Several years ago, at the start of the Open Voice Factory project, it became clear that we’d need to register the Open Voice Factory, or some part of it, as a medical device. It was publicised to, in the words of the relevant european directive ‘mitigate handicap’, and so it needed to be registered. There is NO moral way around that.
It also became clear that there were almost NO other open source medical devices. Or at least, none that could be found. The only documentation was largely incomprehensible and everything was guarded. Nobody had put their technical file online, almost nobody wanted to say what their technical file contained.
I swore that by the end of the process I’d write the document I wanted at the start.
It will be a while before I can write that post, but I promise that I’ll put everything relevent here in the meantime.
Currently, that’s relatively little (well, it’s 6,000 words, but most of the good content is at the bottom). But I try and give you most of the information I have.
As a result of the Nesta Prize we had £10,000 in fees we could give to consultant to help us through this process. We wanted to do everything right, and so we got professionals in. I’ve reproduced the majority of the correspondence (or at least everything that might be useful to another project like ours) below. It’s all entirely focused on our situation and, as written below, nobody takes any responsibility for the advice within.
In the coming months I hope to be adding our technical file to this post, as well as doing updates to the correspondence, and some content from the people helping us make the technical file.
This is the letter we sent to the MRHA originally: MRHA letter.
It started with:
Jul 11, 2016, 3:44 PM
The first of the emails
Sep 20, 2016
I’ve just received the following feedback from our software consultant. I asked him if he thought your technology would be regulated as a device. He noted:
‘Possibly – from the MDD : “compensation for a handicap” . Neither of the 2 competitors below mention anything about regulation / consideration as a medical device !
From MEDDEV 2.1/6 – if the software only communicates data, then it is not covered by MDD.
There are 2 questions: is enabling speech is a medical benefit to the patient ?; does the device do more than communicate data ?
I think it would be worth asking MHRA’
If you could provide feedback on the two underlined questions we can consider further.
Thu, Sep 22, 2016, 3:12 PM
Tue, Oct 4, 2016, 8:44 AM
Tue, Oct 4, 2016, 11:31 AM
Fri, Oct 7, 2016, 12:20 PM
Wed, Oct 12, 2016, 4:59 PM
Mon, Oct 17, 2016, 4:43 PM
Oct 18, 2016, 2:42 PM
Dear Mr. Reddington,
I hope all is well. My name is Patrice and I am part of Emergo’s project management team coordinating your Device Classification project. I would like to thank you for entrusting Emergo with this project. My primary job function is to ensure that all project related work progresses successfully, so please feel free to contact me if you ever have any concerns regarding your account. Below I would like to discuss some project details with you.
As per the proposal the scope is currently defined as follows:
Emergo provides support with device classification for AzuleJoe (5 budgeted hours).
- E-Quality Time Limited wants to determine if the technology would be classified as a Medical Device under the Medical Device Directive (MDD).
- Emergo will prepare a document to be sent to the UK Competent Authority (MHRA) to ask for their determination of the classification.
- It is recommended that E-Quality Time Limited send the final document to MHRA as this, in our opinion, solicits a better response.
<some information removed as it pertains only to Emergo’s internal workings>
Wed, Oct 19, 2016, 9:19 PM
I have the links and information provided to Colin in September.
I assume I should prepare the MHRA enquiry from the perspective of AzuleJoe *not* being a medical device ?
Thu, Oct 20, 2016, 3:46 PM
Thu, Oct 20, 2016, 3:57 PM
Thanks Joe – I will reason the classification using the MHRA guidelines, so that the view we present is clear – and hopefully the MHRA will agree – but point out flaws if necessary.
Sun, Oct 23, 2016, 9:06 PM
I’ve worked through the MHRA guidance again – please see my discussion doc attached, and the MHRA guidance.
The key question is on the medical definition of what azuleJoe does for a user – if the phrase “Compensation for a handicap” is appropriate for enabling speech, then the device is considered a medical device !
Based on this assumption, it would be class I, which is a low regulatory burden.
Please review and comment ? if a call would be a good idea, please suggest a time on Tuesday ?
Tue, Oct 25, 2016, 1:34 PM
Fri, Oct 28, 2016, 9:29 AM
Please find attached the letter for the MHRA.
I suggest you could send to X – who has responded to prior requests about software.
Mon, Nov 7, 2016, 1:25 PM
Mon, Nov 7, 2016, 2:50 PM
Timescales on response from the MHRA should be in less than 4 weeks – but no knowing !
