SOURCE: Sway Medical
The most anticipated document in the history of the booming field of mobile health should be here any day. The Mobile Medical Applications Guidance we’ve been waiting on for the past year could be published any day.  Or maybe it won’t be. There is a fierce battle going on over the release of the guidance and anticipation grows every day that it is not released. One of the most vocal, and well-regarded, individuals in the center of the debate is Brad Thompson, a counsel to the mHealth Regulatory Coalition, who has indicated his support of the FDA releasing the guidance immediately. In a recent Mobihealthnews article. Mr. Thompson provides a rational and factual round-up of the reasons why the final guidance should be released now rather than delayed until after a coordinated effort of regulatory agencies to introduce the HIT regulatory framework, as mandated by the FDA Safety Innovation Act of 2012 (FDASIA).
This uncertainty has created a growing hesitation of investors and entrepreneurs in the mobile health space that is a direct result of the FDA’s lack of action in publishing further guidance for regulation of medical on mobile. But it is important to remember that we are not waiting on new regulations and requirements for mobile applications that previously have not been in place.  We are simply waiting for further clarification on how the FDA proposes to enforce the existing regulations.  Making this differentiation highlights the lack of knowledge and experience of investors and innovators in the mobile health space and reaffirms the necessity of a strong quality control and regulatory expert who understands the landscape of mobile health and how to apply the current regulations to this industry.
There is a growing sentiment surrounding the final guidance that mobile health innovation is being hampered by the uncertainty around how mobile apps will be regulated, but a strong QA/RA director or consultant would know that is not the case.  A strong QA/RA professional would be able to help establish the necessary procedures to meet the standards that currently exist. The value created by developing a robust quality system and obtaining FDA clearance creates a huge market differentiation and provides distinction from scores of other similar software applications. Although pre-market submission and implementing a quality system seem like an overwhelming task, they should be viewed positively, as process to provide a better and safer product as well as a barrier to entry for other competitors. The required procedures and documentation that are expected of a medical device company will not change with any guidance publication.
By complying and operating under Quality System Regulations (similar to Quality System Standards such as ISO 9001 or ISO 13485), companies ensure that software design, development, and initial release or modifications follow a strict set of rules (i.e. design controls). In a company with the required quality system, consumers know that software is thoroughly tested and validated to ensure it performs the way the company claims. Unregulated apps or those that have not implemented quality system procedures do not provide the same assurance and pose tremendous risk of error, malfunction, security breach, and harm to the patient/consumer based on false claims and uncontrolled development environments.
Regulation shouldn’t be avoided, it should be taken head on by mobile health companies because it creates a strong reassurance to customers and medical professionals that your product is safe and effective and performs as intended. With the growing number of health apps available, there is no standard evaluation criteria or an effective way to determine which apps perform to meet the user requirements and achieving a clearance will provide a clear distinction from wellness and fitness app to clinical grade medical device.
The process of applying to the FDA for mobile health companies typically falls under a 510(k) application. This process will help the mobile health company and the FDA determine information such as indications for use and all claims of intended use (health related), description of the device, detailed technical and design descriptions, descriptions of device testing (verification and validation, which often includes clinical and/or patient/user studies). The official clearance letter from the FDA that states a product is “cleared by the FDA” (not approved) ensures that the device has been thoroughly reviewed and was determined to be safe and effective.
The FDA (or international equivalent) clearance letter is the gold standard for mobile health companies and should be a requirement of any company that provides a tool to assist in the management, assessment or treatment in a medical condition. The issuance of a guidance letter will do nothing at all to change this fact. The true value of the FDA’s Final Guidance is improved clarity for what is expected of a submission to reduce the time it takes for the FDA to review and respond or provide clearance. The issue of the amount of time it takes to get a response on a submission should be the focus on further clarification provided by the FDA, but it should not be construed as a declaration of new requirements.
