Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 2013)

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Latest update USA Regulations By P.Trisler Qserve Group (Qserve Conference 2013)

  1. 1. The regulatory road to market US FDA Regulations - Overview & Update Qserve Conference 18-19 November 2013 Purmerend – Greater Amsterdam Page 1 | 2011 |Copyright Qserve Group B.V.
  2. 2. Topics • Overview of FDA, Medical Device Classification System & Regulatory Processes • New Processes Impacting Many Programs   • Refuse to Accept (RTA) Electronic Copy (eCopy) Changes related to Submissions  De Novo Application   • Pre-De Novo Submission (PDS) Pre-Submission (Pre-Sub) Miscellaneous  Unique Device Identification (ID)  International Symbols  Medical Device Single Audit Program Pilot (MDSAP) Page 2 | 2013 |Copyright Qserve Group B.V.
  3. 3. Topics Additional New FDA Guidances – Clinical • Design Considerations for Pivotal Clinical Investigations for Medical Devices -Guidance for Industry, Clinical Investigators, IRBs & FDA Staff (Nov, 2013) • Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies (Oct 2013) • Oversight of Clinical Investigations – a Risk-Based Approach to Monitoring (Aug 2013) • (Draft) FDA Decisions for IDE Investigations (June 2013) • Financial Disclosure by Clinical Investigators (Feb 2013) Page 3 | 2013 |Copyright Qserve Group B.V.
  4. 4. Overview FDA ….some facts…  Headed by a Commissioner (Margaret Hamburg, MD) appointed by US President  Headquartered in Washington, D.C – CDRH, CDER, CBER, CVM, etc  21 District Offices around the U.S.  Regulates > $1 trillion of products  Has regulatory authority over >65,000 establishments (not including entities under BIMO – labs & clinical research sites)  Employs > 9,000 staff Page 4 | 2013 |Copyright Qserve Group B.V.
  5. 5. US President Health & Human Services Food and Drug Administration CDRH ODE CDER CBER ORA OC Div of BIMO Page 5 | 2013 |Copyright Qserve Group B.V.
  6. 6. Overview – FDA’s Authority & Governance  US Congress: Federal Food, Drug & Cosmetic Act (1938), as amended…  The ‘device law’ (1976) -- Medical Device Amendments  Several amendments passed since that time  US Federal Agencies/FDA: Regulations  FDA Centers/Offices: Guidances/Guidelines/Points to Consider Page 6 | 2013 |Copyright Qserve Group B.V.
  7. 7. Overview – US Federal Regulations Title 21 Code of Federal Regulations (CFR) Parts 1 – 99 General – for enforcement of the FD&C Act Parts 800 – 1299 Medical Devices & Radiological Health Page 7 | 2013 |Copyright Qserve Group B.V.
  8. 8. Overview – Regulations (21 CFR…)  Part 3 – Combination Products  Part 803 – Medical Device Reporting  Part 11 – Electronic Records  Part 807 – Premarket Notification/510(k),  Part 50 – Subject Protections  Part 54 – Financial Disclosure  Part 56 – IRB  Part 801, 809 – Labeling Establishment Registration & Listing  Part 812 – IDE  Part 814 – HDE, PMA  Part 820 - QSR (GMP) Page 8 | 2013 |Copyright Qserve Group B.V.
  9. 9. Overview – CDRH search engines General – http://www.fda.gov/MedicalDevices/default.htm Database Search page http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm Page 9 | 2013 |Copyright Qserve Group B.V.
  10. 10. Overview • Classification System  Class I, II & III (1700 devices pre-assigned in 1976) 799 Class I Class II 119 Class III 782 Page 10 | 2013 |Copyright Qserve Group B.V.
  11. 11. Overview • Classified by perceived/known risk & regulated accordingly General Controls Class I ✔ Class III ✔ Premarket Approval ✔ Class II Special Controls ✔ ✔ Page 11 | 2013 |Copyright Qserve Group B.V.
