and development changes


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Design Controls…When?

• Excluded for contract manufacturers

• Develop and Start Using Draft Forms prior to implementation of Document Control

• Should be your 1st Quality System Process

• Retroactive implementation is not uncommon


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When to Start a DHF?

• After the design plan has been developed

• Upon approval of the design project

• It’s not uncommon to start a DHF late and to retroactively assemble the file from documents that were already created in team meetings.


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When to Complete a DHF?

• After the product has regulatory approval

• Do not keep the DHF open post-release, because subsequent changes should be controlled more rigorously than pre-release design changes

• DMR/TF Index references each post-release design change


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Recommended DHF Contents

• Design Plan• User Needs• Design Inputs• Design Outputs – including labeling• Verification Plans, Protocols & Reports• Validation Plans, Protocols & Reports• Process Validation & work instructions• Design Review Meeting Minutes• Design Requirements Matrix/Traceability• Risk Management File• Initial PMS Plan• Clinical Data Summary and/or Clinical Evaluation Report• Initial DMR/TF Index• Regulatory Approval

Organize Chronologically


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Terminology Alignment

• Verification is confirming the Design Output meets the Design Input

• Process validation confirms that the manufactured product meets the Design Output


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Verification Terms

• “PER” – Production Equivalent Representation• “NPSV” – Non Product Software Validation• Inspection

– Direct examination of PER, e.g. “green” or a label symbol

• Analysis– Indirect evaluation of PER using a documented process, e.g.

SPICE, tolerance analysis, thermal analysis

• Demonstration– Typically for sample size of 1 with a documented protocol, e.g.

power on, display of a message (no variance), yes/no

• Test– Used for PER with variance. Required rationale for sample size,

protocol, or ranges. Battery life, power use, drop.


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Verification Planning

• Identify the requirements

• For each requirement– Identify the verification owner

– Identify the best approach to verification (I, A, D, T)

– Estimate protocols

– Identify standard equipment and fixtures

– Identify custom equipment and fixtures

• Create traceability matrix for verification->requirements

• Create timeline for developing protocols and fixtures


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Verification Development

• Create any needed protocols

• Identify equipment, tools, and fixtures needed

• Develop tools and fixtures, and purchase or check equipment

• Identify criteria for and select suppliers

• Validate tools and fixtures (NPSW)

• Dry run all protocols and verification activities


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Required Before Starting

• Product Requirements Controlled

• Design Specifications Controlled

• Verification Plan Controlled

• Verification Protocols Controlled

• Verification Tools and Fixtures Specified and Controlled

• PER Controlled


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Good Ideas Before Starting

• Approval/review of Product Requirements

• Approval/review of Specifications

• Dry Run of ALL Verification Activities

• Verification Tools and Fixtures Validated

• Equipment Checked for Current Calibration

• PER matches Specifications


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Verification Execution

• Ensure all requirements are verified

• Raw information recorded should always be saved

• If information is copied, keep the originals as well

• Log all equipment, tools, and personnel involved in the verification activities

• Verify equipment used is within the calibration cycle

• Note any variances from plans or protocols


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Verification Report

• Best case

– Report states everything in the plan was done

– Clear statement that the verification was successful

• More typical

– Identify all issues and corrections (which are also variances) and include rationale for acceptability

– Identify all other variances and include rationale for acceptability


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Maintaining Effectiveness

• May use an index instead of a binder(s).

• Look at full scope of DHF index for changes.

• Document regression analysis.

• Track when requirements were last verified.

• If procedure (SOP) changes are made, review against previous releases.

• Maintain documents as controlled documents.


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Helpful Resources

• http://bit.ly/DesignControlGuidance

• http://bit.ly/Design-Planning-Article

• http://bit.ly/MDAtechfile

• http://bit.ly/MDAriskmgtfar

• http://bit.ly/design-control-blogs

• http://bit.ly/riskblogs

• http://bit.ly/ReportDesignChanges


http://bit.ly/Design-Planning-Article

http://bit.ly/Design-Planning-Article

http://bit.ly/MDAtechfile

http://bit.ly/MDAriskmgtfar

http://bit.ly/design-control-blogs

http://bit.ly/riskblogs

http://bit.ly/ReportDesignChanges

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Product Classification

• Identify a device similar to yours

• Use the registration and listing database

• http://bit.ly/CDRH-Registration-Listing-Database

• Identify the 3-letter product code

• Click on the code to go to the product classification page

• Click on the TPLC link http://bit.ly/FDATPLC



http://bit.ly/CDRH-Registration-Listing-Database

http://bit.ly/FDATPLC


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Find Classification Other Wayshttp://bit.ly/ProductClassification


http://bit.ly/ProductClassification

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Predicate Selection

• Is the predicate device legally marketed?• Do the devices have the same intended use?• Do the devices have the same technological

characteristics?• Do the different technological characteristics raise

different questions of safety and effectiveness?• Are the methods of evaluating new/different

characteristics acceptable?• Does the data demonstrate substantial

equivalence?


