The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA taking adcomm nominations; HHS, DoD ink deal with Cue Health; NTAP town hall set for Dec. 15-16.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cefaly Technology, Crossbay Medical, Fh Ortho, Immersivetouch, Micro Medical Solutions, Sonivie.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Medicare overpaid for facet-joint injections; FDA posts IIE policy for non-COVID tests.
The U.S. FDA has several years of experience with computational modeling (CM) for medical device design and testing; however, the movement toward a policy has wanted for a solid body of data on which to base a guidance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Cartiheal, GE Healthcare, Varian.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation; AMA adds codes for COVID-influenza testing; MedPAC concerned about post-pandemic telehealth; CMS: CLIA audits yield cease-and-desist letters.
Several senior managers at the Center for Devices and Radiological Health (CDRH) have been pushing the convergence between U.S. FDA and international quality systems standards, often with the claim that the two standards already are nearly completely aligned. However, Jack Garvey, CEO of Compliance Architects LLC, ran through a side-by-side comparison of ISO 13485 and Part 820 and maintained that the two standards are too conceptually and textually different to plausibly assert that they are 95% harmonized.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Genmark Diagnostics, Oxford Nanopore.
There are some U.S. FDA work items that have been hampered primarily by the COVID-19 pandemic, and some that have just proven difficult to push across the finish line. The FDA’s October 2018 draft guidance for premarket considerations for cybersecurity in medical devices might fall into that latter category, but the FDA’s Suzanne Schwartz said the agency will reissue another draft version of that guidance, which will be available sometime in early 2021.
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