moose_ears

6 ms·

1. 1.▲
   by moose_ears 4y ago

   It is true that prescription (Rx) and over the counter (OTC) devices have different requirements, particularly with respect to the instructions for use, and many companies choose to pursue Rx first before expanding to OTC down the line beca
2. 2.▲
   by moose_ears 4y ago

   This topic is addressed by Grady Hannah, co-founder and CEO of NightWare, on the June 23 edition of the DTx podcast with Eugene Borukhovich. FDA posted a PDF summary of its decision on this product here: https://www.accessdata.fd
3. 3.▲
   MedCon: Industry praises FDA’s digital health Pre-Cert pilot(raps.org)

   1 points by moose_ears 4y ago|0 comments
4. 4.▲
   by moose_ears 6y ago

   Related: https://open.fda.gov/apis/device/covid19serology/