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FDA Draft Guidance Clarifies Rules Of Summary Reporting Program

 
• By Elizabeth Orr

The program allows manufacturers of most lower-risk devices to submit reports of known adverse events via quarterly summaries, rather than individually.

Digital representation of a networked server room.
• Source: Shutterstock

The US Food and Drug Administration has released a new set of recommendations intended to help eligible manufacturers use the Voluntary Malfunction Summary Reporting (VMSR) program to notify the agency about device malfunctions.

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More from Compliance

New CLIA Rule Updates Personnel Policies

 
• By Elizabeth Orr

A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.

Chevron Law Firm Asks Court To Delay CPSC Rule On Infant Loungers

 
• By Elizabeth Orr

The New Civil Liberties Alliance, which represented a plaintiff in the lawsuit last summer that ended court deference to federal agencies, is asking for a stay on the consumer protection agency’s rule on infant support cushions. The law firm argues that CPSC wrongly used an expedited process to issue the rule.

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 
• By Brian Bossetta

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.