tips for an effective submission · effective executive summaries this tells the mdb reviewer what...

Tips for an Effective Submission

© Mapi 2014, All Rights Reserved

Shirley Furesz, Ph.D., RAC

© Mapi 2014, All rights reserved2

Overview

Selecting the appropriate licensing pathway for registration in Canada

How to write an effective Executive Summary

How do you know if you have enough clinical evidence? Reviewing clinical evidence

Building clinical evidence using a Substantial Equivalence-like table

Tips/Items for Consideration for a Successful Submission to Health Canada

Appropriate Licensing Pathway



Know and understand the licence types Single Medial Device Medical Device Family A System Medial Device Group Medical Device Group Family Test Kit (IVDDs)

Determine what the classification of the device is (and if you are not sure, ask MDB!!)

Have you checked to see if there are any guidance documents (MDB/FDA issued)?



Steps in determining best path forward:

New licence or amendment? Does the scope of your ISO 13485:2003 CMDCAS

certificate include the new device? Look at the labelling!!

Determine if all components are labelled with the same manufacturer name

See if all components share a common “system” name Look at the Intended Use Statement



Steps in determining best path forward:

If it is an amendment, has the Intended Use Statement changed from what was originally licensed?

If the Intended Use Statement has changed, does it apply to all of the currently licensed devices on the

license? Does this change require clinical data to back it up? Do

you have it? (We will discuss clinical info and SE Tables later)

Is the new device used in conjunction with other devices?

Does it share a System name? Does it have an overarching Intended Use statement?

Effective Executive Summaries



This tells the MDB reviewer what the submission is about, so make it clear!

In the new electronic submission templates, the Executive Summary comes before the Cover Letter, so it is even more important to make it clear.

Often people write these LAST once the submission is completed

I like to write them FIRST (or at least the skeleton of them)



What to include: Brief description of the device(s)

—Single use? —Sterile? —Size range?—Material?—Used in conjunction with any other devices?

—For an IVDD:- What technology?- What sample type?- What is being detected?- What is it being used for?



Intended Use Statement—As written in the labelling!!

Intended User—Home Use—Healthcare Professional

Purpose of the submission (new vs amendment?)—If an amendment, brief description of the change how it

relates to currently licensed devices.



What to include continued: Brief overview of marketing history

—Is it licensed in Canada, cleared/approved by the FDA, CE marked (since when? Give MDL, 510(k) or PMA #)

—Total number of units that have been sold between x and x dates

—Number of regulatory actions to date (recalls, adverse events)

—Has this device been the subject of an ITA or SAP application? If yes, provide authorization number(s).

Give general information (overview) of what evidence is being provided to support safety and effectiveness

State that Labelling is provided.

Clinical Evidence


Clinical Evidence

Is there clinical data to support all aspects of the intended use?

Do you have direct clinical data on the subject device? If Yes, then provide the clinical report and clinical

protocol if the report does not provide enough details.

If No, is there literature evidence on similar devices that you can use?

Don’t forget to check if there are any published studies with your device that were not conducted by your company!


Clinical Evidence

Have you checked to see if there are any guidance documents (MDB issued or FDA issued)?

If there is any doubt in the adequacy of the clinical data, request to have a pre-submission discussion. Include clinical personnel during discussion with MDB

if available Summarize clinical evidence in the body of the

submission and then include study reports/journal articles/Clinical Evaluation Reports as appendices.


Clinical Evidence

Has a Clinical Evaluation Report been provided in support of clinical evidence? If Yes, are all of the devices included in the CER

directly comparable to the subject device? If No, then pull out the information from the CER

that is pertinent and summarize in the body of the submission.

Are the comparator devices licensed in Canada? Is the comparator device’s intended use in Canada

the same as in other jurisdictions? (i.e. the 510(k) summary has one intended use, but the device in Canada may not have the same intended use.)


Clinical Evidence

Create a substantial equivalence-like table for the subject device and the comparators and discuss in the Design Philosophy section of the submission.

Subject Device Comparator 1 Comparator 2

Manufacturer

MDL #

510(k)/PMA #

IntendedUse/Indications for Use

Materials

Design

Bench Testing (Mechanical Performance)


Clinical Evidence For an IVDD, the table would look a little different

Subject Device Comparator 1 Comparator 2Manufacturer

MDL #

510(k)/PMA #

Intended Use

Technology

Instruments

Sample Type

Sample Prep

Specificity

Precision

Analytical Sensitivity or LOD

Linearity

Target

Tips/Items for Consideration for a Successful Submission to Health Canada


Tips

Follow the electronic submission folder structure that MDB has laidout in their Guidance Document(Health Canada or STED format)

Include a “list of abbreviations”

Do not leave any sections blank. Any section that is not applicable, indicate so with a reason (i.e. Not applicable because….).

Include any pre-submission correspondence (email or phone call summaries)

Make your submission a fluent story


Tips

If the submission is an amendment and this change has not affected certain sections of the submission, it is not sufficient to just say “no change”.

Some sections, repeat the information and just indicate that there has been no change (i.e. intended use, contraindications),

In others, cross-referencing the submission where the original information was provided with Application number and Section should be cited (i.e. Sterilization Validation, biocompatibility testing, performance testing etc.). If not sure where this information was originally cited, then provide again.


Tips

When summarizing test reports include: Purpose Test methods (include any standards that may have

been followed) Acceptance criteria Results Conclusions (did it pass or not)

***Don’t forget, if you are testing a representative device, include worst case scenario rationale.


Tips

Shelf-Life – 3 lots real-time aging data

If more than one test report is provided for the same type of testing, explain why you are providing both. Link them together.

Make your story fluent!!


Tips

If certain testing has not been done that is typical for the subject device, provide a rationale why.

Marketing History Break it out by year and country (ideally go back 5

years unless thousands of device were sold in a shorter period of time)

Include reported events and how any issues were corrected

If new device with no marketing info, provide info on previous generation or similar device.


Tips

Keep a log of Screening Deficiency and Additional Information Requests by device type

The level of scrutiny has increased over the years

Medical device safety issues have an impact on submission content expectations


Tips

If you receive a rejection letter for your licence application, request the reviewer’s notes from MDB. This will help with the re-submission of the

application to ensure that all outstanding issues are addressed

Even if your application is licensed, but there were lots of AI questions, request the reviewer’s notes from MDB. This will help improve your next submission

especially as it will allow you to see where the AI questions were coming from.

Thank You!

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