Health care is of great importance to society and its market value. It is also an area that large and small technology companies want to cut into. But because health care matters a lot, often the pre-certification of a product or service takes a long time. As a result, the US Food and Drug Administration (FDA) announced the launch of a pilot program called the FDA Pre-cert, hoping to set more appropriate specifications to accelerate health technology innovation and time-to-market.
FDA initiates reforms to accelerate medical innovation
There are many regulations in the health care industry. It often takes at least several months or even longer for new products to go public, which hinders the innovation and development of digital technology in the field of health care. Perhaps the most famous example in the past was that 23andMe, a well-known genetic testing company in the United States, was asked by the FDA to suspend the promotion and sale of health analysis products in 2013. It was not until FDA certification in April this year that it was approved to be accompanied by a doctor. Do your own genetic testing.
23andMe received FDA certification this year. (Source:23andMe)
“We need a modern regulatory framework.†The FDA director, Scott Gottlieb, who took office in May this year, hosted the AdvaMed MedTech conference in California, announcing the launch of the FDA Pre-cert to accelerate health technology development. The Pilot Program hopes to find better ways to build more flexible and more appropriate specifications for health technology. The FDA says this will help the digital health reforms in the United States.
9 companies including Apple and Samsung were selected for the pilot program
At the same time, Gottlieb also announced that it has selected nine companies from more than 100 applicants to participate in the program, namely, Apple, Fitbit, Johnson & Johnson, Roche and Samsung. And startups such as Pear Therapeutics, Phosphorus, Tidepool and Verily. Among them, Verily was the life science team of Google X Lab. It has released contact lenses that can measure blood sugar, and then became a company under the name of Verily. Now it is also a member of Alphabet.
The FDA press release specifically emphasizes that this program is not primarily targeted at individual products, with a focus on developers. However, it is believed that for the 9 companies selected, the election to participate in this program is equivalent to the opportunity to participate in setting the relevant health technology specifications in the United States, which is conducive to the early development of the future development.
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