Tag Archives: FDA

9 Steps to right first time regulatory compliance

It can be a scary thought, regulatory compliance.  So much to get your head around, so much to make sure is done right, and what is “right” anyway.

Wouldn’t it be handy to have a “crib sheet” to help you get there with less pain, in a shorter time, whilst simultaneously supporting development of a good medical device.

1. The right regulation?

May sound a bizarre first step, yet it is surprising just how many projects don’t adequately consider this question.

  • Be clear about the primary purpose for your medical device, and the mode of action.
  • Then, check the definition of “medical device” in the MDD (Article 1, 2 (a) through to (c)).
  • Does your product fit the description of a medical device? If, yes, then the MDD applies.
  • Does your product fit the description of an in vitro diagnostic device? If yes, then the IVD applies.
  • Does your product clearly not fit with any of the descriptions?  You can get advice (in the UK) from MHRA on borderline cases.  Similarly, you can access EU wide borderline device decisions, and the reasoning.

Remember to also consider other EU legislation that your product may need to comply with.  And, if you have an eye on other markets, look at how their requirements may differ from those of the EU.

2. Are you setting out to solve the right problem?

What is the problem or clinical need that your product is intended to resolve?  Is the problem widespread or isolated to a small aspect of healthcare in one country?

Answering this question will clarify the potential market size and clinical pathway(s) where the device can be used.  Your focus is then narrowed onto developing a product to address a specific need.  You can always expand into other clinical pathways or markets with a future version of the product.

Ultimately, you’ll have started to flesh out the product’s “Intended Use”, the bedrock upon which development rests.  Get this right, and the foundation is secure.

3. Put a Quality Management System in place

Arrival of the Medical Devices Regulation (MDR) explicitly requires a Quality Management System to be put in place for all classes of Medical Device.

The difference between the lowest risk medical devices and the higher classes is one of QMS certification.  For the Class 1, non-measuring, non-sterile medical devices, a manufacturer self-certified QMS is perfectly fine.  Otherwise, a Notified Body certification is needed.  Make sure you adopt the correct QMS certification route for your device.

4. Good Development Practice

“Begin with the end in mind” as Steven Covey said.  As you develop your device, picture how the documentation will come together for the submitted device.

The Design History File and Risk Management activities will tell the story of development, demonstrating why and how you arrived at the eventual solution.

The Technical File will provide the complete dossier of information that describes the medical device manufacture, assembly, testing and release requirements.

Robust, applied Documentation Control and Change Control ensure that you minimise the opportunity for surprises popping up at the end of development.  Start Change Control at an early stage in development, so design decisions are captured and can be referred to easily when answering regulatory authority questions on the submission.

Traceability Matrices should be your (new) best friend – they’re invaluable in ensuring that you’ve covered all the bases during planning, designing, testing and reporting.  If they’re created as you go along, headaches will be smaller than if gaps are spotted when the matrix is created at the end of development.  You may even consider a matrix for the Essential Requirements, to ensure you have documented evidence of compliance with each one.

5. Use Harmonised Standards

Check the most recent update to the European Commission’s list of Harmonised Standards, to see which are relevant for your medical device.  Manufacturers or conformity assessment bodies can use them to demonstrate that products, services or processes comply with relevant EU legislation.  So following the content of a Harmonised Standard is usually the straightforward route to demonstrating compliance.

6. Take care constructing your Technical File

Make it easy for the reviewer to navigate your Technical File, from a high level overview through to the detailed content that they’ll want to read through.  Adopt a logical layout to presentation of information.  There’s a handy template for the content of your Technical File provided by IMDRF (for a medical device, and for an in vitro diagnostic device).  The IMDRF documents are a few years old now, however the MDR contains a detailed description of Technical File content in Annex 2.

7. Your Clinical Evaluation Report

It won’t have escaped your notice that the MDR includes explicit requirements for Clinical Evaluation and its reporting.  There are two major benefits to getting underway with your Clinical Evaluation early in development:

1. The results of your research feed directly into the definition of Design Inputs (what the device needs to be able to do for the user / patient),

2. You have a clear picture of any Clinical testing that is required for the device, permitting realistic budgeting and planning of the project.

8. Post-market Surveillance Plan

Ensure that your QMS incorporates a good system for Post-Market Surveillance (PMS), covering vigilance activities, steps taken for pro-active PMS as well as reactive PMS (i.e. when you’re alerted of a problem, perhaps via a complaint), post-market clinical follow-up.  Naturally, all this is supported by a plan for PMS, that pulls all these threads together and demonstrates how information will be used to instigate or confirm design changes, how PMS information feeds into CAPA, Change Control and Complaint Handling processes.

9.  Managing Devices in the field

Remember to include activities to provide for CE Marking of your medical device prior to placing it on the market (for Class I non-measuring, non-sterile, this can be self-managed, for all other Classes, a Notified Body must be involved).

Consider what requirements you have for any servicing, maintenance and performance verification while the device is in service, and across its in-use life.  These will need to be documented and tested to verify their effectiveness in ensuring continued device performance and safety.

