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 electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]
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 to the guidance has been extended to September 22, 2021. In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]
By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on the U.K.’s continued membership in the European Union. In June 2016, the citizens of the U.K. voted to leave the EU. In January 2020, the U.K. officially withdrew, and since that time the EU and the [...]
By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]
An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]
May 13, 2020 By Robert J. Kerwin This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51199 In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 [...]
IAMERS CONTINUES TO ADVOCATE AS THE FDA SERVICING DEBATE RAGES ON DESPITE THE FDA REPORT RECOMMENDING NO NEW REGULATIONS
With rumors of a possible renewed push for Congressional legislation, IAMERS president Diana Upton and general counsel Robert Kerwin attended the AAMI Annual Meeting during the first week of June 2018. Their attendance is part of IAMERS’ efforts to reduce the fear-mongering and to get out the message of independent servicers for safe patient oriented [...]
Shortly before the summer congressional recess, the U.S. Senate passed a bipartisan bill to reauthorize the FDA user fee programs. The Senate User Fee bill followed the House bill and was approved 94-1. President Trump’s spokesperson has announced that the president will sign the bill. See the full story at DOTmed by clicking here.
Read the AAMI article here.