Regulatory approval for medical devices: ASCE and pre-market notification/technical file submission

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1 Regulatory approval for medical devices: ASCE and pre-market notification/technical file submission Nick Chozos 04 June 2014 PT/227/30028/1 Exmouth House 3 11 Pine Street London EC1R 0JH T F E office@adelard.com W

PT/227/30028/1 Exmouth House 3 11 Pine Street London EC1R 0JH T

2 Agenda FDA and assurance cases ASCE technical file schema Demo ADELARD LLP Slide 2

3 Background: infusion pumps An infusion pump infuses fluids, medication or nutrients into a patient's circulatory system. It is generally used intravenously, although subcutaneous, arterial and epidural infusions are occasionally used. Infusion pumps are used in the hospital or at home. ADELARD LLP Slide 3

It is generally used intravenously, although subcutaneous, arterial and

4 ADELARD LLP Slide 4

5 Medical systems Tempo Heterogeneous systems Patient s own devices Accidental systems Ad hoc Apps Off label Local and global Multi-stakeholder FDA Policy on Infusion Pumps Health Foundation Report ADELARD LLP Slide 5

Local and global Multi-stakeholder FDA Policy on

6 FDA and assurance cases Medical device industry the latest to introduce assurance cases Since 2010, FDA requires assurance cases as part of 510k premarket notification submissions for new infusion pumps The FDA describe an assurance case as a formal method for demonstrating the validity of a claim by providing a convincing argument together with supporting evidence Although currently just for infusion pumps, possibly for other devices in the future ADELARD LLP Slide 6

assurance case as a formal method for demonstrating the validity of a claim by providing a convincing argument

7 Motivation behind new guidance Review of Medical Device Reports (MDRs) found: 56,000 MDRs related to infusion pumps, 710 deaths, 87 recalls Several design problems (e.g. software, user interface) seen as preventable Subsequently, FDA evaluated several pumps and manufacturers to conclude that there are numerous systemic problems with device design, manufacturing, and adverse event reporting FDA concerned new devices will be more problematic given the increasing use of software FDA decided to proactively and systematically address the root causes of infusion pump recalls ADELARD LLP Slide 7

8 FDA assurance case requirements FDA requires that an assurance case is used to demonstrate that the system is: Safe and effective substantially equivalent to predicate devices ADELARD LLP Slide 8

9 Demonstration of safe and effective FDA recommends that 510(k) submissions: include a risk management report and the other documents identified below to demonstrate that the results of risk management activities were incorporated into the device design. These documents should be incorporated into the assurance case as arguments or evidence, where appropriate Risk file should contain: Risk management report System architecture Design requirement documents ADELARD LLP Slide 9

10 Demonstration of safe and effective Assurance Risk management Engineering ADELARD LLP Slide 10

11 Demonstration of safe and effective ISO 14971: Application of risk management for medical devices Effective risk management approach All risks are ALARP / acceptable Risk management report Results of risk management activities have been incorporated in the design System architecture Design requirements documents ADELARD LLP Slide 11

Risk management report Results of risk management activities have been incorporated

12 Assurance cases and 510k submissions Table of contents: 1. Device description 2. Indications for use 3. Device classification 4. Risks to health 5. Assurance case report 6. Clinical evaluation 7. Risk management k pre-clearance inspection 9. Labelling 10.Post-market surveillance ADELARD LLP Slide 12

Risks to health 5. Assurance case report 6. Clinical evaluation 7.

13 Assurance cases and 510k submissions 100s documents produced throughout the project lifecycle ADELARD LLP Slide 13

14 Technical file submissions In paper, but FDA will also accept ASCE files When substantial changes are made to the device, a new 510k submission will have to be made ADELARD LLP Slide 14

15 ASCE technical file schema We are developing a simple schema with: Aspects of project management (ownership, status, review status) Regulatory compliance (compliance status) Claims-Arguments-Evidence In the technical file package we are also using: DNRs for managing evidence changes/summaries Demo ADELARD LLP Slide 15

(compliance status) Claims-Arguments-Evidence In the technical file package we

16 Benefits of the technical file schema Manage the submission process (document evolution, review and compliance) DNR diffs help to construct the executive summary for resubmission All the usual ASCE benefits: CAE, exporting, user views etc ADELARD LLP Slide 16

help to construct the executive summary for resubmission All the

17 Summary FDA assurance cases for infusion pumps since 2010 Looking into expanding requirement for other types of device ASCE used by the FDA and several medical device manufacturers Technical file schema to support not only creation and management of assurance cases, but entire 510k submission process ADELARD LLP Slide 17

device manufacturers Technical file schema to support not only creation and

18 ADELARD LLP Slide 18

Safety Assurance Cases: What the medical device industry is doing

Safety Assurance Cases: What the medical device industry is doing Sherman Eagles SoftwareCPR seagles@softwarecpr.com BECOMING AWARE 3 Early steps to awareness 2005 EWICS TC7 medical device group begins