Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals
Two months ago, a little-known rulemaking proceeding was underway at the U.S. Copyright Office which, depending upon the outcome, was poised to have favorable implications for the [...]
FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns
A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of [...]
FDA Remanufacturing Guidance Comment Period Extended
On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments [...]
16th IAMERS European Meeting – CANCELED
Cancelled Due to COVID-19 Restrictions The 16th IAMERS European Meeting. Amsterdam, 15th – 17th September 2021 [...]
Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’
On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In [...]
FDA Service and Remanufacturing Draft Guidance: Key Takeaways
By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing [...]
IAMERS Who’s Who
IAMERS is a trade association whose members are world-class providers of pre-owned medical imaging systems, parts and [...]
Brexit agreement begins now: Are you ready?
By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a [...]
FDA adverse event reporting form to include question as to third-party service
By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to [...]