FDA 510(k) 101 The Basics

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1 FDA 510(k) 101 The Basics Floyd G. Larson President, PaxMed International San Diego, CA OMTEC June 17, 2010 Chicago Agenda History of 510(k) process FDA s risk based approach FDA guidance and standards Structure of a 510(k) Submission to FDA Follow up with FDA History of 510(k) Program Began May 28, 1976 Medical device amendments to Federal Food Drug & Cosmetic Act ( the Act ) Section 510(k) of the Act Initial regulation of medical devices Grandfathered devices already on market, if risk low (Class I or II) Pre amendments devices New devices cleared if substantially equivalent to devices on market prior to May 28, 1976 Now can be SE to devices that are SE 1

2 Section 510(k) of the Act (k) Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for

2 2 Section 510(k) of the Act (k) Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary or person who is accredited under section 523(a) (in such form and manner as the Secretary shall by regulation prescribe) (1) the class in which hthe device is classified under section 513 or if such person determines that the device is not classified under such section, a statement of that determination and the basis for such person's determination that the device is or is not so classified, and (2) action taken by such person to comply with requirements under section 514 [performance standards] or 515 [premarket approval] which are applicable to the device.... Premarket Notification Original 510(k) process involved sending FDA a letter indicating intent to introduce new device into interstate commerce If no response within 90 days, OK to sell Soon changed to require that a favorable letter from FDA be received prior to marketing Review process now much more rigorous Mini PMA An early 510(k)

3 3 Here it is all 6 pages The beginning of the content This is all there is!

4 How are things different now? 510(k)s may have pages (or more) Solid predicate device(s) are essential Need carefully considered Indications for Use Need strong supporting data Performance testing bench Performance testing animal Performance testing clinical A growing number of submissions Need strong Substantial Equivalence argument Risk based Classification Three Regulatory Classes (level of control based on risk): Class I General Controls (most exempt from 510(k)) Class II General Controls & Special Controls (Guidance Documents, Standards) Class III General Controls & Premarket Approval What is Class III? FDA has determined that Special Controls are not sufficient to ensure safety and effectiveness Class III devices generally are not eligible for 510(k) clearance (need Premarket Approval) Exception for Preamendments Class III devices for which FDA has not yet issued a call for Premarket Approval applications 4

5 Devices Exempt from 510(k) Preamendments devices Unfinished devices Devices exempt by statute or by regulation 739 Class I, 74 Class II Finished devices not sold in U.S. Devices covered under another 510(k) Private labeled devices Custom devices Veterinary devices Is a 510(k) needed? Is it a Medical Device? Is it exempt from 510(k) requirement? Note that it probably is subject to QSR 21CFR 820 Is it a PMA device? Types of 510(k)s Class II and Preamendments Class III Traditional 90 day review Special Rli Relies on Design Controls 30 day review Abbreviated Relies on conformance to standards 5

6 Special 510(k) Used to obtain clearance for a change to a manufacturers own device Same Indication for Use Based on conformance to Design Controls (21CFR ) Submission not easier than Traditional Review time 30 days See FDA guidance at Abbreviated 510(k) Based on conformance to standards and/or FDA guidance documents No advantage for review timing Not commonly used Standards are also used in Traditional 510(k)s Role of Standards Voluntary Organizations such as ASTM, ISO Voting process ASTM by company or individual, ISO by country Recognized by FDA (see FDA recognition list) search.cfm Even when they are not performance standards, they are useful in aiding comparison to historical data or predicate devices 6

7 Substantial Equivalence A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and has the same technological characteristics as the predicate; or has the same intended use as the predicate; and has different technological characteristics and the information submitted to FDA; does not raise new questions of safety and effectiveness; and demonstrates that the device is at least as safe and effective as the legally marketed device. 510(k) Review Flowchart 510(k) Review Flowchart 7

8 8 Reviewer Template for 510(k) Reviewer Template for 510(k) Reviewer Template for 510(k)

9 9 Reviewer Template for 510(k) Reviewer Template for 510(k) Reviewer Template for 510(k)

10 10 What does the 510(k) process accomplish (and what not)? Outcome of 510(k) review determines classification of a device If Substantially Equivalent ( SE ) SE) takes classification of predicate If Not Substantially Equivalent ( NSE ), device is Class III 510(k) clearance is not approval That requires the Premarket Approval (PMA) process A 510(k) is not registration or device listing Nuts andbolts Beginning the Submission Define intended use of device Search for FDA guidance documents FDA database of guidance documents Determine classification FDA database of product codes Look at product codes of similar devices (510(k) summaries) Read classification regulation Search for predicate device candidates Same intended use and product code Similar technological characteristics Multiple predicate devices OK Collect key components

11 Key Components Product list with part numbers for all products to be cleared, including all relevant accessories Engineering drawings for all components on product list Device Description especially characteristicsnot obvious from the drawings (e.g., description of surface treatment and process used) Material Certifications or Material Standards acceptable to FDA Key Components Labeling copies or drafts Instructions for Use (Package Insert) In English Product Labels, with text for most symbols Surgical and/or Prosthetic Manuals Product Brochures List of all claims for which clearance is requested Key Components Packaging description and drawings Planned sterilization method and validation plans including corresponding accepted FDA standard Testing completed (including protocol or standard to which the protocol is written, and final test reports) 11

