With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently.
On Sept 11th, 2018 Apple obtained FDA clearance for their wearable consumer product apple watch which features include monitoring the heart both for EKG and irregular rhythm notification (click on links for FDA 510K summaries).
Coincidentally, the approval happened only days after Apple hit public market valuations of $1Trillion Dollars, a record for a US firm (although a couple soon followed). Both of these are newsworthy in their own right.
In light of the much-expected move of technology to modernize healthcare, specifically through Software as Medical Devices (SaMD) platforms, we analyse the basis for the approval of such features, the strategy used and what this means for innovators in this space. We also highlight regulatory pathways that may be opportunities worth exploring for innovators in the software as medical device space.
Firstly, what is a Software as Medical Device or SaMD?
The International Medical Device Regulators Forum’s (IMDRF) defines software as a medical device (SaMD) as:
Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
This purposefully broad definition includes:
• Both functions that perform typical medical device and diagnostic related tasks.
• Software that can run on general purpose computing platforms (i.e. watches or cloud-based)
• And finally, mobile apps that meet the SaMD definition
This definition is often confusing to developers, leaving some software that may not appear evident to be a stand-alone medical device actually requiring a stand-alone approval/clearance.
Apple’s new entrant strategy:
In consideration of the regulated FDA world, Apple pursued a de novo classification based on their inability to identify a legally marketed device upon which to base the determination of substantial equivalence and requested FDA for classification designation and de novo product categories.
Subsequently, within a month of the submission, FDA determined the risk classification for both of these as Class II medical devices and was granted DeNovo Designations.
The De Novo Option:
According to the FDA clearance documents:
Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two options for De Novo classification:
1) First, any person who receives a “not substantially equivalent” (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may request FDA to make a risk-based classification of the device.
2) Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device … without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing the classification.
As a result, FDA created the following two new categories in the Federal Registrar:
• Photoplethysmograph analysis software for over-the-counter use.
• Electrocardiograph software for over-the-counter use.
Note, both of these categories are marked as over the counter products not intended to replace traditional methods of diagnosis or treatment, however they are still classified as devices.
Our conclusions from Apple’s strategy:
• De Novo classifications are becoming increasingly popular for new manufacturers.
• Apple is setting the stage for over the counter wearables and an alternative pathway to new enabling technologies for wearables.
• The FDA approval timeline of 1 month provides some positive indication that FDA is taking a proactive stance on enabling new product technologies.
Meanwhile in Australia:
For firms in, or considering the Australian market, and following the TGA announcement on Aug 20 2018 which allows US 510Ks in addition to MDSAP as sufficient evidence for Australian market approval, obtaining a 510K could also open the doors to Australia. The TGA also allows the use of Canada and Japan registrations to support a TGA approval.
Manufacturers should consider that some products may be classified differently in Europe and Australia. If your SaMD is up classified, a 510K without any supporting clinical data would still be required to pass additional hurdles to obtain TGA approval. Therefore, a thorough understanding and analysis should be sought if a manufacturer wishes to pursue this option for registrations in Australia.
FDA’s efforts to generate a new SaMD focused framework:
A program that is also taking a lot of attention is the pilot program on Digital Health Software Precertification (Pre-Cert) Program, According to the program text:
“The purpose of the program is to help inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.”
The working model published by the FDA on June 2018 outlines a framework by which companies can achieve pre-certifications for the SaMD in order to generate a streamlined review and utilize real word data to monitor the performance of the SaMD.
Companies that have developed and evidenced a culture of quality and organizational excellence based on 5 Key Performance Principles, will be eligible for this pre-certification program. These Principles are:
1. Product Quality
2. Patient Safety
3. Clinical Responsibility
4. Cybersecurity Responsibility
5. Proactive Culture
According to the program’s working model, it will present a series of benefits to the SaMD industry. See Table 1 for an overview:
• If you are working in the SaMD or in the vicinity of this space, ensure you understand the product classification.
• Manage marketing and labeling claims accordingly.
• Expect a more streamlined process as more technologies are commercialized.
• Good news, SaMD is a growing industry, with the likes of Apple playing in this field, new innovations and pathways are expected to come
If you are developing a new software as a medical device, we can help with registrations, classification analysis, and regulatory strategies.
Looking to fly south for warmer weather? We are skilled in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us to discuss your needs and how we can help. You can drop us an Email firstname.lastname@example.org or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)