Tag Archives: FDA

9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.

The 22 page document makes for heavy reading, so we’ve highlighted some of the key points that you should be aware of as you manufacture or develop medical devices for the US market.  Many of the changes will have a positive impact upon your preparations for marketing authorisation submissions; 510(k), PMA, De Novo, IDE, etc.

 

1. 510(k) exemptions

FDA periodically reviews premarket and post-market activities to identify Class I and Class II devices that no longer require a 510(k) submission.  The list of exemptions is regularly updated, so it is worth checking before setting your regulatory strategy for a new medical device.

2. Enforcement discretion

Additionally, enforcement discretion is being exercised for certain products, to focus oversight on medical devices that could pose a higher risk to patients.  Information can be found for specific product codes by searching the FDA product classification database for submission type: “Enforcement Discretion”.

3. Changes to part 820

As we recently reported, FDA plans to replace parts of 21 CFR 820 (Quality System Regulation) with requirements of ISO 13485:2016, harmonising with other key regulators around the globe.  This will remove a significant barrier to entry for manufacturers, particularly the smaller organsiations.

4. Aligning expectations with other regulatory authorities

FDA expects to be in a position to leverage data and regulatory decisions from other regulatory authorities, by aligning requirements other regulators’ requirements.  The focus will be on reviewing scientific data, rather than the methods used to generate it. The agency plan includes recognition of additional international standards, to facilitate the move.

5. A “bottom-up” approach to request for information

FDA will request from manufacturers the minimum information needed to address questions or issues. The agency will consider a “bottom-up” approach to data requests, so in some cases descriptive information (such as dimensional analysis or materials comparisons) may be all that is needed. If that proves insufficient, it may be that some non-clinical performance testing data is required.  Animal or biocompatibility data or ultimately data from clinical investigation may be requested if none of the earlier data sources provide adequate data to address the question or issue at hand.

6. Manufacturer submissions

Manufacturers will be expected to submit materials that are “least burdensome” to review/assess.  Your documentation needs to be concise, well organised and clear.  Including rationales for responses to agency questions will go a long way towards expediting review and promote open communication with the FDA.

7. Use of post-market surveillance data

Consider where post-market surveillance data can be utilised, instead of gathering new data from pre-market investigations.

8. Alternatives to Clinical Investigation

Alternative sources of clinical data, such as;

  • Peer reviewed literature,
  • Data generated outside of the US,
  • Real-world evidence and,
  • Well documented case histories,

may be used, where it is appropriate to help assessment of device safety and effectiveness.

9. “families” of medical devices

Bundling of submission documents to cover multiple devices, or indications, within a single submission, may be an appropriate route for agency review, where scientific and regulatory issues for the devices / indications can reasonably be dealt with in the same review.

Related Information

As you’ve read this far, it’s fairly safe to assume that the topic of regulations and quality management interests you.  You can search and read other articles in this topic here: http://threecircles.eu/category/quality/

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories.

Often, manufacturers wrestle with ensuring that their development process, activities and documentation aligns with both ISO 13485 and the Quality System Regulation (21 CFR 820).

US FDA has announced plans to harmonise the requirements contained in 21 CFR 820 with the content of ISO 13485:2016.  There is planned to be a fundamental revision to part 820, that will “supplant the existing requirements” with the content of the revised 13485 standard.  The agency intends the changes to reduce the compliance and record keeping burdens on manufacturers.

For the canny development organisation, little will actually change, as they will have planned their activities to achieve compliance with both the US and other territories requirements at the same time.  FDAs intentions will make their lives a little easier, removing the need for  translations between, for example document names, from the standard and part 820 terminologies.

For people embarking upon development with an eye on the US market for the first time, there’s likely to be one less hurdle to surmount once FDA’s intentions bear fruit.

Ultimately, the plans are good news for manufacturers who develop and market products for the EU, Japan, Canada, Australia (and the US), as all have regulatory requirements aligned with a single Quality Management Standard – leading to a reduction in compliance requirements for manufacturer Quality Management systems.

You may be thinking about seeking reassurance that your medical device development plans adequately address the regulatory requirements of the US and ISO 13485:2016 aligned regulations.  Get in touch with our team today.

 

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”.