Getting it right, first time

There can be a lot to take in, working through these 9 steps.  Rest assured, help is at hand, should you wish for some guidance or support along the way.  Get in touch today, so we can explore how best to ensure you reach your goal of regulatory compliance, right first time.

FDA finalises Human Factors Guidance – Existing products – Part 4

In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

The document, published on 3 February, is the result of nearly 5 years of consultation with industry since releasing a draft guidance back in 2011.

FDA HF guidance FINALWe have covered a lot of ground already. In the first 3 parts, we heard about four of this list of the key topics covered by the Center:

  • Human Factors Engineering process
  • Risk Management and Human Factors
  • Design Verification
  • Summative Human Factors testing
  • Changes to products already on the market
  • Human Factors Engineering Summary report

In part 4, we’ll look at the Human Factors Engineering Summary report and submission of your HFE data. You may then want to think about how this may impact what you’re either already doing, or plan to do.

Changes to products already on the market

You may be wondering how this relates to devices that are already on the market? The agency has provided some guidance to help you understand when modifications to a device mean that it should undergo validation testing. The need for additional human factors validation testing should be based on risk management planning and risk analysis for the modified User Interface or Tasks, to determine the scope and nature of testing required and should focus on those hazard-related use scenarios and critical tasks. The test may, however, be limited to assessment of those aspects of users’ interactions and tasks that have only been affected by the design modifications.

The agency also recommend that for any further human factors validation testing consideration should be given to user’s comparison of the design modification to the previous design.

Human Factors Engineering Summary report

It’s often seen as the culmination of your HFE programme.

Expectations for content of the report have expanded, to require far greater information about analysis and elimination/reduction of risks and hazards associated with use of the device, critical tasks and use scenarios. Far greater detail is needed about the validation study, discussing test environments, training correspondence to real-life, data collection methods, test results, feedback, analysis of use errors, difficulties, root causes of problems and implications for risk elimination/reduction.

The Center are proposing to require submission of HFE data with your PMA or 510-K, for those devices where users performing tasks incorrectly or failing to perform tasks could result in serious harm. There’s a separately issued, draft, guidance that outlines current thinking on which devices would need this as a matter of course, which may well change between now and the final version of that document.

However, the agency has not removed the expectation that a human factors programme is present as an integral part of a robust design control system.

So you still have to do it, you just may not always need to include an HFE Summary report in your submission dossier.

When is the guidance effective?

You will have some time to assimilate the requirements…
A whole month, as they go live on 3 April 2016.
How will these changes will affect your product development?

What impact they will have upon your Human Factors Engineering programme?
Get in touch today to discuss how you can best navigate the changes and emerge with a Human Factors programme that is “just right”.

FDA Finalises Human Factors Guidance – summative testing – Part 3

In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.
We have already taken a look at the first three in this list of the key topics covered by the Center:

  • Human Factors Engineering processFDA HF guidance FINAL
  • Risk Management and Human Factors
  • Design Verification
  • Summative Human Factors testing
  • Changes to products already on the market
  • Human Factors Engineering Summary report

In part 3, we’ll look at how the topic of Human Factors testing (both formative and summative) may impact what you’re either already doing, or plan to do.

Formative Human Factors testing

Look upon this stage of testing as providing a toolkit to identify potential use-related hazards and hazardous situations. The agency emphasises the value of testing with participants who are representative of your intended users, as this yields early data on how your eventual users cope (or don’t) when using your prototype device.

The agency recognise that formative evaluations provide information about;

  • Design of the user interface (those parts of the device that are manipulated by the user, provide them with information or indicate function)
  • The effectiveness of features or changes implemented to reduce or eliminate use errors (otherwise known as mitigations)
  • The the need for training of users and inform the design of training materials
  • The design and content of labelling such as the Instructions For Use, product labelling, packaging.
  • The content and design of your summative testing.

In the guidance, the Center talk about the value of effective formative testing in preventing very costly errors in the design of your validation test protocol that render it just another formative study.

In a departure from previous guidance, there is information on the expected content of formative test protocols, which creates a coherent and building picture that results in the information now expected for your HF validation test protocol. It’s very much a case of using formative studies as building blocks that provide a robust foundation for your validation test.

Summative Human Factors testing

Summative testing is still in place. However, testing that demonstrates the “user requirements” or User Needs have been met will henceforth be referred to as “Human Factors Validation Testing”. One could perhaps see this as coming into line with the philosophy applied to validation of processes, test methods, production lines, etc

No longer does guidance expect you to just include critical tasks within your test design. Rather, the testing needs to be comprehensive, so that the results can be related to actual use.

Test participants

If your device is intended to treat patients with a condition that can cause them to have functional limitations, these conditions must be represented during both the formative evaluations and your HFE validation study. If you choose not to design your device to accommodate needs of those likely to use your device, then labelling should clearly explain the capabilities that users must have to use the device safely and effectively. You should, therefore, ensure that you’ve understood your Users’ needs thoroughly and scoped out the Usability Specification appropriately to know what capabilities/limitations are to be included in study participant groups.

Participant Training

If you anticipate that most users of your device would receive minimal or no training, the Center now expect that participants in your validation study do not receive training.

