practical reg approaches-2014 biomedevice

www.PreferredRegulatoryConsulting.com

LESSONS LEARNED - PRACTICAL REGULATORY

APPROACHES

1

Plamena Entcheva-Dimitrov, PhD, RAC Preferred Regulatory Consulting

3 December 2014

www.PreferredRegulatoryConsulting.com 2

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DOS AND DON'TS

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Strategy Stage

Design Stage

Submission Stage


Strategy Stage - Concept! Think of regulatory strategy early - Be clear what

is your intended use and indication for use ! Example 1 - device is filed as a 510(k) and obtains

a clearance, BUT not for the desired indication for use and not even within the same intended use ! Sponsor proposes a clinical study for the desired

indication - agency questions and concerns point to a PMA route, not taking into account the 510(k)

! Result - efforts and resources used for a 510(k), which was not leveraged for the final goal

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Strategy Stage - Concept! Example 2 - a class II delivery system ! Possible indications for use:

! to cure or mitigate a [disease], monitor and or modulate mechanism of treatment: drug mode of action - IND/NDA route

! to deliver a drug, biologic or diagnostic agent: device route with a 510(k) ▫ What if you don't have a predicate - worst case is

de novo ! Result - 17 months from concept to clearance

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Conclusion - Strategy Stage! Think of the regulatory strategy early - this is

not a cliche! ! Assess the risk created by your device as this

plays a role in correctly classifying it ! Be paranoid if you got the classification,

intended use and indications for use right ! Check with multiple regulatory experts ! Investors double-check your regulatory

strategy

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Design Stage! Think of how you will market the device - system vs.

individual components ! Example 1 - implant, software, accessories

! Implant is class III ! Software is imbedded and inseparable from implant ! Accessories can be individually sold as class II or even class I ! If this is a system or a kit, any changes to the accessories are

evaluated at a class III level ! Questions regarding the accessories that may come up during

IDE or PMA review will hold the approval of the class III device

! Result - After initial filing, manufacturer wanted to split off the accessories, but FDA did not agree - delayed IDE approval

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Design Stage! Example 2 - class III implant and accessories

! Accessory 1 is a definite class II with available predicates ! Consider splitting off accessory 1 ! Benefits - can commercialize independently if needed; can make changes

independently of the class III device and the IDE as long as the changes do not impact the study integrity

! Accessory 2 doesn't have a predicate, but still a moderate risk device and could be class II ! If strategy is done early, possibly split off accessory 2 and use a de novo route ! de novo takes longer, so planning is needed early to allow for this

submission ! Benefit is independence from the class III implant for future changes and for

commercialization ! Draw-back is the creation of a new class II device type and a predicate for

competitors ! Result - after initial filing, no design improvements could be implemented to

the accessories until after marketing approval8


Design Stage! Example 3 - a system comprising of capital

equipment and software, disposables and reagents ! All components to the system are class II and have

predicates independent from each other ! Consider filing them all independently ! Benefit - could help with timelines, helps with

future changes to one of the devices ! Draw-backs - manage multiple submissions,

repetitiveness of administrative part of filings; more work for the reviewer

! Result - filed all elements as one 510(k) notification9


Conclusion - Design Stage! Regulatory strategy is an integral component of

the design and development of medical devices ! Evaluate all design decision with eye toward

the regulatory path ! Design decisions could impact the originally

crafted regulatory strategy

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Dos at the submission stage! Follow the most current guidance for your area ! Look at competitors' clearance or approvals recently posted ! Allow time for final formatting, consistency check,

production of the submission and QC your work Use external printing facility - they are worth their money OR rent a spare printer

! Use checklists to show FDA all required elements are in the package

! Double-check your eSubmission copy ! Email your reviewer that the package was sent to the

document mail center

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Don'ts at the submission stage ! Don't rush just to get it in ! Don't allow SMEs to leave on the day of

submission before their sections are closed and sent to print

! Don't send a submission if you know it's deficient - your reputation with the regulator is priceless ! If you have to send a deficient submission, lay

out the risks to management and get agreement ! Have a plan to fill-in the gaps and start working

on it as soon as practicable 12


Conclusion - Submission Stage! Don't rush at the end ! Attention to detail is crucial ! Take measured risks that are pre-approved by

management ! Make the work of your regulator counterpart as

easy as possible

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Free Advice - Dos! Do use FDA's website as a free resource

! Device Advice ! On-line training/webinars on new guidances ! Tune into FDA's public meetings

! Notified Bodies Training ! Consulting Firms Training and Newsletters

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Free Advice - Don'ts! RA blogs and social media are great, but free

advice may or may not exactly apply to your specific situation

! Don’t ask you sister's friend who worked in a design firm 10 years ago just because she is a nice person and will give you a free advice

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Final Thoughts! Look at your RA strategy as a value-adding asset ! The ultimate validation of your RA strategy is meeting with FDA -

use the Pre-Sub process to your advantage - it's free of charge ! There is always more than one way of doing things - use risk-based

approach in developing it ! Balance regulatory risks with business risks

! Re-evaluate your strategy ! New or changing legislation, regulations, guidances, standards ! New approvals or clearances can impact your design decisions ! Recall / warning letter of a competitor ! Industry-wide trends

! If not done right at the get go, it can cause design confusion ! Damaged relationship with regulators ! DELAYS = $$$

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THANK YOU!

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Plamena Entcheva-Dimitrov, PhD, RAC

[email protected]

mailto:[email protected]


QUESTIONS?

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Please email us at [email protected]

mailto:[email protected]

practical reg approaches-2014 biomedevice

Documents

regulatory strategy

strategy stage concept

conclusion strategy

device route

definite class

intended use

device system

use right