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The Food and Drug Administration (FDA) instituted a program to pre-certify tech companies which have a proven track record in digital health tech developments. Called the Digital Health Innovation Action Plan, this bold idea was introduced in July, and the program started evaluating companies in August for the PreCert for the program.

Pre-Certification Pilot Program Results

The Digital Health Innovation Action Plan aims to streamline the process for approving software-based medical software and devices. Part of the plan would also help modernize the process used to approve drugs and other more complex medical equipment.

A streamlined FDA procedure can shorten the time to accredit a drug. Drug trials typically take several years, but this may be quicker in the future if the same methods to shorten the acceptance of devices become a standard.

There were more than 100 digital health tech companies that applied in August for the pre-certification program. After extensive evaluation, the list was cut down to nine companies. One of the criteria for inclusion in the pilot program is that the company has to have a proven track record in designing and developing quality health care devices.

Included in the pilot program were Johnson & Johnson, Roche Holding AG, Apple Inc., Samsung, Verily Life Sciences (a division of Alphabet Inc.), Fitbit, and startup companies Pear Therapeutics, Phosphorus, and Tidepool.

Verily, a subsidiary of Google’s parent company Alphabet, has been developing a slew of health tech applications including the Debug Project, where they release male mosquitoes which have been infected with the Wolbachia bacteria. The male mosquitoes look and act normal; however, when they mate, the female mosquitoes lay eggs which don’t hatch.

Apple has also been busy in the digital health tech space. They are currently developing a wearable which can be used to monitor the blood glucose level without pricking the skin. In addition, they also did a study where an Apple Watch app could detect a serious heart problem with a highly significant level of confidence.

Keeping Up with Tech

In recent years, digital health has grown by leaps and bounds, and the FDA has not been able to keep up. One example is a deoxyribonucleic acid (DNA) testing kit by 23andMe which was only recently approved – it was previously flagged by the FDA. The FDA has acknowledged that there is a problem they need to address. Aside from the programs above, they also determined that devices like fitness tracker wearables are no longer be subject to regulation.

A streamlined FDA procedure can shorten the time to accredit a drug. Drug trials typically take several years, but this may be quicker in the future if the same methods to shorten the acceptance of devices become a standard. FDA pre-certification of companies would help with set quality guidelines, key performance indicators, and demonstration of a culture of excellence within the company. Not only are companies expected to pass the initial screening based on their history in research and development, but they are also expected to maintain these high standards for years to come. This emphasis on quality and maintaining high standards for products help ensure that the research will meet FDA standards, and that the agency in return would no longer need to double check on them because of the continuing quality assurance already present within the companies.

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