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How FDA Evaluates SE?http://bit.ly/Substantial-Equiv-Guidance


http://bit.ly/Substantial-Equiv-Guidance

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Section 2 - Table of Contents

• 20 Sections

• Create a Template (http://bit.ly/510k-ToC)

• eCopy Guidance (http://bit.ly/FDA-eCopy)

• RTA Checklist (http://bit.ly/Acceptance-Checklist)

http://bit.ly/510k-Format


http://bit.ly/510k-ToC

http://bit.ly/FDA-eCopy

http://bit.ly/Acceptance-Checklist

http://bit.ly/510k-Format

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Section 2 - Table of Contents

20 sections mirror 510(k) Submission


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Benefit-Risk Determination• Summary of Benefits

– type of benefits– magnitude of benefits– probability of patients experiencing one or more benefit– duration of beneficial effects

• Summary of Known Potential Risks to Health– Hazard Identification

• Risk Estimation– severity of injuries– type of injuries– number of injuries– frequency of events– probability of events resulting in injury– duration of harmful events– probability of false-positive and false-negatives for diagnostic products

• Risk Controls (i.e., mitigations)• Testing Standards = Design Inputs• Verification of risk control effectiveness

• Benefit-Risk Considerations

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf


http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf

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Use ToC as Planning Tool

• red = the information does not appear to be available

• yellow = document requires revision and/or reformatting of content

• blue = ready for the client’s review and approval

• green = ready for submission

• Add a column to assign team responsibilities

• Prioritize task completion


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Example of ToC ToolSection # Description of 510(k) Section Comments Assigned To Target Completion Date

1 Medical Device User Fee Cover Sheet (Form FDA 3601) Missing Client

2 Table of Contents Missing Rob Packard

3

510(k) Cover Letter & CDRH Premarket Review

Submission Cover Sheet

May want to add a confidentiality statement and

need to include coverletter Client

4 Indications for Use Statement

Does not match the predicate - is this more

narrow or just different Rob Packard

5 510(k) Summary or 510(k) Statement

You have both and only need one; there is a new

guidance for 510k summary Client

6 Truthful and Accuracy Statement ok - must be signed Client

7 Class III Summary and Certification need to explain why it's not applicable Rob Packard

8 Financial Certification or Disclosure Statement need to explain why it's not applicable Rob Packard

9 Declarations of Conformity and Summary Reports

Need all the form 3654s completed for each

applicable standard and a summary document--

ideally in tabular format Rob Packard

10 Executive Summary Need to review in detail, but looks good Client

11 Device Description

You might want these to be documents

referenced rather than embedded figures TBD

12 Substantial Equivalence Discussion

Needs lots of work to comply with current

guidance - July 24, 2014 Rob Packard

13 Proposed Labeling

Needs to include PDF of labels and IFU; IFU

needs to include indications for use and it must

match Section 4 exactly Client

14 Sterilization and Shelf Life Missing TBD

15 Biocompatibility Missing TBD

16 Software need to explain why it's not applicable Rob Packard

17 Electromagnetic Compatibility and Electrical Safety need to explain why it's not applicable Rob Packard

18 Performance Testing – Bench

Missing - should include simulated use--maybe

with an anotomical "dummy" TBD

19 Performance Testing – Animal need to explain why it's not applicable Rob Packard

20 Performance Testing – Clinical need to explain why it's not applicable Rob Packard

21 Other N/A N/A


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Team Member Selection

• Boilerplate – 1, 3, 6 & non-applicable

• 9 - Declarations of Conformity (FDA Form 3654)

• Biocompatibility & Sterility – 14 & 15

• Software & EMC – 16 & 17

• Labeling - 13

• Performance Testing– Bench Testing - 18

– Animal Testing - 19

– Clinical Studies – 20 + Sections 7 & 8


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Most Critical Sections

• 4 – Indications for Use (1st)

• 5 - 510(k) Summary (4th)

• 10 – Executive Summary (my last)

• 11 - Device Description (2nd)

• 12 – Substantial Equivalence (3rd)

• RTA Checklist is a great quality


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Why I Prepare Section 4 First

• This section is short and mandatory.

