Insights into the middle market.

  • Non-Immigrant Visa Updates: USCIS Completes H-1B Lottery Selections; After Long Wait, E-2 Visas for Israeli Investors to Become Available
    April 22, 2019

    Updated news from USCIS this spring includes final H-1B lottery selection news and a boon for Israeli investors who will be eligible to apply for E-2 treaty investor visas at the U.S. Embassy in Tel Aviv.

  • FDA’s Safety and Performance Based Pathway Guidance Expands Abbreviated 510(k) for Certain Device Types
    April 15, 2019

    There are three types of Premarket Notification 510(k)s that may be submitted to the U.S. Food & Drug Administration (FDA): Under the recently finalized Safety and Performance Based Pathway guidance, FDA has expanded the Abbreviated 510(k) route for certain well understood device types. The FDA expects to begin implementation of this pathway as soon as the device types and performance criteria are identified. Once implemented, a medical device manufacturer will be able to use performance criteria instead of direct comparisons to show substantial equivalence for qualifying devices.

  • Across the Atlantic: Strategic Considerations for Holders of IP Rights
    April 12, 2019

    The news cycle is filled with the raucous activity of the UK Parliament with regard to Brexit, the "exit" of the UK from the European Union. On March 29, even Theresa May's offer to resign did not persuade Parliament to approve of the Withdrawal Agreement. As of yesterday, Brexit Day has moved to October 31, 2019, but the EU's extension obligates the UK to vote in parliamentary elections in May (or Brexit Day will be June 1). The EU will convene a summit in June to review the UK's progress towards Brexit.

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