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Medical Devices › OEM

Arnall Golden Gregory LLP

Every Little One, Every Little One: FDA Issues a Warning Letter to a Medical Device Reprocessor for Changes to Marketed Products

Arnall Golden Gregory LLP on

“Every little one, every little one,” a song lyric from Bruce Hornsby and the Range’s 1986 single, “Every Little Kiss,” comes to mind when we read a recent Food and Drug Administration Warning Letter issued to a reprocessor...more

Stinson LLP

Medical Device Third-Party Servicers: Will FDA Treat You as a Manufacturer?

Stinson LLP on

Recently, in response to requests by stakeholders, FDA extended the deadline for comments to its draft guidance "Remanufacturing of Medical Devices," which provides the agency's current thinking regarding the distinction...more

Hogan Lovells

“Remanufacturing” or “Servicing”? New FDA guidance clarifies distinction for medical devices

Hogan Lovells on

On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when manipulation or repair of a medical device becomes...more

Mintz - Health Care Viewpoints

How Much Control Do Device Manufacturers Have Over Servicing?

Mintz - Health Care Viewpoints on

In December, my colleague Aaron Josephson and I described our observations after attending FDA’s public workshop on Medical Device Servicing and Remanufacturing Activities. In this post, I want to share some additional...more

Hogan Lovells

The MHRA issues new guidance concerning Own Brand Labelling or "Virtual Manufacturing"

Hogan Lovells on

On 29 March 2017, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new guidance (hereafter “Guidance“) concerning the Own Brand Labelling of medical devices in the United Kingdom. The Guidance,...more

Mintz - Health Care Viewpoints

FDA Still Seeking Manufacturer Views on Medical Device ISO Regulation

Mintz - Health Care Viewpoints on

On March 4, 2016, the FDA issued notice in the Federal Register that it had opened a docket to accept comments on the agency’s proposed plan to address the refurbishing, remarketing, rebuilding, remanufacturing, and servicing...more

Knobbe Martens

Greatbatch, Inc. Completes $1.73 Billion Acquisition

Knobbe Martens on

Greatbatch, Inc. recently announced that it has acquired Lake Region Medical (previously known as Accellent Inc.) pursuant to a deal valued at about $1.73 billion.  Reuters reports that Greatbatch will pay $478 million in...more

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