Monthly Archives: September 2022

Unpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on Imports

A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region.  Such a government initiative would significantly deter investments in the companies doing the importing.  Turns out, the agency was not.  The FDA’s recent activities in the region were well within their historical norms.

But the project got us thinking, what does the agency’s enormous database on import actions tell us about the agency’s enforcement priorities more generally?  There are literally thousands of ways to slice and dice the import data set for insights, but we picked just one as an example.  We wanted to assess, globally, over the last 20 years, in which therapeutic areas has FDA been enforcing the 510(k) requirement most often?

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ILN Today Post

Llinks Bulletin: China Issued Application Guidance for Data Export Security Assessment: Impact on Multinational Business

On late Aug 31st 2022, the Cyberspace Administration of China(“CAC”) promulgated the first edition of the Application Guidance for Data Export Security Assessment (the “Guidance”). Being released just ahead of the Assessment Measures of Data Export Security Assessment (the “CAC Assessment Measures”) becoming effective, the Guidance provides for the manners, procedures and documentations required for a data export security assessment under the CAC Assessment Measure (the “CAC Assessment”).   Read more…

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Law Firm ILN-telligence Podcast | Martino Canal, Ferrari Pedeferri Boni Studio Legale Associato

Martino Canal is a labor partner at Ferrari Pedeferri Boni Studio Legale Associato in Milan, Italy, which is also a member of the International Lawyers Network. In this episode, Lindsay and Martino cover the importance of adaptability and communication, the balance between innovation and privacy, and the value of humanity mixed with professionalism. And don’t miss finding out Martino’s secret identity!

You can listen to the podcast here, or we’ve provided a transcript of the highlights below.
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ILN Today Post

Torres Talks Trade Podcast Episode 13 When Government Agencies Come Knocking

In the second of a two-part series regarding the BIS Office of Export Enforcement, host Olga Torres sits down with former BIS Special Agents Don Pearce and Jim Fuller to discuss what to do when government enforcement agencies come knocking, and how to interact with the government if there’s a VSD or an ongoing investigation

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Podcast: Owner’s Outlook: Maximize and Safeguard Reimbursement Through Design – Diagnosing Health Care

Now on the Diagnosing Health Care Podcast:  The COVID-19 pandemic kicked off a pivot in health care construction and design, and acute care facilities have been rapidly renovating to adapt their spaces to evolving public health care needs.

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Tesla Gets a Dressing Down by the NLRB

On August 29, 2022, the National Labor Relations Board (“NLRB” or the “Board”) issued a decision in Tesla, Inc. regarding dress code policies that further the Biden Board’s efforts to remake NLRB policy. This decision has big implications for employers that maintain appearance, dress code, and uniform policies. The Board’s decision now firmly establishes that any employer’s uniform or dress code policy is inherently unlawful if it can be read “in any way” to prohibit employees from wearing union insignia unless an employer can prove that its policy is justified by special circumstances. It is irrelevant whether the employer’s policy has ever been applied to prohibit union t-shirts or the employer actively permits union buttons or other insignia. Further, and critical to a broader understanding of the implications of this decision, it is also irrelevant whether the workplace is unionized or even being actively unionized.

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