12 12 Format of a Traditional 510(k) FDA Guidance August 12, sections Some may not apply Maintain numbering and titles Sections of a 510(k) Cover Page Table of Contents 1. Medical Device User Fee Cover Sheet (Form FDA 3601) 2. CDRH Premarket Review Submission Cover Sheet (k) Cover Letter 4. Indications for Use Statement (k) Summary or 510(k) Statement 6. Truthful and Accurate Statement 7. Class III Summary and Certification Sections of a 510(k) 8. Financial Certification or Disclosure Statement 9. Declarations of Conformity and Summary Reports Include Standards Data Reports (Form FDA 3654) for each standard referenced in submission 10 Executive Summary 10. Executive Summary 11. Device Description 12. Substantial Equivalence Discussion 13. Proposed Labeling

13 13 Sections of a 510(k) 14. Sterilization and Shelf Life 15. Biocompatibility 16. Software 17. Electromagnetic Compatibility and Electrical Safety 18. Performance Testing Bench 19. Performance Testing Animal 20. Performance Testing Clinical 21. Other Steps in Writing a 510(k) Write Device Description Summarize bench testing Summarize animal testing (if applicable) Summarize clinical study (if applicable) Write text for other sections Biocompatibility Sterilization and shelf life (include packaging) Write Substantial Equivalence section Steps in Writing a 510(k) Complete administrative sections FDA User Fee Cover Sheet CDRH Cover Sheet 510(k) Cover Letter Indications for Use Statement Indications for Use Statement 510(k) Summary or 510(k) Statement Truthful and Accurate Statement Class III Summary and Certification (if applicable) Financial Certification or Disclosure Statement (if applicable) Declarations of Conformity and Summary Reports Executive Summary Certification re clinical trials databank (if applicable)

14 14 Submitting the 510(k) Submit TWO paper copies or ONE paper copy and ONE electronic (pdf) copy If electronic copy is submitted, see for format Include MS Word file of text for reviewer use Retain an identical file copy Use 8.5 inch x 11 inch paper 3 hole punch left margin Your fancy binder will be discarded (probably used for employee children s school projects) Use 8.5 Complete administrative sections FDA User Fee Cover Sheet CDRH Cover Sheet 510(k) Cover Letter Indications for Use Statement 510(k) Summary or 510(k) Statement Truthful and Accurate Statement Class III Summary and Certification (if applicable) Financial Certification or Disclosure Statement (if applicable) Declarations of Conformity and Summary Reports Executive Summary Certification re clinical trials databank (if applicable) Submitting the 510(k) Submit by traceable courier service to: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center WO66 G New Hampshire Avenue Silver Spring, MD For 510(k)s reviewed by CBER, send to: FDA/CBER 1401 Rockville Pike HFM 99, Room 200N Rockville, MD What s Next? Administrative review for completeness FDA acknowledgement letter Includes assigned K number not a clearance FDA has 90 calendar days to review a Traditional 510(k) Premarket Notification i Target for questions is 75 days FDA has 30 days to review a Special 510(k) Reviewer may call sponsor or consultant with questions If questions can be resolved easily, a hold might be avoided

15 15 What s Next? Questions may come by , FAX or letter (request for additional information AI Letter) Submission will be placed on hold Stops FDA 90 day clock Starts sponsor 30 day clock Et Extensions automatically ti granted tdon request, to a total t of 180 days When sponsor submits response to questions, FDA clock starts running again FDA might ask a second round of formal questions Submission will be placed on hold Stops FDA 90 day clock Starts sponsor 30 day clock Extensions automatically granted on request, to a total of 180 days What s Next? Generally no opportunity for third round of questions If all questions answered satisfactorily Substantially Equivalent letter Clearance to market If reviewer and FDA management not satisfied Not Substantially Equivalent letter Device is Class III Some NSE letters read more like AI letters Invite resubmission as 510(k) with additional information Usually requires clinical or animal data Questions?

16 16 Key FDA website links Classification database 510(k) database Guidance document database GuidanceDocuments/default.htm Device Advice Key FDA Guidance (General) Format for Abbreviated & Traditional 510(k)s GuidanceDocuments/ucm pdf Certifications re clinical trials databank User Fees and Rf Refunds for 510(k)s GuidanceDocuments/ucm pdf Bundling Multiple Devices or Multiple Indications in a Single Submission GuidanceDocuments/ucm pdf To contact us Floyd Larson or Kevin Thomas PaxMed International, LLC Office (858) flarson@paxmed.com kthomas@paxmed.com

510(k) submissions. Getting US FDA clearance for your device: Improving

510(k) submissions. Getting US FDA clearance for your device: Improving Getting US FDA clearance for your device: Improving 510(k) submissions Audrey Swearingen, RAC Director, Regulatory Affairs Telephone: +1 512.222.0263 Email: aswearingen@emergogroup.com Download this white