Plagiocephaly Device First To Avoid Class III Status Via FDAMA Provision
This article was originally published in The Gray Sheet
Cranial orthosis devices intended to treat severe non-synostotic positional plagiocephaly in infants three to 18 months of age are the first generic device type to avoid default Class III status via Sec. 207 of the FDA Modernization Act.
You may also be interested in...
Visible Genetics, Inc. plans to submit a petition to FDA by August seeking classification of its Trugene HIV-1 genotyping test and OpenGene DNA sequencing system as Class II following FDA's rejection of a September 2000 510(k) submission.
The US is to ship only half of doses for Pfizer, Moderna COVID-19 vaccines in the first instance, while Rhizen Pharmaceuticals starts a Phase I trial of a DHODH inhibitor.