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www.PreferredRegulatoryConsulting.com
LESSONS LEARNED - PRACTICAL REGULATORY
APPROACHES
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Plamena Entcheva-Dimitrov, PhD, RAC Preferred Regulatory Consulting
3 December 2014
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Legal Disclaimer
The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright laws.
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DOS AND DON'TS
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Strategy Stage
Design Stage
Submission Stage
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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
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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
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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
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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
entcheva@PreferredRegulatoryConsulting.com
www.PreferredRegulatoryConsulting.com
QUESTIONS?
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Please email us at info@PreferredRegulatoryConsulting.com
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