FDA vows to develop an efficient regulatory framework for mobile medical apps
FDA is working with the different organizations to build a regulatory framework that is needed to safeguard mobile health apps market by working on an updated model of the pilot program.
In a 2nd July viewpoint in JAMA a top official of FDA stated that government authorities and healthcare can’t maintain the innovation level in the digital healthcare sector and opined that the innovations happening in digital healthcare space needed to be promoted and worked upon in a more intensive manner.
FDA, the Food and Drug Administration works for protecting and providing public health. It is responsible for maintaining the health level by supervision and control over dietary supplements, food, tobacco products, medications, vaccines and others. FDA nowadays is promoting digital health through Software as a Medical Device (SaMD) and they have been working on an updated working model which they expect to be finished by the end of the year.
In this pilot program, a total of nine companies have been working together to achieve the goal. Companies such as Johnson &Johnson, Apple, Fitbit and a few others were decided to contribute to the project, which is supposed to start next year.
Top officials of FDA said that it is important to create a regulatory framework for digital healthcare providing through SaMD that serves in various aspects of healthcare. This is to meet the ultimate mission of protecting and promoting public health through digital healthcare. This is to do in all the field of healthcare such as clinical descriptions, a user interface for unique identification, economical aspects, introduction, and modifications of new products.
They added that the old applications of FDA’s regulatory framework need new safeguards for the patients. That is one of the main reasons for a new regulatory framework.
A Digital Health Innovation Plan focused on smooth-running the track of digital healthcare devices was released by Gottlieb in the last June. The plan was also build to straight line the agency’s contribution in mobile apps for healthcare.
The main focus of the plan is a pilot program which will allow low-risk software-based medical devices developers to self-clarify their products and can prevent usual review procedures about their products.
The agency equipped an enlightenment in December stating that they will regulate various types of patient and clinical decision advisory software as medical devices. International Device Regulator Forum will also be providing their guidance in developing SaMD. In January, FDA stated some of their digital health goals for the year 2018. Development of PreCert pilot program was among the spotlight. Also, finding new digital methods for laboratory development tests was also on the list.
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