Tag Archives: FDA

A flurry of activity from FDA

fda draft guidances list 2016-02-05It’s been a busy week for the US Food and Drug Administration’s CDRH.  In the space of a couple of days, the Center has published one final and two draft guidances related to Human Factors.

Just over a month into 2016 and the Center has already achieved 3 of its stated priorities for the year, with the release of these documents;

  • Applying Human Factors and Usability Engineering to Medical Devices (Final Guidance),
  • List of Highest Priority Devices for Human Factors Review (Draft Guidance),
  • Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (Draft Guidance).

We’re hard at work in the office analysing the content of these documents, so we can give you a summary of the changes and requirements for your teams developing medical devices or combination products.  We’ll be publishing a summary of the key pieces of information next week.

You may want to know how these guidances impact your planned or ongoing development activities.  Send me an email matthew(Replace this parenthesis with the @ sign)threecircles.eu?subject=I'd like to talk with you about the recent FDA guidance documents&body=I read your post about recently published FDA guidance documents and would really like to fix a time with you to find out more about how they will impact my development programme.%0A%0AHow are you fixed for time to talk on the following days:

Human Factors high on FDA Priorities for 2016

So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have been many blog posts published summarising the 10 priorities, as they “serve to accelerate improving the safety, effectiveness, performance and quality of medical devices”.

But why the emphasis?

Why Human Factors matters

Hopefully, as you’re reading this, you’ll already be aware of why98000 Human Factors is integral to safe products. As a refresher, here’s why;

  • 80% of medical device errors are due to human error.
  • Every year, around 98,000 people die in hospitals in US, 11,859 in England, due to medical errors, many of which are due to Use Errors.

“Many device recalls and adverse event reports reflect underlying human factors engineering problems including usability issues and preventable design problems” (FDA CDRH)

Yet we spend a lot of time during development working to reduce the 20% of errors that are due to device performance, testing our devices to ensure the build quality is robust and that the performance is acceptable.

What about working to reduce the 80%?

CDRH priorities include Human Factors

Well, CDRH included Human Factors in their priorities because it helps;

  • Facilitate medical device innovation and bring new technology to market,
  • Enhance or expedite the availability of medical devices while maintaining their safety and effectiveness,
  • Facilitate rapid identification of problems.

What does all this mean for those medical devices or combination products already in development?

A great emphasis will continue to be placed upon adequate and robust Human Factors programmes during development. Programmes that clearly identify who the product is being build for and their needs, demonstrate the integration of Human Factors throughout design development and culminate in evidence that the product is safe and effective in use (i.e. a robust summative usability study).

It is perhaps not surprising that the focus for 2016 includes HF, as there’s been much dialogue between industry and regulators in recent years on this topic, including the wider implications of devices being used outside the clinical setting (see our post on that topic from January 2015).

Merging of EU and US Human Factors requirements

The playing field between EU and US requirements is being levelled (our September 2015 post discusses this in detail). For the EU, developers now need to provide the same Human Factors programme evidence as for the US. So, consequently, the focus on Human Factors will be higher in the EU too.

You may well be thinking that, if you’re developing a product for several markets, it makes sense to develop to meet US Human Factors requirements, as that will satisfy 99% of the needs of the EU and other major world markets.

What does this mean for your product?

You may be thinking about how you could best ensure your development programme meets the requirements for Human Factors.

Pick up the phone (+44 1270 61 86 93) or click on the “Get in touch” tab to the right of your screen to explore how we can help you ensure your product is “right first time”.

Further reading about Human Factors

Perhaps reading this article has left you wanting to find out more about the world of Human Factors (also known as Usability).  There are two things you can do:

1. If you’re new to HF or would appreciate a refresher, you will be interested in reading our book “How Humans Factor (in medical device design)”.  Email us to request your free e-copy.

2. Have a read of other recent posts on the topic of Human Factors:

CDRH New Year’s resolutions

The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016.