After that – if CE mark is required, it can be done fairly quickly – your technical team would do most of the work, but the technical file could be assembled in 2 or 3 months.
In terms of quoting – it might be best to check what you want to quote – we issue disclaimers that information provided is solely for the particular customer, and information for you may not be applicable to a wider audience. In the regulatory space, it’s seldom a case of “one size fits all” !
Thu, Nov 10, 2016, 3:27 PM
Thu, Nov 10, 2016, 7:33 PM
Yes – and I think that would be fine if you acknowledge Emergo as the source.
(included only because you’re reading that very blog)
Thu, Feb 2, 2017, 1:21 PM
MHRA have come back to us with:
Firstly I must apologise for the lengthy delay in replying to your enquiry due to unforeseen staffing issues.
With regard to your letter we would tend to agree with your opinion that the product is likely to be a Class I medical device under Rule 12.
What’s the next step?
Thu, Feb 2, 2017, 1:40 PM
This is a typical MHRA response – they don’t give a strong opinion ! This is perhaps a borderline decision, and the only way to get a firm opinion would be through the courts.
The next step would be to build up a technical file, on the basis of which you can sign a declaration of conformity and apply the CE mark to the product.
If you’d like Emergo’s assistance in this process, I can request a proposal be sent to you .
Thu, Feb 2, 2017, 1:48 PM
That’s interesting – when you say technical file – what would that look like?
Thu, Feb 2, 2017, 3:06 PM
A technical file is a summary of the product – how it works, and for a product like this will be about 20 documents, written to comply with 3 standards – risk management, software life cycle development and usability. A few of the documents address regulatory requirements.
Tue, Feb 7, 2017, 12:40 PM
Cool, do you have an example laying around somewhere can we could use to get our heads in the right place for moving on? We also need to start talking about US regulation as well.
Wed, Feb 8, 2017, 9:16 AM
There is no “one size fits all” – but below is a typical list of documents you would expect to see in such a tech file:
User Requirement Specification
Software Development Plan
Risk Management Plan
Risk Analysis Report
Software Requirement Specification
Verification Test Plan and Specification
Verification Test Results
Validation Test Plan and Specification
Validation Test Results
Usability Engineering Plan
Essential Requirements Checklist
Declaration of Conformity
Technical File Table of Contents
Clinical Evaluation Report
Usability Engineering Report
Release Design Review
Wed, Feb 8, 2017, 12:19 PM
Cool. We’ll get started – what’s our next move in terms of the US?
Wed, Feb 8, 2017, 12:29 PM
We need to identify a predicate device – a similar device already in use in the USA – can you suggest one/more ?
With this info, I can check to advise what will be required.
Wed, Feb 8, 2017, 12:42 PM
Thu, Feb 9, 2017, 11:59 AM
I’ve searched the FDA databases – and not found anything related to speech or speaking assistance. This leads me to assume that such a device would be 510k exempt or un classified – and the only way to confirm this would be to submit a 513g to the FDA which is a request to confirm classification, which is difficult here as we don’t have one !
Neither of the 2 you listed below show up ! so I suggest that we submit an RFD to the FDA http://www.fda.gov/RegulatoryInformation/Guidances/ucm126053.htm#IID
There are still some hours in this project, and I could draft and send such an RFD in an hour or so – let me know if I should proceed.
Thu, Feb 9, 2017, 12:29 PM
That would match our understanding. Please do
Fri, Feb 10, 2017, 7:06 AM
Emergo colleagues advised that an RFD is for a combination device, and a better option would be an email – which I’ve sent off – see below… we should get an answer in a few days…
We are assisting a company (in the UK) that has developed a speech aid for those who are unable to speak. The device is software, running on a tablet or similar computing platform.
The user indicates what they want to say by selecting icons on a touch screen, then the software builds a phrase or sentence which is digitally generated and played through a loudspeaker for others to hear.
The device may be viewed here: http://www.theopenvoicefactory.org/
The device is considered a medical device in some countries, and the company would like to know if this device is considered a medical device by the FDA, and if so, a classification for the device. We have searched the FDA classification database, under the Ear, Nose, Throat panel, but not found any suitable product code.
We would appreciate your assistance,
Tue, Apr 25, 2017, 9:29 AM
I’ve removed a bit of haggling where I was asking for a summary that I could give to funders. We ended up with this, which I’ve included as a fair summary.
Ok – my text can be as follows:
The MHRA have confirmed that the device can be classified as a Class I medical device. CE marking for a Class I medical device is a self-declaration, based on a technical file against which a declaration of conformity can be signed by the manufacturer.
