Category Archives: quality

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developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.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

Rising cost of compliance for medical devices in Canada

Our recent insight post highlighted a key change in Health Canada’s requirements for companies seeking authorisation to market their devices.  A change that is leading to disquiet amongst manufacturers for the Canadian market.

From 1 January 2019, Health Canada will only accept manufacturer audits performed under the MDSAP programme, closing the current conformity assessment system.  Manufacturers are not expected to make the switch overnight, however.  Health Canada published specific criteria in April, for manufacturers to preserve their current ISO 13485 certification and surveillance cycles whilst transitioning to the new arrangements.

Perhaps understandably, the change is causing consternation to manufacturers of smaller volume medical devices.  Companies are reporting a ten-fold increase in audit costs as a result of the change, an increase that is likely to hit small businesses hardest, according to a recent report by Canadian national newspaper The Globe and Mail.

Whilst having a successful MDSAP audit would aid registration in other territories, the way MDSAP audits are performed may result in a more lengthy and costly process for Canadian manufacturers.  The scarcity of resources to perform the audits, and the passage of time, may exacerbate the situation.

It should be noted that the regulatory requirements remain the same in 2019, it is the method for confirming compliance that will change.  Health Canada expect adopting the MDSAP requirement will “strengthen the post-market surveillance and risk management” for medical devices.

The Globe and Mail reports Health Canada as “offering to reduce, for small companies, the time spent performing the audit” alongside giving more time to have the audit completed, as long as its scheduling is done in 2018.

It has been said that the change could bring advantages to manufacturers in the EU and US looking to market their devices in Canada – as having a successful MDSAP audit stands them in good stead for registration in multiple countries. Closure of the Canadian conformity assessment system removes a hurdle for those companies, reducing the “cost of entry” somewhat.

This situation underlines the long-term benefits of considering regulatory requirements for a range of territories when developing medical devices, instead of focusing in on requirements of the launch market.

Only time will reveal the true impact of the change, on both domestic Canadian medical device manufacturers and those looking at entry into the country’s health care market.  We will keep you posted on developments.

 

Riding the wave of Software as a Medical Device

For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs of change have emerged over the past few months, in the US at least. And where the US leads, other territories will follow.

It’s probably little surprise, given that software apps rely upon a stable platform to operate effectively.

If, like us, you’ve ever experienced an update to one of the apps on your smartphone either “break” functionality or impact on how another, seemingly unconnected, app performs, then you will appreciate why this is a challenge that needs to be resolved.

FDA publishes and updates guidance documents

Signs of the changes for Software as Medical Devices (SaMD) are mainly found in the activities of the FDA (the US regulator for drugs and medical devices) and forms part of the US government’s drive to bring regulation up to date, by passing the “21st Century Cures Act” into law.

Agency guidances have since been published for a range of topics;

Clearly, FDA view the changes as important to the health of the US populace.  Taking the case of apps used to support drug treatment as just one example, here’s what the FDA commissioner, Scott Gottlieb had to say;

“Mobile devices and software linked to specific drugs can help patients stay on therapy for treatments where medication compliance is traditionally a challenge”

International guidance for software as medical devices

The flurry of activity comes on the heels of the last in a series of documents produced in the area by the IMDRF (International Medical Device Regulators Forum).

Perhaps you’re not too familiar with the work of the IMDRF? That’s ok, it is after all a rather niche topic. Regulators from the EU and 9 countries have been working together “to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device”.

Work completed by this IMDRF working group produced a suite of guidance documents relating to SaMD, including;

If you’re considering, or are already a long way down the path to, developing, pure software medical devices or “accessory” apps, such as those used to manage a chronic disease such as diabetes, then you need to be aware of the shift and adjust your approach accordingly.

Help is at hand for software as a medical device

Clearly, there’s a lot to take in with the swathe of documents, before assessing the impact the changes may have upon your development plans.

Over the coming weeks, we’ll be sharing insights for each of the documents mentioned in this article.

Subscribe (add your email to the box on the right of this page), to ensure that you’re alerted as soon as new information is published.

Perhaps you want to get to grips with the changes today?  Get in touch now.

ISO 13485:2016 – time is running out

Something may have escaped your notice in the talk about the revised version of ISO 13485, published in 2016 (ISO 13485:2016 is the International Standard for Medical devices — Quality management systems — Requirements for regulatory purposes).

ISO 13485 is a harmonised standard, which means you can use compliance with ISO 13485:2016 as evidence of conformity with the requirements of several EU Directives:

  • Medical Device Directive (MDD),
  • In-vitro Diagnostics Directive (IVD),
  • Active Implantable Medical Device Directive (AIMDD).

There is a transition period, after which certification won’t be possible to earlier versions of the standard.  To complicate matters, the transition period ends on different dates, depending upon your current certification.


Marketing medical devices in Canada?

You have until 1 January 2019


Current certification to ISO 13485:2003?

you have until 28 Feb 2019


No certification to ISO 13485:2003?

you have until 1 April 2019


In either case, the transition end dates may sound like a long time away yet.  Time flies, and if you’re considering certification to ISO 13485:2016, you have several steps to take, not least of which is to understand what you really must be doing to be ready for certification.  Don’t underestimate the time and effort required to get there.

Help is at hand!

No need to worry about how you’ll get ready in time.  We have helped clients make the transition to ISO 13485:2016 from either an informal Quality Management System, or holding an ISO 9001 certification.  Our experience and knowledge has been assembled into our 13485 Health-check turn key service, to give you a clear picture of how your organisation stacks up against the requirements of the standard. Benefits our clients say they’ve achieved include

A pain free assessment of what you need to do, so you can take the right actions.

Guidance and help for changes you make so you’re not shooting in the dark.

Frees you up to play to your strengths, instead of trying to get to grips with something outside your comfort zone.

What you get when we schedule your 13485 Health-check™:

  1. An on-site gap analysis of your current quality management processes and procedures against the requirements of ISO 13485:2016,
  2. Pre-planned for a date and time that is convenient to you,
  3. Recommendations for improvements or changes to address oversights or weaknesses,
  4. Recommendations for procedures and processes that may be required,
  5. Identification of changes that may be required to your existing procedures and processes,
  6. A comprehensive report detailing the origins of all our recommendations and how they relate to ISO 13485:2016 clauses,
  7. Time with us to create your action plan to address the recommendations.

All this for a single, fixed, fee.

Whether you hold certification to ISO 13485:2003, ISO 9001 or not, we can help ease your transition activities.

Get in touch now, before that clock gets any closer to zero.