BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE. Yuan Xu 18- JAN- 2018

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1 BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE Yuan Xu 18- JAN- 2018

2 Background AGENDA What is Medical Device? What is 510(k)? Principles of best practices of device changes Two new FDA Guidances -25 OCT 2017 Cases studies Q & A 2

3 Medical Device 3

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Evaluation and Research CDRH Center for Devices and

6 Offices of Medical Product Regulation within the U.S. Food and Drug Administration (FDA) CBER Center for Biologics Evaluation and Research CDRH Center for Devices and Radiological Health CDER Center for Drug Evaluation and Research 6

7 FDA Mission 7

A risk based approach for medical devices since 1976 Increasing Risk Classification determines extent of regulatory control (Risk Based) Class I General Controls

Electronic Device Listing Quality Systems Labeling Medical Device Reporting (MDR) Premarket Notification [510(k)] (unless exempt) http://www.focus42.

8 A risk based approach for medical devices since 1976 Increasing Risk Classification determines extent of regulatory control (Risk Based) Class I General Controls Class II General controls Special controls Class III General controls Premarket approval (PMA) 55% 40% 5% General Controls Electronic Establishment Registration Electronic Device Listing Quality Systems Labeling Medical Device Reporting (MDR) Premarket Notification [510(k)] (unless exempt) 8 Special Controls (addressing Risk) Guidelines (e.g., Glove Manual) Mandatory Performance Standard Recommendations or Other Actions Special Labeling (e.g., , Cranial Orthosis) 8

9 List of Regulations apply to Medical Device 21 CFR Part 820: Quality System Regulation (QSR) 21 CFR Part 807: Registration and Listing/ 510(k) 21 CFR Part 814: Premarket approval (PMA) 21 CFR Part 50, 56: Clinical Studies/IRB 21 CFR Part 812: Investigational Device Exemptions (IDE) 21 CFR Part 801, 809: Labeling 21 CFR Part 803: MDR- Medical Device Reporting 9

10 Devices Exempt from 510(k) ~800 devices or 47% total devices are exempt from 510(k) ~ 730 or 93% of Class I ~ 70 or 9% of Class II 10

11 What is a 510(k)? Marketing Clearance Process for a new or changed device Show Substantial Equivalence (SE) to the predicate device SE means Just as Safe and Just as Effective Paragraph (k) of section 510 of the Food Drug and Cosmetic Act, also called Premarket Submission or Premarket Notification (PMN) 11

12 When a 510(k) is required? The device is being introduced into commercial distribution for the first time or Significant Change to Existing Device 510(k) shall be submitted 90 days before the new or changed device introduces into the market [21 CFR (a)(3)] 12

13 21 CFR (a)(3)- Regulation How to interpret significant or major change? 13

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16 Intent of the new guidances Enhance the predictability, consistency, and transparency of when to submit a 510(k) Promote a least burden oversight of modified devices Ensure timely access to modified devices 16

17 Key Principles Least burden Change Control 17

18 #1: Risk-based assessment (ISO 14971) To make initial determination of whether the change is a significantly affect the safety or effectiveness of the device. 18

19 Change is significant if introduces a new risk, or modifies an exiting risk or risk controls that could result in significant harm or affect clinical functionality or performance specifications a NEW 510(k) is likely required 19

20 Major change in (IFU) indications for use, e.g. from prescription use to OTC use added new patient population Changes in frequency or duration of use a NEW 510(k) is likely required 20

21 Significant Changes also includes: e.g. sterilization, cleaning or disinfection package integrity or shelf-life claims device design Changes to employ wireless communication human factors of the patient or user interface material type, formulation or chemical composition a NEW 510(k) is likely required 21

22 Complex software changes e.g. Change core algorithm Change overall architecture Change Infrastructure Software Change is also called bug fix, hot patch, tweak, Refactoring, Reengineering, patch Code change Code maintenance a NEW 510(k) is likely required 22

23 NOT significant if the change Do not impact any risk controls and add new risks Do not affect clinical functionality Do not affect performance specification related to IFU Not require a new 510(k), document design change according to QSR 23

24 NOT Significant SW changes: Change alarm duration Strengthen Cyber security Adding encryption and additional access control for remote users Proactive software security patch Modify system to meet specification Correcting DICOM retrieve parameter error 24

25 # 2: Review and Approve the Changes Make sure there is NO unintended consequences of changes e.g. Changes in sterilization may unintentionally affect device materials Changes to materials may unintentionally affect the performance of the device 25

26 #3: Verification and Validation Verification Did I make the product correctly? Validation Did I make the correct product? Any change that can not be fully verified must be validated/revalidated 26

27 #4: The role of testing (V&V) Reconsider the significance of a change if A change drives need for new V&V since previous version are no longer applicable Unexpected issues are encountered during routine V&V. E.g, acceptance criteria cannot be met 27