• This section can be completed even if the design is in progress.

• The header identifies the title of the submission which will be used in all other sections.

• The content identifies the proposed primary predicate.

• The content identifies the indications for use stated in the applicable regulation.


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Where the Indications for Use Appear

• 510(k) Cover letter

• Vol 4 – Indications for Use

• Vol 5 – 510(k) Summary

• Vol 9 – Declaration of Conformity & Summary Reports

• Vol 10 – Executive Summary

• Vol 11 – Device Description

• Vol 12 – Substantial Equivalence

• Vol 13 – Labeling (must appear in the IFU)


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Content of Volume 4, Doc 1

• Copy of Indications from Applicable Regulation

• Copy of Indications from Primary Predicate

• Copy of Indications for Subject Device

• Reference to Volume 4, Doc 2 (FDA Form 3881)


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Case Study Example

• Topical skin adhesive

• Special controls guidance

• Multiple predicates to choose within the MPN product code

http://medicaldeviceacademy.com/510k-submission-fda-case-study/


http://medicaldeviceacademy.com/510k-submission-fda-case-study/

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21 CFR 878.4010


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Indications from Regulation“A device intended for topical

closure of surgical incisions,

including laparoscopic incisions,

and simple traumatic lacerations

that have easily approximated skin

edges. Tissue adhesives for the

topical approximation of skin may

be used in conjunction with, but

not in place of, deep dermal

stitches.”


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Primary Predicate510(k) Summary

If the company submitted a 510(k) Summary after February 1996, then the Indications for Use page will be included in the 510(k) Summary as a single page.

If the company submitted a 510(k) Statement, then you will need to find the Indications from another source:

Option 1 – request a copy of submissionOption 2 – search their website


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Indications fromPrimary Predicate

“Surgiseal™ Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

Surgiseal™ Topical Skin Adhesive may be used in conjunction with, but not in place of, dermal sutures.”


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Indications for Subject Device

“Krazyseal™ Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.

Krazyseal™ Topical Skin Adhesive may be used in conjunction with, but not in place of, dermal sutures.”


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Where to DownloadFDA Form 3881

http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm360431.pdf

You need Adobe Acrobat to complete this in a way that you can make changes and save as a PDF.

Otherwise you need to print and scan from Adobe Reader.


http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm360431.pdf

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Planning Performance Testing

• Look for a special controls guidance document 1st.

• Look for any device-specific standards (e.g., ASTM F483)

• Review each of the possible 510(k) Summaries carefully

• Order 510(k) submissions through FOI


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Bench Testing

• ASTM testing methods

• Simulated use experiments

• Validation tools (known input data for software/hardware devices)

• Finite Element Analysis (FEA)

• Cadaveric studies


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Animal Studies

• The agency allows rationales for reduction of sample number in order to spare the lives of animals.

• Try to find another submission or 510(k) summary that specifies the number of animals

• Test more than once per animal or your device and the predicate in each animal (i.e., animal is it’s own control)

• Small animal vs. large animal and duration…


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Human Studies

• 10-15% of 510(k) submissions require clinical study data

• Steps:– Study Synopsis

– Investigator Package

– Protocol Approval

– Conduct Study

– Summary Report

• Non-significant risk studies do not require IDE

• IRB approval is always required

• Paper data collection vs. electronic data collection


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What is a pre-sub meeting?

• A meeting with the FDA in order to ask questions specific to a planned regulatory submission:– 510(k) Application

– De Novo Application

– Investigation Device Exemption (IDE)

– Pre-Market Approval (PMA)

• Usually a one-time meeting rather than iterative


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Guidance

• The Pre-Submission Program and Meetings with FDA Staff

– Draft guidance issued July 13, 2012

– Final guidance issued February 18, 2014

• Supersedes Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1, dated March 25, 1999




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Not Just for Pre-IDE

• Pre-sub meetings are not used just for preparing an Investigational Device Exemption (IDE) Submission

• Other Uses:– De Novo Submissions

– Review of Draft Special Controls

• Pre-Subs tracked as “Q Submissions”

• Meetings Upon Request – 75-90 Days from the date of Submission

http://www.fda.gov/downloads/training/cdrhlearn/ucm387291.pdf


http://www.fda.gov/downloads/training/cdrhlearn/ucm387291.pdf

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Is a pre-sub meeting required?


