CE Marking , FDA Approval and Associated Regulations for Wellness

CE Marking, FDA Approval and Regulations for Wellness 11 January 2011 www.wellnesshealthinnovation.orgICS Confidential

Overview Managing the Device Regulatory Approval Process for Multiple Countries An Overview of Key Elements of EU/US and Worldwide Regulatory Strategies and How to Align them with other Business Strategies

Questions you may have!! Is my product a Medical Device? If so, what is its classification? How do I show it complies with the Essential Requirements? How do I construct a Technical File? What must I do to meet the risk management requirements? Does compliance with international/national standards help? How do I prepare a clinical evaluation report?

Questions you may have!! Do I need a Notified Body? If so, how do I select one? Do I need a certified quality management system? Does my device labelling meet the requirements? What do I need to do if I assemble procedure packs? What should be included on my Declaration of Conformity? What are my post-market reporting obligations?

Similarities/Differences Global Regulatory Approaches 5 Go to Regulatory Body Class (Risk Based) Market Approval Quality System Adverse Event Reporting United States (U.S.) FDA Center for Devices and Radiological Health Class 1, 2, 3 Exempt Clearance Approval letter QS Regulations 21 CFR 820 MDR Canada Health Canada Class I, II, III, IV MD License except Class I CAN/CSA ISO 13485 Vigilance System EU (European Union) Competent Authority Notified Body Class I, IIa, IIb, III CE Marking MDD/IVDD EN ISO 13485 Vigilance System Japan Ministry of Health, Labour and Welfare Class 1, 2, 3, 4 MHLW Approval certificate QMS Ordinance ISO 13485 Vigilance System Australia Therapeutic Goods Administration Similar to EU. Similar to EU ISO 13485 Vigilance System

Background Information Regulatory Applications for Devices United States 510(k) – Substantial Equivalence w/ Predicate(s) Intended Use / Indications for Use Similar Technology Assumed Safety and Effectiveness PMA – Proves Safety and Effectiveness No Predicate Requires Animal and Human Trials DeNovo – Risk Based Classification 510(k) – NSE + DeNovo Application Requires Special Controls Guidance Document Others 513(g) – Request for Classification RFD – Request for Designation (combination products) IDE – Investigational Device Exemption CONFIDENTIAL Page 6

Background Information Europe CE Marking Product Approval MDD Compliance (Essential Requirements) Technical File / Technical Dossier QMS Approval ISO 13485 Notified Body Audit Canada License Application QMS Certification ISO 13485:2003 Canadian Registrar Additional CMDCAS Requirements Others Nearly all 1 st and 2 nd World Countries have requirements for marketing medical devices CONFIDENTIAL Page 7

US vs. the E.U. and Canada Similarities Risk Based Device Categorization Schemas US – Class I to Class III EU – Class I, Class IIa, Class IIb, Class III Canada – Class I to Class IV Premarket Clearance / Approval Required Amount / Type of Data Submitted is Based on Risk Clinical Data Required for High Risk Devices Quality Management System Required cGMP and ISO 13485:2003 are very similar Post Market Monitoring and Adverse Event Filing Required Audits are performed to verify compliance Clinical Trials Required Pre-Approval US – IRB + IDE for Significant Risk, IRB only for Non-Significant Risk EU – Ethics Board + Competent Authority for non-CE devices, Ethics Board only for CE devices Canada – Ethics Board + ITA for Class II – Class IV devices, Ethics Board only for Class I devices CONFIDENTIAL Page 8

US vs. the E.U. and Canada Differences Risk Based Device Categorization Schemas Canada and EU use “Rules Based” approach, not lists of devices and associated classifications (pro-codes) Dramatic Differences in resulting Device Classifications (i.e. – US Class III could be EU Class I) Premarket Clearance / Approval Required Canada and EU have a single, scalable application type vs. US with two distinct dissimilar applications (tech file vs. 510(k) and PMA) Canadian Review done by Governmental Agency EU Review done by Third Party (Notified Body) or Self Declaration US Review done by both FDA and Third Parties CONFIDENTIAL Page 9

US vs. the E.U. and Canada Differences Quality Management System Required cGMP and ISO 13485:2003 are very similar Post Market Monitoring and Adverse Event Filing Required Audits are performed to verify compliance Clinical Trials EU - All Devices Required Clinical Data Report (Annex X) Allows a combination of Literature Review, Clinical Information, and Clinical Data Class IIb and Class III require Clinical Data Canada – Class III and Class IV typically require clinical data US – Class III PMA Devices require Clinical Data. Some 510(k) devices require clinical data to support Substantial Equivalence. CONFIDENTIAL Page 10

Key Differences What Differences Are Most Important Classification – Determines Application and Clinical Data Requirements Quality Management System Timing Requirements QMS must be IMPLEMENTED and AUDITED to obtain CE Only selected cGMP elements must be implemented to submit 510(k) PMA products require Pre-Approval cGMP audit ISO / CMDR Assessments vs. cGMP Audits ISO – Audits performed by Notified Body you select and pay CMDR – Audits performed by Canadian Registrar you select and pay cGMP – Performed by Regulatory Authority Canada / EU – Supportive approach assuming compliance FDA – Punitive approach assuming non-compliance CONFIDENTIAL Page 11

Other Things To Remember US Not all Class I Devices are exempt from any or all of the following: Design Controls Specific Class I device require application of Design Controls cGMP Even cGMP exempt have to comply with Complaint and Records Requirements 510(k) EU EU Device Classification to determine Routes to Market (Annex combinations from MDD) Nearly always more than 1 route ISO 13485 is not called out by MDD It is possible to need FULL 13485 compliance for other countries but not for EU. Sales / Marketing plan is important to a good strategy CONFIDENTIAL Page 12

With so many regulations out there…… where do you start?

