We have been hearing, for some time, rumors that powerful medical device manufacturers’ trade organizations were going to push Congress to tack onto the FDA User Fee Legislation new definitions of remanufacturing, which would redefine "remanufacturing" in a way likely to impact medical device servicing in a substantial way. All early signs pointed to this [...]
In its continued efforts to harmonize with international regulatory authorities, the U.S. Food & Drug Administration has an nounced its intention to amend the current good manufacturing practice requirements of the FDA quality system regulation, 21 C.F.R 820 et seq. to align more closely with the international consensus standard for devices, ISO 13485. This is [...]
An op-ed by Robert J. Kerwin As the 2021 Federal Trade Commission (FTC) report to Congress on repair restrictions acknowledged, some medical equipment manufacturers are limiting the availability of diagnostic software and firmware necessary to make repairs. That situation may soon worsen, if legislation proposed by a manufacturer trade association is filed and approved. This [...]
We are excited to announce the publication of the latest IAMERS Who's Who. Click here to read the latest issue.
At the annual IAMERS educational meeting in Chicago last week, IAMERS took a deep dive on vendor management trends and best practices with two seasoned industry veterans. Intermountain Healthcare's director of clinical engineering, Michael Powers, and Crothall Technical Resources' vice president, Sheila O’Donnell, presented on 2022 best practices. The 90-minute discussion drilled down about the [...]
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 use of electronic medical device equipment manuals by servicers. Today, the Librarian of Congress issued a ruling to accept for the next three years the recommendation of the [...]
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 [...]
On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]
By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices. The 17-page document contains two appendices of examples and addresses both devices and software. The draft guidance, which does not apply to single-use devices and is not intended to include significant policy changes, aims to [...]
