According to Bloomberg, the Food and Drug Administration has announced the names of nine companies participating in a pilot program that could let them pre-clear products instead of going through the agency’s traditional application process.
The program, called Pre-cert, will include Apple, Fitbit, Samsung, Alphabet-owned Verily, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, and Tidepool. The program had attracted over 100 interested companies, and the FDA made its selections based on factors like company size and risk profile of the product(s).
The FDA’s usual timeline for approving new products can often take months, which can delay developers as tech advances faster than the agency can approve it. “We need to modernize our...
from
https://www.theverge.com/tech/2017/9/26/16369212/fda-pre-cert-program-apple-fitbit-health-tech
from
http://ifeeltechinc.blogspot.com/2017/09/apple-and-fitbit-join-pilot-program-to.html
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