It is not clear whether the product requires clearance from the FDA. Accordingly, we have submitted an enquiry to the FDA seeking clarification. The standard FDA response has been that “this evaluation process may take 60 or more days”. Other than a request for an update, we are not able to advance the FDA clearance process at this stage.
If this text is sufficient, I can apply to a letterhead. It will need to go through a peer review process within Emergo, which may take a day or two.
Mon, Jun 12, 2017, 3:22 PM
- What is the penalty (other than being sued if it goes wrong) for failing to register a device.
- What happens when we change the code (as in, fix a bug or add a feature)? Do we have to re-register?
- Does porting an app to a new piece of software need another registration process (i.e. do we have to do this seperately for iPhone and Android devices)?
- Are there any examples of tech files anywhere?
- Is there an open list of other devices that are registered as medical devices? How much information do companies/regulators have to publish on the topic?
Mon, Jun 12, 2017, 7:51 PM
See responses below…
- What is the penalty (other than being sued if it goes wrong) for failing to register a device. – I don’t know – would need to check with MHRA / lawyer
- What happens when we change the code (as in, fix a bug or add a feature)? Do we have to re-register? No – just sign a new DoC for major revisions
- Does porting an app to a new piece of software need another registration process (i.e. do we have to do this seperately for iPhone and Android devices)? – only if intended use or mode of operation changes. You can define the product as multi-platform
- Are there any examples of tech files anywhere? Not sure – but there is a guidance – attached
- Is there an open list of other devices that are registered as medical devices? How much information do companies/regulators have to publish on the topic? Not much ! MHRA has a listing of class I devices, but there is no detail other than company name
Fri, Jul 7, 2017, 10:38 AM
Good afternoon Joe,
I hope you are well. I am emailing with a quick project update.
Brian last checked in with the FDA in May, but we have still not received a response. They did indicate that it could take 60 days or more, but we are uncertain when or if they will reply. How would you like to proceed? Would you like us to send another reminder? Please advise.
Project hours: 3.75 hours worked (1.25 hours remain).
Fri, Jul 7, 2017, 12:48 PM
Fri, Jan 19, 2:51 PM, 2018
Good afternoon Joe,
I hope all is well. I am emailing to inform you we did not receive any response to our follow up with both the Device Determination distribution group DeviceDetermination@fda.hhs.gov or DICE@fda.hhs.gov (only an automated response). We had also reached out internally to another colleague in the US (who suggested DICE) and she commented that it is unfortunate they did not respond and they have had more than enough time to do so. I have noted that this has also occurred in at least 2 other projects where we sent emails for feedback and I am not certain what the reason for their unresponsiveness may be.
At this time, I wanted to check in to see if you would like any further assistance under this proposal (161007-57210)? Or how would you like to proceed? There are still 1.25 hours remaining.
Tue, Jan 23, 2018 5:32 PM
Wed, Feb 14, 2018 11:24 AM
Good afternoon Joe,
I hope you are well. My apologies for the delayed response. We have not tracked this for all offices, so I meant in my experience we had this happen a few times (so probably more along the lines of 3/30 although this would be a guesstimate as I do not have numbers for informal FDA email inquiries sent by other offices/Project Managers).
However, as I mentioned, we still have a bit of consulting time left so we would be happy to continue to try to outreach to the FDA to try to push for a response. Please let us know how you would like to proceed.
Mon, Feb 26, 8:31 PM
Tue, Feb 27, 1:18 PM
Good afternoon Joe,
Thank you for your reply. I will let Brian know to try another outreach to the FDA.
Regarding your other inquiry, I will put you in touch with my colleague in Business Development, Mr. Rehema Mussanzi (in copy), who can assist with providing information on Technical Files and what Emergo can offer to support.
We also have a resource library on our website with some free information to get you started. For example a white paper on Preparing a European CE Technical file for a Medical Device or a video on In-Depth: Europe CE Marking Medical Device Approval and Compliance with a brief segment on preparing a Technical File.
Wed, Feb 28, 6:13 PM
Awesome, will look forward to hearing form Rehema
Mon, Mar 5, 7:38 PM
Thanks for requesting the whitepaper about European Tech Files. Please click this link to download (PDF):
For additional information about Europe, check out our Library: www.emergogroup.com/resources/
Monday, 23 April 2018 3:56 PM
(first ever response from the FDA – sent to Emergo rather than eQuality Time)
Dear Brian Goemans,
Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA’s Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.
