Regulatory & Reimbursement Update

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 [...]

Regulatory FDA issues final rule removing certain software from medical device regulations  The US FDA has issued a final rulemaking that eliminates certain software intended to [...]

Regulatory Device, digital health firms oppose HHS’ proposed 510(k) exemptions  Medical device and digital health companies have largely come out in opposition to a proposal from the Department [...]

Regulatory UK passes post-Brexit medical device regulatory bill into law The cornerstone of the UK’s post-Brexit medical device regulatory system, the Medicines and Medical Devices Act 2021, [...]

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.

A new digital health Center of Excellence within the FDA aims to boost digital health innovation by fostering partnerships and connections among digital health stakeholders.