Practical Reg Approaches-2014 Biomedevice

Practical Reg Approaches-2014 Biomedevice

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  www.PreferredRegulatoryConsulting.com LESSONS LEARNED - PRACTICALREGULATORY APPROACHES 1 Plamena Entcheva-Dimitrov, PhD, RAC Preferred Regulatory Consulting 3 December 2014
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  www.PreferredRegulatoryConsulting.com 2 Legal Disclaimer ThePreferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright laws.
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  www.PreferredRegulatoryConsulting.com DOS AND DON'TS 3 Strategy Stage Design Stage Submission Stage
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  www.PreferredRegulatoryConsulting.com 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 4
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  www.PreferredRegulatoryConsulting.com 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 5
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  www.PreferredRegulatoryConsulting.com Conclusion - StrategyStage ! 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 6
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  www.PreferredRegulatoryConsulting.com Design Stage ! Thinkof 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 7
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  www.PreferredRegulatoryConsulting.com Design Stage ! Example2 - 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 approval 8
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  www.PreferredRegulatoryConsulting.com Design Stage ! Example3 - 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) notification 9
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  www.PreferredRegulatoryConsulting.com Conclusion - DesignStage ! 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 10
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  www.PreferredRegulatoryConsulting.com Dos at thesubmission 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 11
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  www.PreferredRegulatoryConsulting.com Don'ts at thesubmission 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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  www.PreferredRegulatoryConsulting.com Conclusion - SubmissionStage ! 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 13
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  www.PreferredRegulatoryConsulting.com 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 14
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  www.PreferredRegulatoryConsulting.com 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 15
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  www.PreferredRegulatoryConsulting.com Final Thoughts ! Lookat 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 = $$$ 16
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  www.PreferredRegulatoryConsulting.com THANK YOU! 18 Plamena Entcheva-Dimitrov,PhD, RAC [email protected]
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  www.PreferredRegulatoryConsulting.com QUESTIONS? 19 Please email usat [email protected]