If your product meets the definition of a medical device, it will be regulated as a device.
A medical device is defined in Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act; or 21 USC 321(h)) as “an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or [which is] intended to affect the structure or any function of the body of man or other animals … .”
For regulatory information about your medical device of interest, please search the Product Classification and Establishment Registration & Device Listing databases to check if a device similar to your product is listed with FDA. I found a list of speech related devices on the Product Classificationdatabase. You can use this database to search for other products you plan to import into the U.S.
If you are still unable to determine whether your product is a medical device, please contact the Center for Devices and Radiological Health (CDRH) Device Determination Officers, Office of Compliance, via e-mail atDeviceDetermination@fda.hhs.gov for their determination. Within your email, please include a complete description of your product and its intended use, as well as any draft promotional material and labeling that you might already have. Please note that they do not determine the classification of a device nor do they determine whether a premarket application is required. The Office of Compliance will only provide their determination of whether or not your product is a medical device.
If you have more software specific questions I would recommend you email our software experts at email@example.com.
Meanwhile, here is a list of digital health related references.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
- Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
- Mobile Medical Applications
- Cybersecurity [Homepage]
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct. 2, 2014)
- Postmarket Management of Cybersecurity in Medical Devices (Final – Dec. 28, 2016)
- Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (issued January 2005)
- Information for Healthcare Organizations about FDA’s “Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software”
Meanwhile, I will provide you with information on how to market a medical device in the U.S.
Registration and Listing
To register with FDA, please review the Device Registration and Listing, Who Must Register, List and Pay the Fee webpages and follow the instructions on How to Register and List. You should also review information on Entry Process and Importing into the U.S.
It is the responsibility of manufacturers to classify their medical devices.
Medical devices are classified based on intended use, risk and the level of control necessary to provide reasonable assurance of their safety and effectiveness. There are three regulatory classes of medical devices: Class I, Class II, or Class III. The regulatory class of a device type is defined in Section 513(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(a)). Review the information on Regulatory Controls to learn about the types of regulatory controls applicable to each class of medical device.
If you need help with classifying your device, you can submit a Request for Classification (513(g)). The 513(g) request fee is on the FY 2018 MDUFA User Fees list. If you wish to directly contact the Office of Device Evaluation, please refer to the CDRH online directory for the appropriate contact information.
If you qualify as a “small business,” you will be eligible for a reduced fee for some types of CDRH submissions that require a user fee. Please review theSmall Business Determination Program webpage, and the FY 2018 Medical Device User Fee Small Business Qualification and Certification guidance document for information regarding eligibility and the application process. A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.
If a device requires premarket application submission, the owner or operator should send to FDA the required premarket submission such as: Premarket Notification 510(k), Premarket Approval (PMA), Humanitarian Device Exemption (HDE) etc. Review How to Study and Market Your Device for information on premarket submissions. Note that most Class I devices and a few Class II devices are exempt from the premarket notification 510(k)requirements, subject to the limitations on exemptions. Please review theMedical Device Exemptions requirements.
Finally to legally market a medical device in the U.S., manufacturers must register their firms and list their devices with FDA. Manufacturers also have the opportunity to market devices, which do not require a premarket submission, for up to 30 days before they register and list with FDA.Registration is done annually. It is the responsibility of manufacturers to meet all FDA requirements before registering and listing. Importers too should register with FDA, but they do not have to list products. Importers must ensure that their foreign manufacturers or vendors have registered and listed with FDA. Foreign firms exporting devices to the U.S. should have a U.S. based agent. For more information on marketing a device in the U.S., please review the Overview of Device Regulation, and CDRH Learnwebpages.
The Annual Establishment Registration Fee for FY 2018 will is $4,624. See FY 2018 MDUFA User Fees.
Please note that not all medical devices legally marketed in the U.S. are considered FDA “approved.” The term FDA “approved device” specifically refers to Premarket Approval (PMA). PMA devices are usually Class III devices. Similarly, the term FDA “cleared device” specifically refers toPremarket Notification 510(k). 510(k) devices are usually Class II devices and a few Class I devices.. Manufacturers are not allowed use the terms “approved” or “cleared” to describe devices that have not successfully gone through the respective PMA and 510(k) submission processes. Devices not requiring premarket submission can be marketed if a registered manufacturer lists them with FDA. Manufactures can also market such devices up to 30 days prior to listing them with FDA.
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Wed, Apr 25, 10:58 AM
It’s been a while – but at last there has been a response from the FDA !