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Submission Logistics

• 1 eCopy (http://bit.ly/FDA-eCopy) & 1 hardcopy

• Cover letter Content– Identify submission as “Pre-sub Meeting Request”

– Sponsor Contact Info

– Device Name

– Information specific to Q-Sub type (Should be “Pre-Submission”)

Address:

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Document Control Center –WO66-G609

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

DCC = Document Control CenterTLA = Three Letter Acronym


http://bit.ly/FDA-eCopy

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When to have a pre-sub?

Earliest Time

When you have reviewed and approved your design inputs.

Latest Time

At design freeze.

Before a long-term clinical study.


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Integrating Pre-Sub w/Design & Risk Plans

DHFBegins

ProductLaunch510(k)

Design Transfer

ConceptPhase

FeasibilityPhase

DevelopmentPhase

PilotPhase

ReleasePhase

HazardIdentification

Risk ControlOption Analysis

RiskAssessment

Risk ControlEffectivenessVerification

RiskManagement

Plan

Risk / BenefitAnalysis

Risk ManagementReport

DR


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Pre-Sub Timeline

• RTA Process (0-14 days)– Does request qualify as a pre-sub?– Is submission sufficiently complete?

• Contact Submitter to schedule date/time of meeting (15-21 days)• Submit agenda for meeting

– allot last 10 minutes to summarizing discussion and action items

• FDA Provides preliminary feedback 3-days prior to the pre-sub meeting (sometimes meeting is cancelled)

• FDA Provides feedback (75-90 days)• Sponsor provides draft minutes to DCC (15 days)• FDA reviews/edits draft meeting minutes (30 days)• May present courtesy copy to reviewer of final meeting minutes.


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Basics of a Pre-sub

• Provide several options for dates to remain flexible

• Agenda should limit presentation of information to approximately 1/3 the allotted time for meeting

• Clear and concise background information

• Specific questions for FDA

• If for a clinical study (NSR, IDE or OUS), then entire protocol may be submitted


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General Content of a Pre-sub

• Cover letter• Table of contents• Device description• Proposed Intended/Indications for Use• Previous discussions or submissions• Overview of product development• Specific questions• Method for feedback

– in-person meeting– a teleconference– Fax– email


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510(k) Content for Pre-Sub

• Proposed predicate device(s)

– Trade name & model number

– 510(k) number

– Classification of the predicate device

– Comparison of predicate(s) with subject device

• Indications for Use

• Technological characteristics

• Performance testing

– Performance Testing


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Proposed Test Plan Details

• objective or purpose of the test

• explanation of the sample size and statistical methods

• summary of the test methodology (if you are following a recognized standard, include the name of the standard and year of publication)

• explanation of study endpoints

• explanation of study acceptance criteria


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Do not include test results & data


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If requesting in-person or tcon

• three (3) or more preferred dates and times when you are available to meet using the guidelines in Table 1 above for scheduling;

• the planned attendees, including each attendee’s position, or title, and affiliation. If you have not yet identified all of your attendees, you should indicate the type of subject matter experts you plan to invite so that we can ensure appropriate FDA experts are in attendance. Please note foreign visitors meeting in an FDA facility require advanced security clearance. See Section IV. B. “Security Screening” below for additional information on how to request security clearance for Foreign Nationals; and

• a list of any audiovisual equipment you will need, such as conference phone or LCD projector.


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Pre-Sub Questions

• Is justification of no carcinogenicity testing acceptable?

• Does FDA agree with “worst-case” rationale?

• Is software “moderate level of concern”?

• Is planned approach for human factors acceptable?

• Are there concerns of predicate selected?


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IVD-Specific Considerations

• Request a pre-sub before conducting clinical, nonclinical, or analytical studies or submitting a marketing application for a new IVD that:– Is a multiplex device capable of simultaneously testing a

large number of analytes– Contains a new technology– Has a new intended use– Includes a new analyte– Presents new clinical questions– Presents complex data/statistical questions– Uses a predicate or reference method that is unclear or

uncertain


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Preparing for a Pre-Sub

• Do your homework 1st.• Prepare documentation early and submit with Pre-Sub meeting

request – including proposed agenda• Practice your questions and responses to potential questions by role

playing• Submit focused questions in advance• Develop the agenda based on these questions• Bring the right experts to execute your objectives• Have an expert present that can “kick you”.• If you are visiting the FDA in-person, be sure to arrive 30 minutes

early. FDA will greet you 10 minutes prior.• You will need ID for in-person meetings.• Have a dedicated scribe to take notes.