  12. 12. Overview – General Controls 1. Establishment Registration with FDA 2. Medical Device Listing with FDA 3. Manufacture devices according to QSR/GMP in 21 CFR Part 820. 4. Label devices in accordance with labeling regulations in 21 CFR Part 801 or 809. 5. Submit a Premarket Notification [510(k)] before marketing a device. Page 12 | 2013 |Copyright Qserve Group B.V.
  13. 13. Overview – Special Controls Examples  Special labeling requirements  Mandatory performance standards  Postmarket surveillance  Special Controls Guidance Document Page 13 | 2013 |Copyright Qserve Group B.V.
  14. 14. Overview – Paths to the Market Application Type Comments Regulatory Review Product Classes 510(k) = Premarket Notification Substantially equivalent (“at least as safe & effective as a legally marketed/predicate device”) 90 days Class II generally 510(k)/de novo Petition Low to moderate risk; novel device. 510(k) must conclude NSE bec no predicate device. Product has to be shown to be safe & effective. ?? Class I/II PMA = Premarket Approval Reasonable assurance of safety & effectiveness based on valid scientific evidence 180 days Class III HDE = Humanitarian Device Exemption For humanitarian use device (<4000 persons in US/year). Evidence of safety and probable benefit. Requires IRB approval for each use. ~75 HDEs approved by FDA 75 days Class III Page 14 | 2013 |Copyright Qserve Group B.V.
  15. 15. Overview – Device User Fees (2013-14) Application Type Standard US $ *Small Business Premarket Approval Application (PMA/PDP/BLA) $258,520 $64,630 1st PMA from firm w/ sales/gross receipts < $30 mil n/a $0 513(g) Classification Request $3,490 $1,745 510(k) Premarket Notification $5,170 $2,585 Annual Registration $3,313 $3,313 *Small business = <$100M in gross receipts/ sales Page 15 | 2013 |Copyright Qserve Group B.V.
  16. 16. New Processes • Refuse to Accept Policy for 510(k)s – RTA  • 31 Dec 2012 eCopy Program for Medical Device Submissions  10 Oct 2013 Page 16 | 2013 |Copyright Qserve Group B.V.
  17. 17. New – RTA Key Points  Purpose: Administrative Review  To assure complete submissions - question of ‘completeness’ (administrative) and not ‘quality of data’ (substantive).  FDA checklist  Provides specific information point-by-point of the elements/contents that are considered ‘incomplete’.  15 calendar day post-submission review period  90-day substantive review clock starts on a determination of ‘completeness’. Date will be the log-in date if no issues.  If there are issues & the RTA checklist is sent to applicant, the 90-day review clock will not start until those have been resolved. Page 17 | 2013 |Copyright Qserve Group B.V.
  18. 18. New – eCopy • (1) Definition: Exact duplicate of paper copy, created and submitted on a CD, DVD or flash drive. It is not a submission transmitted electronically.  • Some exceptions regarding ‘exact duplicate’ Required for:  510(k)  PMA, traditional and modular  De Novo  PDP  IDE, with certain exceptions (compassionate use & emergency use) Page 18 | 2013 |Copyright Qserve Group B.V.
  19. 19. New – eCopy • (2) Requirements: Technical standards for loading the file must be met (no exceptions) Particularly important:  Naming convention (‘correct’ prefix: “001_”) » Follow instructions closely with more than 1 volume  Files must be 50MB or smaller  Adobe Acrobat PDF Ver 11 or below  No embedded attachments  No security settings  Beware of special characters Page 19 | 2013 |Copyright Qserve Group B.V.
  20. 20. New – eCopy (3)  Consequences of incorrectly prepared eCopy: Submission will not be accepted and the date of receipt will not be the ‘log-in’ date.  However, FDA will hold the paper copy until a correctly-created replacement eCopy has been received & loaded. Page 20 | 2013 |Copyright Qserve Group B.V.
  21. 21. Submission Changes/Updates • De Novo Classification Process (Evaluation of Automatic Class III Designation): Draft Guidance, 3 Oct 2011 (to replace a 1998 guidance) • Medical Devices: The Pre-Submission Program and Meetings with FDA Staff: Draft Guidance 13 July 2012 (includes Pre-IDE Program) Page 21 | 2013 |Copyright Qserve Group B.V.
