How to Manage Regulatory Issues and get FDA Approvals

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1 How to Manage Regulatory Issues and get FDA Approvals Maureen Garner, President Glenn Neuman, Director of Scientific Affairs New World Regulatory Solutions, Inc. 1

2 About NWRS New World Regulatory Solutions, Inc. (NWRS) was founded in 2002 with the mission of helping domestic and international companies gain regulatory approval for innovative medical devices. 2

3 What % of Medical Devices sold in the US are manufactured off-shore? 50%! Is yours one of them? 3

4 US FDA is the Gatekeeper to the US Medical Device Market Company Team MANAGEMENT REGULATORY US FDA QUALITY MARKETING R & D 4

5 Good Regulatory Practices Lead to FDA Clearance MANAGEMENT REGULATORY QUALITY SYSTEMS MARKETING R & D US FDA Strategy, compliance and know-how are critical! 5

6 Overseas Manufacturers US Partner USA 6

7 Regulatory Submissions to US FDA FAQs about FDA Submissions What % of submissions require clinical data? 10% Can clinical data from foreign studies be used? Yes, provided that: Similar practice of medicine Similar protocols Ethics approval Sample availability issues 7

8 Regulatory Submissions to US FDA FAQs about FDA Submissions Does conformance with International Consensus Standards help? Yes FDA has a list of recognized standards Basis for Abbreviated 510(k) Must submit FDA Form 3654 for each recognized standard cited 8

9 Regulatory Submissions to US FDA FAQs about FDA Submissions How similar are the FDA quality system requirements and ISO 13485? Pretty Close! ISO-compliant companies need only a few Quality System adjustments to meet FDA regulation 9

10 Regulatory Submissions to US FDA FAQs about FDA Submissions FDA refers to a least burdensome approach what is that? Good question! We find that it s a case-by-case negotiation, often with frustrating outcomes. Will FDA review requirements get more stringent? Yes! Upcoming public meeting on February 18 But so is the EU /47/EC amendment to MDD FDA Approvals are based on two key issues: 1. Good Science 2. Public Health Safety 10

11 New MDD Requirements (2007/47/EC) Clinical evaluation required in Technical File Actively updated; post-market surveillance Clinical investigation can be required CNS surgical devices: Class IIa Class III Class IIa disinfecting devices Class IIb Software becomes a stand alone medical device Classification via Primary Mode of Action, not Intended Use New labeling requirements for high-risk devices March 21,

12 Regulatory Submissions to US FDA Review occurs in one or more FDA Centers FDA CDRH CBER CDER OCP Devices, IVDs Biologicals, Blood Banking Drugs Combination Products HIV diagnostics 12

13 Regulatory Submissions to US FDA FDA conducts either: Pre-Market Review, known as a 510(k) New product is substantially equivalent to existing legally marketed product Product is cleared for market through a 510(k) Notification Pre-Market Approval, known as a PMA New product is tested directly against a clinical reference to demonstrate safety and efficacy Product is approved for market Which route should you choose? 13

14 Device Submissions to US FDA Type of FDA submission required depends on Device Classification Device Classification depends on Risk Class 1 Class 2 Class 3 - lowest risk, most are exempt*: - moderate risk, some exempt*, remainder are 510(k) - highest risk, mostly PMA, some (<50) 510(k) * Exempt does not apply for point of care, automated or home use. 14

15 Device Submissions to US FDA Are FDA Classes the same as CE classes? No FDA classes are based on RISK and INTENDED USE CE classes are based on PRIMARY MODE OF ACTION But, there is plenty of similarity when these methods are applied 15

16 Device Submissions to US FDA Types of FDA Submissions 510(k) Premarket Notification ~3,500/year, >95% approved Clinical performance data needed for IVDs, but some can be done in-house. PMA Premarket Approval ~35 submissions/year, ~80% approved Most stringent -- Clinical safety and effectiveness data required 16

17 Device Submissions to US FDA 510(k) Demonstrates substantial equivalence with predicate Traditional -- new device Abbreviated -- conformance to guidance, special control, or recognized standard Special -- minor changes to device or reagents or sample treatment with review of design control De Novo -- lower risk device with no predicate 17