A period of time between training and participation in your validation study should be built in to the study design. How long that is will vary, depending upon what would happen in real life and the impact of training decay on the use-related risks that you’ve identified for your device. The important thing is to consider this topic and document your rationale for the chosen approach.

Study protocol

Manufacturers are now formally encouraged to submit draft HF Validation Test protocols for agency review, to ensure that the methods you plan to use are acceptable (via the pre-submission programme). We’ve been fortunate to have supported several clients in developing and submitting draft protocols to CDRH, so have benefited from a “heads up” about many of the changes that are now embodied in this final guidance document. The review can be a great way to confirm that your approach to HF Validation will satisfy expectations.

If testing of labelling formed part of the validation study, the agency now require this to be conducted separately after simulated use testing.

The test protocol must provide a rationale for the extent of device use and the number of times that participants will use the device. This means frequency of device use must be considered; for devices that are used frequently and have a learning curve that requires repeated use to establish reasonable proficiency, testing should allow participants to use the device multiple times, if appropriate.

Data collection should include capture of observational and knowledge task data and should be supplemented with subjective data through the use of de-brief interviews with the participants after the use scenarios are completed. The purpose of the de-brief is to assist with understanding of possible root cause of use errors detected during testing.

Study location

It has long been understood that there is an expectation for the validation testing to be performed in the US. It is an expectation that hasn’t been removed, as the results of studies performed in other countries may be skewed by differences between healthcare practices, cultural and language differences. However, the agency are open to considering exceptions, on a case by case basis, where there is a sound rationale that addresses the differences. In any case, as you might expect, the device, labelling and training must be those that would be used in the US. So, in the vast majority of cases, it is likely that testing in the US would be more straightforward.

When is the guidance effective?

You will have some time to assimilate the requirements…
 
A whole 5 weeks, as they go live on 3 April 2016.
 
How will these changes will affect your product development?
What impact they will have upon your Human Factors Engineering programme?
 
Get in touch today to discuss how you can best navigate the changes and emerge with a Human Factors programme that is “just right”.

FDA finalises Human Factors Guidance – Part 2

In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to Medical Devices”.

FDA HF guidance FINALIn part 1, we looked at both the Human Factors Engineering process and Risk Management and Human Factors, two of the key topics covered by the Center:

  • Human Factors Engineering process
  • Risk Management and Human Factors
  • Design Verification
  • Summative Human Factors testing
  • Changes to products already on the market
  • Human Factors Engineering Summary report

Lets look at how the topic of Design Verification may impact what you’re either already doing, or plan to do.

Design Verification

Design Verification has vanished from a Human Factors perspective – probably a relief for device development teams who were scratching their heads about what was needed in addition to Design Verification as described in ISO 13485 and 21 CFR §820.30 Design Controls.

So now, we can focus on Design Verification being all about confirming that the design outputs (i.e. the device design and associated specifications for performance and attributes) meet the design inputs (what you wanted the device to be able to do). It’s about physical evaluation and testing of devices to confirm, for example, that the force required to turn a dial meets your specification limit. To confirm that the robustness and mechanics of your design function as intended.

Now that might sound straightforward, just get some sample devices from (pre-)production and test them, right?

Design Verification tests shouldn’t be “tick box” tests. Sadly, that’s often what is done by way physical testingof Design Verification, however this misses the fundamental point of verifying the design – to confirm that the device performs as required, throughout the range of your specifications. Design Verification demonstrates that devices manufactured/assembled with components from all across your specified ranges actually do work together, and more than that, they work as intended. Verification shows that your “design envelope” works in practice. It also gives you reasonable confidence that, when your manufacturing and assembly processes vary (within your specification) which they will do, the end product is safe to place on the market. And in the long run, that should mean less surprises.
Certainly, the scale of Design Verification can vary hugely, depending upon the number of components, their manufacturing process variability and so on. But it doesn’t need to be a big deal.

You need to be able to rely on the results of Design Verification

Taking care to plan, design and execute DV is a great step on your journey to getting your product on the market. Consider how you will know you can rely upon the data that are generated and analysed.

We’re often asked whether test equipment need to be qualified and test methods validated? You could take the approach of using development equipment and test methods that are not yet optimised. How will you be able to show, to your board and investors, that DV is truly representative of production data?

The long and the short of it is;

  • Qualify your test equipment before using it for DV,
  • Optimise and then validate the test methods you plan to use during DV.

Take both steps and you’ll have a high degree of confidence that the results you get are translatable to production and routine inspection situations. And there’s the added bonus that you would have needed to do the work anyway during industrialisation and launch preparation.

Spare yourself the nightmare of discovering at that late stage that there was a critical issue with the way you planned to release batches of product onto the market.

When is the guidance effective?

You will have some time to assimilate the requirements…

A whole 6 weeks, as they go live on 3 April 2016.

How will the changes will affect your product development?
What impact they will have upon your Human Factors Engineering programme?

Get in touch today to discuss how you can best navigate the changes and emerge with a Design Verification programme that is “just right” – you know, “fit for purpose”.