Regulatory Strategy Overview What Is A Regulatory Strategy? A Path for Regulatory Clearance / Approval in a Market Understanding of the Requirements to Obtain Clearance or Approval Application Type Requirements for Bench Testing Requirements for Animal Testing Requirements for Human Testing Quality Management System Requirements Quality Management System Certifications Understanding the Sequence of Events and Timing Understanding the Integration of Business and Regulatory Activities Understanding of Expected Regulatory / QMS Costs CONFIDENTIAL Page 14

Regulatory Strategy Overview Why Is It Important? Cost Nearly always more than one available strategy Wide variation in cost based on application type 510(k) - $20K to $2M PMA - $500K – $10M Time-To-Market 510(k) – Prep Time + 90 day review (real world 180 days) PMA – Prep Time + 180 day review (real world 2+ years) Raising Capital Regulatory Strategy now required for many types of financing Due diligence often includes Regulatory Strategy review Organizational Structure and Hiring What QA / RA resources will be necessary to achieve strategy Legal Ramifications of Non-Compliance Warning Letters, Consent Decrees, Cessation Orders, Import Bans, etc. CONFIDENTIAL Page 15

Regulatory Strategy Overview How Do I Know If My Current Strategy Is Good Enough? Your Strategy Should Answer All Of The Following: Where will the product be distributed in the first 36 months after launch? What Regulatory Applications will be required in each country? Which applications require clinical or animal data? If Clinical Data is required, where will trials be conducted and what applications / approvals are required for the clinical trial? How long is the average review time for my application type and product type in each country? Are there fees associated with the Regulatory Application? For each application, what is the likelihood of approval / clearance and what are the risk areas? Do any of the applications require corresponding QMS inspections / certifications (pre-approval inspection, ISO certification, etc.)? Do Design Controls apply to my product and if so, how will I meet these requirements? Where the finished product will be manufactured CONFIDENTIAL Page 16

Common Mistakes / Misconceptions General No Written Regulatory Strategy Failure to Follow Design Controls / Start Design Controls Too Late Regulatory Requirements are Black and White United States My product will be cleared through a 510(k) Clinical and Animal Trials are required for all US Applications There is no middle ground between 510(k) and PMA The 510(k) process today is the same as 1 year ago Internationally CE is Easy If I get a 510(k) or PMA, I can ship my product anywhere in the world Clinical Trials can be conducted without rules outside the US CONFIDENTIAL Page 17

Outsourced design and mfg If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of their quality system. © 2005 Emergo Group, Inc. Australia > Canada > The Netherlands > United States 1.800.956.6588

Software Will now be considered an active medical device, whether integral with the device or as a standalone product. Software validation will also be an Essential Requirement. © 2005 Emergo Group, Inc. Australia > Canada > The Netherlands > United States 1.800.956.6588

Consider Regulatory Issues Early On It is easily understood that new companies developing innovative technologies to solve clinical problems concentrate their thoughts on optimizing the technology for the intended use, and keeping the company afloat financially. Unfortunately, unless issues relating to regulatory compliance are also considered early on, this can lead to problems closer to the time when the product is ready for marketing. This may result in delays, sometime substantial, in having the product available for sale, with knock‐on effects in meeting critical investment milestones, and even to the survival of the company itself. The company's initial business plan should include an outline regulatory strategy that is closely aligned to the marketing strategy (indeed, the regulatory strategy may often drive the marketing strategy).

Reminders to take home..... When planning to expand your empire, investigate what is required for each country and budget as appropriate. Understand the process Do Not Make Assumptions Choose the correct partner/distributor You don’t want to repeat the process, Take the time to choose wisely. Plan your Timelines Give yourself plenty of time Country Approval is not CHEAP

Medical Device Myth’s “ My marketing strategy will drive my regulatory strategy.” “ I’m just a one‐person start‐up – I don’t need Regulatory support yet.” “ I’ve made a prototype, so now I can give it to a clinician to try it out.” “ I’ve read the regulations. I don’t need to do all that, do I?” CEO/MD or Board of Directors “ I don’t need to understand about QA/RA. I’ve got a QA/RA manager to do that.” Making the wrong strategic decisions early on, based on bad regulatory understanding or advice, can lead companies into "blind alleys," hindering their ability to meet investor milestones and raise additional funds.

Thank You and Questions? Edwin Lindsay [email_address]

CE Marking , FDA Approval and Associated Regulations for Wellness

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CE Marking , FDA Approval and Associated Regulations for Wellness