Unfortunately the response has come from DICE – a response from Device Determination would have been more helpful !
However, referring to the definition below (linked from the email)
(h) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
I suggest that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 above, so is not a medical device.
Please consider this email below, and provide feedback ?
The interpretation above is informal – Patrice is away this week, but when she is back next week, I will discuss the next step – in Emergo an internal peer review is required to provide a determination of your device being a medical device or not.
Thu, Apr 26, 10:56 AM
That’s somehow worse… I’d assumed they’d burned it, rather than this simply the length of their backlog.
Fri, May 4, 2:39 PM
I hope all is well. I have not had any other informal device classification inquiries (for other clients) since last year, so I am not certain if they are having a substantial backlog. I can ask again internally with our US team if they have any recent feedback. I am also wondering if the FDA had just crossed it off their list (or forgot about it) until Brian sent a follow up.
I see that Brian has suggested that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 below, so is not a medical device. If you would like for Brian to research this further to make a formal (peer-reviewed) report and opinion, we could add around 4 hours to the project via a scope change.
Please let us know how you would like to proceed.
Tue, May 8, 3:12 PM
Bit confused, is that: “Brain can spend four hours writing a report for you” or “Brian can spend four hours writing a report and sending it to the FDA”?
Tue, May 8, 3:40 PM
Brian can write a report for you. He can do a more in-depth research and provide a formal advice/standpoint (from Emergo’s point of view).
Tue, May 8, 3:46 PM
I understood we are paying you because you know this area already. Why do you need four more hours to make a recommendation?
Tue, May 8, 4:21 PM
We certainly understand your frustration as the FDA did not provide conclusive answers. I can assure you that your business success is important to Emergo and we endeavor to support you however possible.
The initial proposal (161007-57210) was for Emergo to determine if the technology would be classified as a Medical Device under the MDD. Emergo recommended preparing a document to be sent to the UK Competent Authority (MHRA) to ask for their determination of the classification. We had up to 5 hours budgeted for this activity. Brian provided this deliverable (classification letter for the MHRA) in October 2016 and MHRA feedback was discussed in Feb 2017.
After the initial deliverable was completed, you engaged Brian to assist with reviewing US regulations under the remaining budget. Brian conducted a search of the FDA databases/reviewed competitors and, not finding anything related to speech or speaking assistance, determined the next logical step would be to submit an informal request for determination to the FDA. Brian drafted and sent the initial email to FDA Device Determination along with numerous follow-ups last year, finally drawing a conclusion from the FDA feedback we received that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 the FDA had listed, suggesting it may not be a medical device. Since there was limited budget from the initial ad hoc, Brian could not conduct a more in-depth review and instead supported as I’ve outlined here.
In order to provide an alternative approach to continuing to contact the FDA repeatedly (to no avail), we proposed a formal Emergo report. We base our approach on the experience we gain across many projects, but we do bespoke research and write reports for each customer since we cannot and do not claim to have the same understanding as the regulators. Therefore, we quoted the additional hours. Typically for a regulatory research project (from scratch), we quote up to 20 hours, so the 5 hours we quoted here took into account that Brian was already familiar with your product and had been working on the MHRA and FDA requests.
We look forward to your feedback on how you would like to proceed.
Here’s were we are at the moment. We’ve consulted with a developer who has experience taking software through medical device registration and who already has some familiarity with our work. Here’s the understanding we now have:
To register as a medical device you must produce a technical file. Part of that technical file is about the organisation itself – how do you decide what features to add, how do you assess risk and so on. To show this, we need to have a set of policies that cover the developement of the device, and, we need to be able to show that we are following them. So the process looks like this:
- Write and approve policies
- Wait (while writing the rest of the technical file)
- Check that we’ve been following our own policies (with evidence)
- Add the evidence to the technical file and submitt.
Our consulting developer has recommended the following five policies (based on his experience, this isn’t a standard set):
- Document Management,
- Risk Management,
- Continuous Improvement
- Post Market Surveillance
Now, the medical device rules say that you have to have a ‘state of the art’ process. It appears that you can either prove your own process to be state of the art, or follow one of the International Standards, on the basis that it’s understand that these standards establish the state of the art. The relevent standards here appear to be:
- IEC 82304, 6
- ICE 2304
- ISO 14971
- Possibly ISO 13485
The standards aren’t publically availible, in fact they are expensive to purchase, which is one of the other barriers to Open Source Projects getting medical device status. In any case they have statements like “There should be a throught process for X”, whereas the policies say “Our process for X is” so there should be some flexbility.