28 #5 Documentation Document all Changes and approvals, regardless if a new 510(k) is required or not. Must comply with QSR 21 CFR Part 820 to document the device changes. Especially document the rationale of weather a new 510(k) is required. 28

29 Elements of the documents Product Name Date of Assessment Device Description Description of Changes Reason why the Changes are being made Applicable Regulatory History(e.g 510(k) number and version of the device) and comparison of the modified device to current device (e.g. Table) Rationale for the regulatory action Recommended Regulatory Action Submit 510(k) or Letter to file Supporting documents (e.g) Risk-Based Assessment Design and Verification and Validation Summary Signature 29

30 #6 Contents for a new 510(k) When prepare a new 510(k), should include all the changes in the submission package. Including the prior changes did not trigger a new 510k. E.g. If a warning in the device s labeling has been changed, even if this change itself did not trigger the 510(k), shall be described in the new 510(k) 30

31 #7 Simultaneous/Multiple Changes Should be assessed both separately and together Cumulative effect of individual changes may triggers 510(k) If only one change triggers the 510(k), the other changes may be implemented immediately (as long as those changes can be implemented independently) 31

32 # 8: Combined Changes: Software and Non-software Changes Should evaluate both changes and If either assessment leads to a New 510(k) conclusion, submission of a new 510(k) is likely required. 32

33 Case Studies A new 510(k) is required or Documentation is sufficient 33

34 Case Study #1: Change description: The manufacturer adds a foreign language translation of the direction of use to a device s labeling. Rationale: The translation does not change the meaning of the instruction, and not affect the device s risk profile. Decision: Documentation on file is sufficient. 34

35 Case Study #2: Change description: An IVD manufacturer makes a material change to their reagent and the riskbased assessment indicates that the change could result in a potential change in the cut-off. Rationale: Even though the change in material is not alter the operating principle, but would result in a change in the cut-off which is clinically significant of clinical decision making since patients with samples around the cut-off could receive a different diagnosis and treatment. Decision: A new 510(k) is required 35

36 Case Study #3: Change Description: The device is an imaging catheter for coronary arteries that includes lasers and optical components. The manufacturer modified the device software to integrate new optical modules and a new advanced laser method. Rationale: This change poses new risk to patients as a result of the new control parameters for the laser could result in patient injury if not integrated appropriately. E.g when optical module not recognizing the new catheter and therefore providing the incorrect laser setting, which could result in significant harm to the patients. Decision: A new 510(k) is required 36

37 Case Study #4: Improve sample throughput 1 Change Description: A manufacturer makes a software performance enhancement to improve sample throughput time by 20%. Software modifications include changes to decrease assay cycle times by allowing for shorter sample reaction incubation times. Rationale: The change Decreasing sample assay times could have an significant impact on run performance and/or assay performance in a manner that could have negative impact on diagnosis or therapy delivered to patients. Decision: A new 510(k) is required 37

38 Case Study #5: Improve Sample throughput 2 Change Description: A manufacturer makes a software modification to improve sample throughput by 5% by decreasing pre-analytical processing time. Software modifications include a change to decrease sample delivery time from the sample load area to sample aspiration area. Rationale: The modification do not impact assay performance as it relates to intended use. Improvement resulted from technical analysis of the sample delivery algorithm to optimize timing and remove unnecessary timing delay. Decision: Document the change to file. 38

39 Case Study #6: Change Description: A device is modified to use an internal battery instead of an external AC power source. Rationale: This is an energy type change, which could significantly affect safety or effectiveness. Patient could get electric shock if power did not ground correctly. Decision: A new 510(k) is required 39

40 In Summary Evaluate changes using Risk-based assessment Evaluate both Safety and Effectiveness All changes must be made in accordance with the Quality System regulation, 21 CFR 820 Reviewed/Approved/Documented/V&V Justification for submitting or not a new 510(k) must be documented 40

41 References: FDA Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device October 25, 2017 FDA Guidance: Deciding When to Submit a 510(k) for a Software Change to an Existing Device, October 25, 2017 ISO Application of risk management to medical devices 41

42 QUESTIONS? For additional questions, 42

43 Additional Topics available by Focus 42 LLC: 1. Medical Device: Compliance & Audits 2. Medical Device: Medical Device Software development process 3. Medical Device/IT: Risk Management 4. Least Burden - Medical Device Software Regulation Strategy 5. Medical Device: How and when to conduct IT/Software /Computer System Validation 6. Medical Device: 21 CFR Part 11 Compliance for SaaS/Cloud Applications 7. Medical Device/IT: How to compliance with FDA Cybersecurity requirements 8. Medical Device: How to apply Agile to SaMD Medical Device software development 9. Medical Device: Risk Management for biocompatibility evaluation 43

44 Services by Focus

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FDA 510(k) 101 The Basics

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