I mentioned in an earlier post that the best way to avoid waste is to consider Medical Device Regulatory Requirements at the outset of the project, rather than try to meet regulatory obligations when the design is complete. 

Medical device development is a fast moving, innovative field. President Ronald Reagan said: ‘If it keeps moving, regulate it.’

This blog post attempt to fill out some of the things you should be considering at the start of your formal design process, rather than trying to meet these at the end.

Intended Use

This is a special phrase to most regulatory bodies, and is the key to all medical devices.  Unfortunately, many entrepreneurs and inventors do not consider formal intended use statements until late in the project.  The intended use should be parts of the User Requirements or included in the Design Plan.

Target Market

The next thing you should consider is: where do you want to sell?  Your business plan may have an initial breakdown of particular markets for testing and then ramp up later.  However, the regulatory implications may require you to revisit this assumption.  For example, China is an emerging market with a large population (the elevator pitch goes ‘we only have to hit 0.01% of the population to make a gazillion dollars’), but the regulatory pathway is difficult to navigate for outsiders and may take years. Alternatively, you may be based in the US, but upon investigation it appears that there is no suitable predicate which would allow you to get test units on the market to meet your investor deadlines.  After further review, Health Canada or the EU appear to be an easier route for market testing since the risk classification may be lower, depending on the device.

Device Risk Class – Device Product Code

Most regulatory bodies classify devices based on risk of harm to patient or operator.  The FDA has simplest classification for the risk of device – Class I, Class II, Class III.  The European Union and Health Canada have variations with four categories.  If you find out your device is FDA Class III, which is the highest risk and requires an expensive and time consuming Pre-Market Approval (PMA) ahead of time, then you can plan (or even abandon) accordingly.  Note that a class I device in one jurisdiction does not automatically mean class I device in another, and must be reviewed accordingly, which is why it is important to consider your marketing jurisdictions.  I put the device class is in the Design Plan for the various target markets.

Device Product Code/Preferred name

Both the FDA and Health Canada have defined product codes for a large number of medical devices.  These also define the risk class for many devices.  The FDA also helpfully identifies any standards which they require your device to conform to.  For example, FDA product code DQA is a pulse oximeter, is FDA Class II and must conform with ISO80601-2-61:2011.  For Health Canada, the device code is 74AAV, and the risk class is Class 3.

Regulatory Pathway

If you have a simple Class I device, your Regulatory Pathway may be straightforward. However, generally anything which is sterile or has a measuring function is class II or higher, and will have more stringent requirements. For example, in US the Pre-Market Notification, commonly called 510(k), is used for Class II devices which are substantially equivalent in terms of technology and indications for use, to existing, legally marketed devices, which requires selection of an appropriate predicate device to compare against.  Some class II devices, such as Audiometers, are exempt, whereas other devices may unexpectedly require a 510(k), such as menstrual tampons. Even then, 510(k) vary from device to devices: some only require side by side bench testing, some require pre-clinical testing (such as IVDs), and some require human clinical data.  As mentioned in a previous blog, there is definite value in going to market with simple 510(k) and extending the indications for use over time, rather than trying to get initial regulatory clearance for a device with very many indications.  –Narrowing indication for use ahead of time is invaluable for identifying if any features are required for the 510(k) or differ substantially from similar devices, which may endanger the 510(k) premise.

Quality Management System (QMS)

Is a quality system required in order to market your device, and should this cover both design/development and manufacturing?  Generally, FDA Class II and III  devices require Quality Management system, which formalizes key processes employed by the company.  The two main QMS are Quality System Regulation (QSR) required by the FDA, and ISO13485 required in Canada and the European Union.  QSR comprises Good Manufacturing Practice (GMP)  and Design Controls.  In the US, most Class I devices must comply with GMP requirement, and some specific Class I devices must comply with Design Controls.  Both of these systems require formal procedures in place, but only ISO13485 requires you to be audited by a certifying authority ahead of time.

Consensus Standards

The aim of standards is to demonstrate safety and/or performance.  ISO13485 was discussed above, but there are a host of other standards, which can be broadly defined as process or performance/safety.  Process standards describe a recognized method of undertaking a given task: for example, ISO14971 describes how subjective hazards and risks may be quantified and acted upon. In addition to standards, the FDA has Guidance Documents, which means you must have a jolly good reason for not following their guidance. For example, if your device contains software, then your software should comply with IEC62304, which is a process standard for designing medical device software, but must also comply with FDA document  ucm089543  ‘Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices’ if you are submitting a 510(k).

Essential Performance

Particularly relevant to both the European Union and IEC60601 testing, the concept of Essential Performance must be defined for your device.  These are often specified in an accompanying 80601/60601 collateral standard, but if not, you will need to define Essential Performance and show this is not degraded during testing, such as EMC testing for electrical devices (IEC60601-1-2).  For example, Essential Performance for an electrically powered operating table (according to IEC60601-2-46) is ‘Freedom from Unintended Movement’, and this should be in the Design Plan.