Tag Archives: regulation

Which option would you choose?

You’re running late, you’re hungry and won’t have another chance to pick up something to eat before your journey.

There’s a busy food retailer nearby, and you go in to find something to tide you over, scanning the sandwiches, wraps and salads. A couple of the products on offer look safe to eat, but there’s no labelling on the shelf or the wrapper about allergens.

You are faced with three options;

  • Buy the product that looks like it would be safe to eat,
  • Leave the shop and search for something else, or
  • Join the queue for the counter and when you finally get there, ask for the allergens information folder, to search through for the information you need.

Which option would you pick?

For those with food allergies, It is hard enough finding safe foods to eat when you’re out and about. How challenging it must be, especially if you’re not confident in public, to have to ask at the counter for information on allergens. You’re then probably confronted with a folder full of hard to find, hard to read information.

When you’ve plenty of time to sift through the information, it’s a large emotional burden. When you’re pressed for time, how much harder must it be to take those steps.

For many in the UK, the unfolding story from the family of Natasha Ednan-Laperouse this week was heartbreaking. The paucity of legal requirements for food labelling was hammered home by the experience of Natasha’s Grandmother, who went into her local branch of the national chain in question, and asked for allergen information for the same sandwich her Granddaughter had eaten. She recounted the stress and difficulties experienced in asking for and then struggling to understand allergen information from within a folder.

As of this Wednesday, the company at the centre of the storm have agreed to steps that ought, one might be forgiven for thinking, have been in place for years – placing food allergen information on freshly made products. The company were complying with the law on food labelling. However, that law includes a loophole permitting establishments that prepare food freshly on the premises to simply have a folder available on request with allergen information. It is even permissible to impart the information verbally to the customer.

It shouldn’t take the death of a person for change to happen, but so often it does. In light of the Coroner’s findings in this family’s case, a review of current Food Labelling legislation has been promised by the UK Government.

You only have to look at the history of medicines regulation to see that many pieces of legislation were put in place as a result of human tragedy. Thankfully, there are now regulatory requirements for labelling and Instructions for Use on all medical devices and drug / device combination products

Even so, when developing a new product we must be mindful of what else the user or patient may have to contend with whilst using our device. Ask yourself, is it reasonable and practical to use the materials we provide with the product. If the answer is “no”, how else might the product be designed to reduce uncertainty over its use, how could information be better provided, to be more readily accessible to the user?

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.


Getting your medical device into the NHS

Getting a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown.  Having a map for this journey would be an attractive proposition.

To flesh out our map for the journey, we joined around 30 other industry experts for Medilink East Midland’s July 2018 conference “How to get your medical device NHS ready”, held in conjunction with Nottingham University Hospitals NHS Trust.

The day covered a range of subjects, all geared towards giving you the knowledge to best prepare your medical device for a favourable review outcome for the NHS.  Amongst the topics we discussed were;

  • The impact of Human Factors in medical device development,
  • Patient Public Involvement – why it’s so important and how to access it,
  • Regulatory support for medical device development,
  • How to undertake a clinical investigation in the NHS,
  • Using a budget impact assessment to support uptake and adoption,
  • NICE engagement and support for developers.

A number of case studies were also shared, demonstrating the value achieved by considering specific topics of the agenda.

We left the event with a clear picture of how our core disciplines supported, and could be woven throughout, the preparations for NHS “readiness”, over and above regulatory authority approval.  We’re now applying that knowledge to help our clients’ development activities.