  22. 22. Changes – De Novo Process • (1) Authorization: 513(f)(2) of US Federal Food, Drug & Cosmetic Act (FD&C Act) – passed in 1997, FDA Modernization Act (FDAMA) • Prior to 1997 all new devices, regardless of risk level, would have been classified in Class III and require PMA. • • De Novo = “Evaluation of Automatic Class III Designation” Requirements for qualifying for de novo:  Low to moderate risk medical device  Novel (no predicate device/not previously classified)  NSE (not substantially equivalent) determination by FDA via 510(k), e.g ‘auto classification into Class III’  File De Novo Petition Page 22 | 2013 |Copyright Qserve Group B.V.
  23. 23. Changes – De Novo Process • (2) Additional requirements to a successful petition  Risks & benefits need to be understood  ‘Controls’ need to be possible to provide reasonable assurance of safety & effectiveness of the device ‘type’  • Those controls often include the conduct of clinical studies. Good news if the new guidance is fully implemented: It provides for greater clarity & transparency, in particular:  Pre de novo submission (PDS) >> 510(k)/De Novo Petition, vs the ‘standard’:  510(k) >> De Novo Petition 90 de novo petitions granted to date. Page 23 | 2013 |Copyright Qserve Group B.V.
  24. 24. Changes – Pre-Sub (Encompasses Pre-IDE) • Process that formalizes obtaining FDA’s pre-review for:  Non-clinical (laboratory & animal) protocol  Clinical protocol/design issues, prior to submitting an IDE  Pre-marketing submission interactions on a variety of topics (such as uncertainty in method of presenting data, changes in device during IDE study, discussion of problems encountered during conduct of clin study) • Specified format & content requirements • Timeline = 75-90 days • Feedback via teleconference, face-to-face meeting or written (always receive written comments) Page 24 | 2013 |Copyright Qserve Group B.V.
  25. 25. New – Unique Device Identifier (UDI) System Implementation of US FD&C Act §519(f) (Sept, 2013). Two key elements: (1) Requires a UDI on devices & device packages (w/ some exceptions)  Must be marked on the device itself if the device is intended for use more than once & intended for reprocessing before each use. (2) Device labelers – info for each device labeled with UDI to FDA’s Global UDI Database (GUDID).  Plain-text version & in a form that uses automatic ID & data capture tech.  All required device records must include the UDI.  7-year phase-in period (depending on risk level). Page 25 | 2013 |Copyright Qserve Group B.V.
  26. 26. New – International Symbols • Currently – Medical Device Labeling (except for IVD) must accompany international symbols with ‘words’. • Under consideration (proposed Rule) – Option on part of medical device manufacturers to use standardized international symbols (recognized by FDA) on labeling. Page 26 | 2013 |Copyright Qserve Group B.V.
  27. 27. New – Medical Device Single Audit Program Pilot • Mission: Single audit program for medical device manufacturers • Sponsored by International Medical Device Regulators Forum (IMDRF) • January 2014 - FDA will begin participating in a MDSAP Pilot alongside other international partner agencies: • • • Partners: Australia, Brazil, Canada Observer: Japan Pilot (Jan 2014 – Dec 2016) – auditing organizations: only those utilized by Health Canada’s CMDCAS Program. • MDSAP for FDA: • routine inspections only • no ‘for cause’, no PMA (pre- or post-approval) Page 27 | 2013 |Copyright Qserve Group B.V.
  28. 28. Thank you! P a t s y Tr i s l e r Qserve Group US Inc. P a t s y. t r i s l e r @ q s e r v e g r o u p . c o m www.qservegroup.com Qserve Group B.V. Asterweg 19 D12 1031 DL Amsterdam The Netherlands T +31 (0)20 78 82 630 E info@qservegroup.com Page 28 | 2013 |Copyright Qserve Group B.V.

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