FDA Partners with Silicon Valley: A New Frontier in Medical Devices

by | Oct 6, 2017 | Medical Devices

Wearables That Diagnose by Design

We can now peer into our genome and microbiome to assess our individual risk of disease, but soon dynamic data will enhance our ability to choose the most effective medical care. Health related apps, trackers and software create robust data sets with the capacity to move personalized medicine into new territory. The real-time communication of biometric information to physicians, researchers and consumers allows for informed decisions to provide the best quality of care.

With an eye towards the health-monitoring market, tech titans like Apple and Alphabet are expanding their wearable technology to encompass tasks like measuring oxygen levels in blood or abnormal heart rhythms. Disruptive technology like this faces unique challenges in the healthcare industry. The FDA recognizes both the potential and challenges of digital health technology innovation and has partnered with select leaders in the medical device and technology sectors to create a streamlined process for safely delivering these powerful tools to the public.

Regulation That Doesn’t Impede Innovation

To enable innovation in digital health technology, the FDA launched the Pre-Certification for Software Pilot Program. Unlike traditional medical devices, software development is the focus of regulation as opposed to a product. The necessity for frequent updates and upgrades, as well as the truncated commercial cycle of new product roll outs requires a new regulatory process to ensure that innovation is not stifled.

The Pre-Certification for Software Pilot Program aims to create a regulatory framework to review systems for software design, validation, and maintenance to determine if a company meets the required quality standards to become “pre-certified”.  Pre-certified companies would benefit from an abridged approval process before marketing new digital health tools, provided the software and internal processes are sufficiently reliable.

This partnership with large and small companies began in August and will report on preliminary findings and challenges at a public workshop in January 2018.

Preparing the FDA for the Digital Health Revolution

Not only is the FDA providing guidance on legislation and reinventing regulatory processes, they are also broadening their expertise to prepare for the expansion of digital health technologies. User fees will be used to support new staff members with a deep understanding and practical knowledge of software development and its application to medical devices. Additionally, the FDA is launching an Entrepreneurs in Residence Program to invite organizational and operational input from thought leaders in software development.

The Digital Health Innovation Action Plan details the FDA’s efforts to advance innovation in digital health technology to help people receive the right diagnosis, better manage chronic diseases, as well as, seek preventative care.


Emma International

Emma International

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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