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 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 [...]

New legislation would mandate all ISOs register with FDA

IAMERS Counsel Robert Kerwin to appear on May 2, 2017 before the U.S. House of Representatives Committee on Energy and Commerce on the Legislation. On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed H.R. 2118 seeking to require registration of [...]

By |2017-04-28T06:46:04+00:00April 28th, 2017|Government, Legal Advice, Reform, Regulatory|0 Comments

Know Your Shipping Terms – Similarly Named Shipping Terms Mean Different Things in Different Countries

Many of the shipping terms in a contract for the sale of goods, have special significance under applicable law. The shipping terms assign the parties certain rights and obligations with regard to who will bear the cost of shipping and who must bear the risk of loss. However, important shipping terms mean different things in [...]

By |2013-06-05T13:57:23+00:00June 5th, 2013|Business, Government, Legal Advice|1 Comment

Medical Device Excise Tax

Preliminary Note: In 2010 the Medical Device Excise Tax law was enacted. The IRS issued two weeks ago a forty page preamble and eighteen pages of regulations with respect to its scope and implementation. 26 C.F.R. Part 48. The IRS also issued a ten page guidance document. This compilation is based on the IRS preamble, regulations and guidance document issued [...]

By |2012-12-21T12:10:25+00:00December 21st, 2012|Government, Legal Advice, Used Medical Equipment|2 Comments

Overview on Incoterms/CISG and Why They Are Important to International Business

by: Robert Kerwin Fifty nine countries worldwide, including France, China and the United States,[1] are signatories to the U.N. Convention on Contract for the International Sale of Goods (“CISG”). The purpose of the CISG is to bring uniformity to international business transactions principally with respect to commonly used trade terms. If you live and work [...]

By |2012-07-10T17:59:05+00:00July 10th, 2012|Business, Legal Advice|0 Comments

Caveat Emptor: Know Your International Business Partner

by: Robert Kerwin With the worldwide rise in ferreting out bribery and global corruption, it is never more important to really know your business partner. The risk of ‘not’ knowing with whom you are dealing in business may include being exposed to situations potentially violative of the U.S. Foreign Corrupt Practices Act (“FCPA”). This admonition [...]

By |2012-07-10T17:41:28+00:00July 10th, 2012|Business, Legal Advice|0 Comments
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