In line with the Center’s published priorities for 2016 (more on that next time), the application of human factors and usability engineering to medical device design makes it onto the list, as well as incorporating patient preferences into device premarket approvals.

FDA 2016 Guidance priorities

The resolutions are split into

  • The A List (those draft and final guidances the FDA “fully intends to publish”), and
  • The B List (those that will be released “as resources permit”).

We are curious to see which of the comments made by industry are included in the Final Guidance documents.

You can read what others in the industry, such as Eli Lilly, Smiths Medical and GSK, are saying at the US government website www.regulations.gov. Search for the relevant guidance document (e.g. human factors FDA will find the agency’s draft guidance document on that topic).

Amongst the Final topics that made it onto the A List are:

  • General wellness products
  • Medical device accessories
  • Incorporating patient preferences into medical device premarket approvals, humanitarian device exemptions, and de novo classifications
  • Applying human factors and usability engineering to optimize medical device design
  • Post-market surveillance studies under section 522 of the Food, Drug, and Cosmetic Act
  • Medical device reporting for manufacturers

Draft guidance topics that reached the A list included:

  • Medical device decision support software
  • Use of symbols in labelling
  • Software modifications
  • Companion diagnostics co-development
  • Use of real-world observational patient data to support decision making for medical devices
  • Public notification of emerging post-market medical device signals

The B List also has some guidance topics which are keenly anticipated, however these will only be progressed if resources and time permit during 2016:

  • Blood glucose monitoring test systems for prescription point-of-care use (Final)
  • Self-monitoring blood glucose meters for over-the-counter use (Final)
  • Medical device interoperability (Draft)
  • Patient access to information (Draft)
  • Defining the UDI (Draft)

It doesn’t stop there, as there’s been a wealth of Guidance published by the agency over the past few decades. The FDA has asked for feedback on many Guidances published more than 10 years ago, to see if they should be revised or even removed.
Of note are:

  • Do It By Design (the FDA’s 1996 introduction to Human Factors in Medical Devices)
  • Post-market Surveillance under Section 522 of the FD&C Act (a 2006 Final Guidance)

Read the FDA proposal here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm467223.htm

Closing the gap between EU and US Human Factors requirements

Medical device manufacturers can have a tough time gaining approval of new devices in the US, due to the increased scrutiny of the usability aspects of device design. To some the EU has been seen as a little more “relaxed” when it comes to testing and documenting device usability; the usability engineering process for medical devices is implied and not demanded as part of regulatory submission.

But now, the playing field is levelling out.  The standard for Usability/Human Factors ( IEC 62366) was recently updated to IEC 62366-1: 2015.  May seem like a subtle difference, yet the content change is significant if you’re developing either a combination product or medical device.

IEC 62366 was closely tied with the Risk Management standard, ISO 14971: 2007 and crammed full of examples of processes and documentation. Until this year, 62366 only required that a Usability Engineering File was created and that usability studies were carried out to verify and validate the safety of the medical device design. Now, however, the usability engineering file must contain results of both formative and summative testing,  Summative testing is used to verify and validate the medical device design (IEC 62366-1:2015 subclause 5.9).

There is also now an expectation that summative testing will find use errors that must be analysed, to identify the root cause and determine whether their severity warrants further risk control measures.

Ambiguity over setting study acceptance criteria has been removed at a stroke. Gone are the days when the Human Factors standard used to imply that, for example, a 90% success rate in correctly using the device was acceptable. The focus has now clearly shifted to examining what happened to the 10% who failed to use the device correctly and the consequences for user safety.

All these changes to study design and acceptance criteria requirements will bring EU activities closer to the FDA requirements.

As Europe tightens the usability requirements of medical devices, the only remaining difference between the FDA and the EU is; at what point will the regulators ask to see your Usability Engineering process; pre or post regulatory dossier submission?

If you need help and support or would like a quick chat about your usability engineering programme, get in touch to learn how we can help you improve the usability of your product.