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Clinical Study:Agreement on Study Size

• Never ask how many patient subjects

• Always suggest a study design instead– Present Clinical Synopsis– Or a Clinical Protocol– Include non-clinical data– Include similar clinical studies with the same device, but a

different indication

http://medicaldeviceacademy.com/clinical-procedure/

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812


http://medicaldeviceacademy.com/clinical-procedure/

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812

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What not to do for Pre-Sub…

• Do not request a meeting just to give the FDA info• Do not ask the FDA to help suggest performance bench

testing or animal studies• Do not ask the FDA to help design a clinical study• Do not ask questions that can be directed to the reviewer• Do not ask for classification decision – 513(g)• Do not ask for designation of jurisdiction (RFD)• Do not ask for determination on a submission• Do not ask for agreement on clinical data requirements• Do not ask if data is acceptable• Do not bother if you already did your testing




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Non-Binding Feedback

FDA intends to stand behind our feedback unless:

• Information in subsequent submission is not consistent with pre-sub (e.g., change in proposed indication for use or device design)

• Data in the subsequent submission raise important new issues related to safety and effectiveness (e.g., a study is conducted as recommended by FDA, but results raise new safety concerns)

• Feedback given previously does not adequately address important new issues materially relevant to a determination of safety or effectiveness that have emerged since the time of the pre-sub (e.g., new alternative therapies/diagnostics have emerged since discussion of the clinical protocol making the previously recommended study design unethical)


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Meeting Minutes

• A summary—not a transcript

• No responses to FDA feedback

• Follow-up requests– Submit a Q-Sub Supplement instead

• Submit draft meeting minutes to DCC

• FDA edited version becomes final within 15 days, unless sponsor submits “minutes disagreement amendment”…not a disagreement with feedback, but a disagreement with what was said


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Disagreement with FDA

• Do not argue, because you don’t have to agree with the agency.

• Summarize action items at the end and ask for clarification.


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Risk / Benefit Ratio

• Are there any risks to having a pre-sub meeting?

• What are the benefits of a pre-sub meeting?


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6 Questions1. Is the predicate device legally marketed?

2. Do the devices have the same intended use?

3. Do the devices have the same technological

characteristics?

4. Do the different technological characteristics

raise different questions of safety and

effectiveness?

5. Are the methods of evaluating new/different

characteristics acceptable?

6. Does the data demonstrate substantial

equivalence?


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Legally Marketed?

Registration and listing database


A 510(k) is not enough!



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Same Intended for Use?

• Compare with Applicable Regulation

• Compare with Primary Predicate

• Carefully Justify Differences with Subject Device

– More Narrow Scope

– Broader Scope


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Technological Characteristics?

• Materials

• Design

• Energy Source

• Other Features

• Same ≠ Equivalent

– Does not raise DIFFERENT issues of safety or effectiveness

– Must be as safe and effective as predicate


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Split Predicates

• 1st Predicate has same intended use

• 2nd Predicate has same technological characteristics

This is not allowed.


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Multiple Predicates Allowed…

• Option 1:

– Two predicates with different technological characteristics, but the same intended use

• Option 2:

– A device with more than one intended use

• Options 3:

– More than one indication under the same intended use


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Examples

• Example 1 – Hemodialysis catheter– Predicate A has same extension design

– Predicate B has same tip design

– Both A & B predicates have the same intended use

• Example 2 – Fracture fixation plate– Predicate A is indicated for middle bone fractures

– Predicate B is indicated for bone tip fractures

– Both A & B predicates are intended for long bone fractures

– New performance testing may be required


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Examples (continued)

• Example 3 – Laser hand piece– Predicate A Er:YAG laser hand piece

– Predicate B Q-Switch Nd:YAG laser hand piece

– Both A & B predicates have the same general intended use of lasers: “incision, excision, ablation, vaporization of soft tissue.”


– A single predicate could have been used, but the inclusion of a second predicate is helpful in establishing substantial equivalence with regard to specific indications and technological characteristics.


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• Example 4 – Multi-parameter monitor

– New monitor includes different technologies

– Predicate for each parameter

– Monitoring of each parameter cannot interfere with the others



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• Example 5 – Temperature measuring urinary catheter

– Urinary catheter is primary predicate

– Thermometer is secondary predicate added as a convenience

– Two predicates fall under different classifications

– The additional feature cannot alter the risk profile of the urinary catheter


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Use of Reference Device

• Must first pass decision point questions 1-4

• Example of a knee implant with a new coating:

– Predicate is a legally marketed

– Predicate has the same intended use

– Predicate has different technological characteristics (i.e., the coating)

– Predicate and subject device have the same questions of safety & effectiveness (i.e., biocompatability)
