Regulatory & Reimbursement Update

Regulatory US FDA’s latest medical device cybersecurity guidance: Key differences from previous versions On April 8, 2022, the US Food and Drug Administration published a new draft [...]

Regulatory MDUFA V: US FDA sets performance goals for De Novo medical device reviews MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 [...]

Regulatory US FDA formally proposes aligning Quality System Regulations with ISO 13485 The US Food and Drug Administration has published a highly anticipated proposed rule to harmonize its [...]

Regulatory FDA misses MDUFA V deadline after months of contentious talks FDA has failed to send the final Medical Device User Fee Amendments V agreement to Congress by the Jan. 15 deadline. The [...]

Regulatory  FDA expands eSTAR filing to de novo devices, IVDs US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to [...]

Regulatory FDA issues draft guidance for device software in premarket submissions The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about [...]

Regulatory FDA nixes GUDID submission requirements for class I consumer healthcare devices Manufacturers of class I medical devices considered to be consumer healthcare products will get a [...]

Regulatory FDA issues draft guidance on electronic 510(k) submissions The US Food and Drug Administration (FDA) issued a draft guidance to assist sponsors in using an electronic template for [...]

Regulatory FDA seeks more power for medical device cybersecurity mandates FDA is seeking “additional legislative authorities” meant to bolster medical device cybersecurity amid [...]

Regulatory US FDA rolls out final guidance on Unique Device Identifier (UDI) labeling requirements The FDA has published its long-awaited final guidance on form and content requirements for [...]