The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS wraps up prior authorization rule; ITC finds no violation of Section 337.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Motus GI, Sml Genetree.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, DBV, Gracell, Pfizer, RDIF, Steba.
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. saw its shares rise 27% on the heels of its first U.S. approval for its collagen medical device for dental guided bone and soft tissue regeneration applications. “It’s an important milestone for us, and one that came quicker than I was expecting it to come,” Orthocell CEO Paul Anderson told BioWorld. The company submitted its 510(k) application to the FDA in May, and he was expecting approval by the middle of 2021.
The Medicare Coverage of Innovative Technology (MCIT) program drew rave reviews when it was unveiled, but the associated proposal to redefine the term “reasonable and necessary” met with skepticism. The final rule includes some discussion of how private payer coverage might be leveraged to broaden the definition, but the Centers for Medicare & Medicaid Services (CMS) nonetheless punted on the question for now, promising to tackle it within a year.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
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