Info and News

Cost of Non-Compliance Rise: FCC Fines Adjusted for Inflation

The Federal Communications Commission has amended its rules to increase the maximum fines (“monetary forfeiture penalties”) it can levy for violations of its rules. The amendment to Section 1.80(b) of the FCC rules is authorized by the Federal Law, in the form of the “Debt Collection Improvement Act of 1996,” 28 U. S. C § 2461, which requires federal agencies to adjust their maximum civil penalties for inflation at least once in every four years.

The new maximum amounts fall into three classes:

For broadcasters and cable operators: $32,500 per violation or per day of a continuing violation, with a maximum per continuing violation of $325,000;
For common carriers: $130,000 per violation or per day of a continuing violation, with a maximum amount per violation of $1.325 million; and
For others (including equipment manufacturers and marketers): $11,000 per violation or per day of a continuing violation, with a maximum per continuing violation of $97,500.

This action does not affect the “base” forfeiture amounts specified in Section 1.80(b)(4) of the FCC rules. These set the starting points for forfeiture levels, which may be adjusted upwards or downwards depending on such factors as the severity of the problem, prior history, and efforts to mitigate the problem. For example, the “base” fine for interference (per violation per day) is $7,000, while for use of unauthorized equipment it is $5,000.

EU Commission Designates Standards for Medical Device Directive

On June 24, 2004, The European Commission published its most recent update of the harmonized standards designated for assessing compliance under the Medical Devices Directive, 93/42/EEC. This Directive is part of the New Approach series of directives. Under the New Approach, a common “CE” mark is applies to indicate compliance with all directives applying to a given product.

For New Approach directives, standards are not written into the text of the directives, but are instead subject to ongoing selection and revision. Standards become effective when “designated” by the Commission, which means when notice is given of their selection through publication in the Official Journal of the European Union.

The current set of designations for 93/42/EEC spans eleven pages. Approximately 75% of the entries concern updates for general “-1-x” and device specific “-2-x” standards which are part of the EN 60601 family. The EN 60601 group of standards comprises a group which as a whole addresses the safety of medical electrical equipment.

These standards are divided into two subgroups. “Part 1” standards, bearing the numbers EN 60601-1-x, contain requirements for multiple types of medical equipments. For example, EN 60601-1-1 concerns general electrical safety, and EN 60601-1-2 concerns electromagnetic compatibility. “Part 2” standards contain additional requirements applicable to specific types of equipment. For example, EN 60601-2-19 applies to baby incubators.

Manufacturers should be aware that several of the older versions of the “Part 1” standards have been updated, and the older versions have either expired, or are expiring in the near future. Equipment should be assessed to current versions of the standards to maintain conformity with the Directive’s safety requirements. In addition, a significant number of new “Part 2” device-specific standards have been added to the list. These will add specific requirements for a number of types of equipment.

In addition to the EN 60601 safety standards additions and revisions, a number of other new equipment performance standards have been introduced in the Commission’s publication.

Barbie, Ken, and Blaine: The Latest

And now for something light: We recently reported that Mattel’s Barbie—yes, the doll—left her long time beau, Ken, after being romantically linked with him for over 40 years. Speculation concerning her motives abounded. Was Ken just too straight? Was it just time for a change? Was Barbie’s head turned by the hipper Blaine, Mattel’s new Australian surfer doll?

Unlike real-life breakups, the public got to vote on who Ken’s replacement should be. Over 2 million votes were tallied at Barbie’s website (www.barbie.com), and Blaine won in a landslide. You can find a picture of the happy couple at:

http://barbie.everythinggirl.com/activities/party/datingfun/.

There’s one other piece of Barbie-related news that’s crossed our desk. Recently, a U. S. District Court ruled that Mattel had to pay more than $1.8 million in legal costs to a Utah man who incorporated photos of nude Barbie dolls in his artwork. In 1999, Mattel sued artist Tom Forsythe of Kanab, Utah, on the grounds that his use of Barbie infringed Mattel’s toy copyrights and intellectual property.

The legal fees mounted, but the Court held that it was a matter of free speech, and that Forsythe’s parody of the famous Barbie was protected by the First Amendment. It also said that Mattel’s suit “may have been groundless and unreasonable.” Mattel appealed and lost, and was ordered to pay costs.

This is all very interesting, but--inquiring minds have to wonder if Barbie’s risqué modeling might have been the REAL reason behind her breakup with Ken.

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