FDA grants Active Implants a breakthrough device designation for the NUsurface Meniscus Implant.
FDA clears a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition imaging.
FDA releases its long-awaited Technology Modernization Action Plan that describes short-term actions it is taking to modernize technology use.
CDER issues a MAPP with policies and procedures for product development and pre-submission meetings with potential ANDA applicants.
FDA finalizes a guidance on drug-related citizen petitions and petitions for stay of action.
Federal Register notice: FDA seeks comments on an information collection extension for drug/biologic postmarketing studies status reports.
CDRH introduces its STeP safer technologies program.
FDA grants an orphan drug designation for its novel gene therapy for treating the CEP290 mutation associated retinal disease.