Regulatory & Reimbursement Update

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across [...]

According to the most recent "U.S. Product Safety And Recall Index" report by Sedgwick, manufacturing defects are the leading cause for product recalls in 2023 through the month of March.

Read about AAMI and BSI partner is to publish guidance on artificial intelligence and reimbursement lags for prescription digital therapeutics.

Read about the FDA-issued Marketing Submission Recommendations and the new rules the EPA has proposed for medical device sterilization.

Regulatory Ready or Not, Here Comes Medical Device Cybersecurity Legislation Late last year, President Joe Biden signed a $1.7 trillion omnibus appropriations bill into law, which included [...]

Regulatory, IMDRF guidance aims to harmonize, streamline review reports. The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory [...]

Regulatory, FDA final rule reduces radiological devices reporting requirements. FDA announced a final rule on 20 January that amends and repeals some radiological health regulations for radiation [...]

Regulatory, MDR: MDCG offers workaround for legacy devices with expiring certificates. MDCG said for manufacturers that have made “reasonable efforts” to comply with MDR, competent authorities [...]

Regulatory, FDA clarifies definition of devices vs. counterfeit devices. FDA has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act.

Regulatory FDA launches TAP Pilot to speed access to safe and innovative medical devices The FDA has launched the TAP Pilot Program (Total Product Life Cycle Advisory Program) for manufacturers [...]