18 Device Submissions to US FDA Types of FDA Submissions CLIA Waiver IVDs only, Market Access > 170,000 POC sites in US Must be simple, fool-proof: So easy even a doctor can do it! 11 Submission in 2008, 5 approved 6 Submissions in 2009, 1 approved New FDA Guidance -- harder than 510(k)s The test has to be easy, but the approval is not! 18

19 Device Submissions to US FDA How Long Does It Take (excluding studies)? PMA FDA FDA review time goal is 180 days Average Real Days = ~ one year 510(k) FDA review time goal is 90 days Average Real Days = ~ 100 (Traditional) IVDs take longer (statistical review of performance data) CLIA Waiver no official Goal Real Days for 5 approvals in Real Days for 6 denials in

20 100 % 90 % 80 % Realistic 510(k) Time Scenario Product Cleared Post- Market Activities % Project Completion 70 % 60 % 50 % 40 % 30 % 20 % 10 % 0 % Initiation Submit Pre-IDE Pre-IDE Approved Conduct Clinical Studies FDA Review Submit 510(k) Conduct Non-Clinical Studies Negotiations Time, Months 20

21 Device Submissions to US FDA How Much Does It Cost? PMA Most expensive FDA Application fee $0 for first if under $30MM $50,181 < $100MM $200,000 > $100MM Clinical Costs $1MM for IVD, can be less for Devices Non-clinical studies $1-2MM Total Costs (Rule of Thumb) 21

22 Device Submissions to US FDA How Much Does It Cost? 510(k) FDA Application Fee $1,847 < $100MM $3,693 > $100MM Total Costs are Extremely Varied Depends on Device Depends on type of 510(k) $20,000 - $250,000 Total Costs Clinical Studies increase costs 22

23 Device Submissions to US FDA How Much Does It Cost? CLIA Waiver (IVDs Only) No FDA Application Fee Clinical Intended User Data are required 240 or 360 prospective patients Comparison to reference method $80,000 - $120,000 Total Costs 23

24 Does FDA help? Where to Begin Guidance Documents 513(g) Request classification Pre-IDE FDA informal review of study plan IDE (Devices or reporting IVD results) DSMICA Meetings phone or face-to-face, can be binding or non-binding Quality System Regulations ( GMPs ) 24

25 Quality Systems Regulations Manufacturers must conform with GMPs GMPs -- Devices and IVDs 21CFR820 Same for Devices and IVDs cgmps -- Drugs 21CFR211 Similar to ISO GLPs and GCPs also required 25

26 Device Submissions to US FDA AVOID COSTLY MISTAKES Submission poorly written Lack of statistical support Studies not designed to support claims Poor oversight of clinical studies Product not designed for target market High, Moderate and Waived complexity Human factors not considered Quality Systems not compliant 26

27 Labeling and Instructions Labeling and Instructions must follow regulations and guidelines Special considerations for CLIA Waiver and Home Use Marketing materials and website are considered labeling 27

28 Quality System Inspections by US FDA Occur BEFORE your PMA Approval Study sites, investigator files Manufacturing facilities Company Quality System Occur AFTER your 510(k) Clearance Manufacturing facilities Company Quality System Will occur, FDA priorities and resources dictate schedule 28

29 Regulatory Strategy in Business Plans Phase 1 Phase 2 Phase 3 Phase 4 Strategic Development Target Market Intended Use Protocols Study Forms Draft Labeling Pre-IDE FDA Meeting Project Initiation Qualify/Contract Study Sites Ethics Approval Train/Initiate Sites Non-Clinical Studies Execute Studies Monitor Sites Collect/Compile Data Close Sites Prepare Reports FDA Submission and Clearance Prepare Submission Follow-up with FDA Finalize Labeling FDA Approval PRODUCT LAUNCH Seed Money Milestone payment Milestone payment Milestone payment ROI 29

30 Good Regulatory Strategy Ensures Success Market Goals Regulatory Strategy Product Design Funding Milestones 30

31 Thank you! Looking forward to seeing YOUR product in the US! Maureen Garner, President Glenn Neuman, Director of Scientific Affairs New World Regulatory Solutions, Inc (Glenn) (Maureen) 31

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