The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
A recent UK Supreme Court Judgment, the Financial Conduct Authority v Arch Insurance (UK Ltd) & Ors [2021] UKSC 1, clarified whether a variety of insurance policy wordings cover business interruption losses resulting from the COVID-19 pandemic and public health measures taken by UK authorities in response to the pandemic from March 2020 ...
On 24 December 2020 the United Kingdom (UK) and the EU entered into the UK-EU Trade and Cooperation Agreement (TCA) which will govern the relationship between the UK and the EU as of 1 January 2021. Tax consequences VAT European VAT is governed by the VAT Directive and case law by the Court of Justice of the European Union (CJEU). As a result of the Brexit the UK is now considered a third country and no longer bound by these sources ...
The owners of multistate businesses must consider many factors when deciding how to structure their business ventures, and state taxation should not be overlooked. The accompanying tables can assist in that evaluation for limited liability companies and limited liability partnerships. In recent years, LLCs and, to a lesser extent, limited partnerships and LLPs have become the popular choice for structuring or restructuring multistate business entities ...
On 14 January 2021, the Ministry of Economy and Finance issued Prakas No. 010 on “the Local Manufacturers Obligation to place devices for measuring the volume of beer and non-alcoholic drinks” (“Prakas 010”). The purpose of Prakas 010 is to establish rules and procedures for managing the use of devices which measure the volume of beer, and/or non-alcoholic beverages that are produced locally ...
In December 2020, the National Institute of Industrial Property (INPI) published on its portal the Examination Guidelines for Inventions Implemented by Computer Program ...
Early last year the Prime Minister dropped the “E-bomb” on British motorists, announcing a ban on cars powered wholly by petrol and diesel from 2030, and on the sale of new hybrid vehicles with the capability to drive a significant distance with zero emissions (such as plug-in or full hybrids) from 2035. Since then, the COVID-19 pandemic has impacted the world in an unprecedented manner ...
On February 1, 2021, the Federal Trade Commission (FTC) announced its revised annual threshold that determines whether companies may be required to notify federal antitrust authorities about a proposed merger or acquisition due to the size and value of the transaction. For the first time since 2010 and a reflection of the state of the economy, the annual threshold has been reduced rather than raised, from $94 million in 2020 to $92 million for 2021 ...
On January 25, 2021, the German federal Cabinet introduced the draft for the new Cyber Security Act (“IT Security Act 2.0”) into the legislative process ( Draft of a Second Act to Increase the Security of Information Technology Systems, printed matter 19/26106 [draft of a second law to increase the security of information technology systems, document 19/26106] ). The new German Cyber Security Act is intended to replace the old German Cyber Security Act of July 2015 ...
The Oil Can published an article by Dinsmore partner Mark Boos this week in its Spring 2021 edition about the importance of indemnification provisions are essential in commercial contracts, an excerpt of which is below. Indemnification provisions are part of virtually every commercial contract. Ironically, they’re also among the contract elements most likely to be overlooked by the parties ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The “right to be forgotten” (“RTBF”) has been central to the global debate over the balance between individual privacy and freedom of information and of the media in recent years. Such right has been affirmed by the European Court of Justice in a milestone case in 2014, as well as later in the UK, although its application in other countries remains uncertain ...
The 2021 tax assessment of real and personal property will be determined by local Assessors in February, at which time a Notice of Assessment will be issued and mailed to property owners. Property owners should make sure to check the mail for a copy of the Notice in order to determine whether an appeal of their taxable value should be filed ...
Aron Beezley of Bradley Arant Boult Cummings LLP enumerates the key impacts of the Federal Acquisition Regulation Council's final rule adopting mandates of the executive order Maximizing Use of American-Made Goods, Products, and Materials. The Federal Acquisition Regulation (FAR) Council recently issued a final rule1 that implements the requirements of the Maximizing Use of American-Made Goods, Products, and Materials Executive Order ...
Pursuant to the Prevention and Suppression of Money Laundering Activities Law (the “AML Law”), which transposes into national legislation the 4thEU AML Directive ((EU) 2015/849), companies and other legal entities must maintain and register, in a central public register to be created for this purpose, information on their beneficial owners ...
Operation hours of IRB Counters during Movement Control Order (“MCO”), Conditional MCO & Recovery MCO periodThe Inland Revenue Board (“IRB”) has issued a media statement on the operation hours of its counters during the MCO, Conditional MCO and Recovery MCO period. For more information, please click here ...
The introduction of mandatory pre-installation of applications developed by Russian market players, caused by a wave of cases of abuse by global companies of their dominant position in digital markets, is a significant innovation in Russian antitrust and consumer protection law. To reduce the risks of restricting competition and balance the bargaining power of global corporations with small domestic application developers, amendments to the Law dated February 7th 1992 No ...
We would like to inform you that several laws, that will have a significant impact on IT and data protection regulation, were adopted at the end of 2020 (“Amendments”). Further rules for blacklisting Internet resources The first amendment to Russian law is aimed at securing guarantees, for citizens’ rights, to freely search, access and disseminate information ...
On 12 January 2021, the Ministry of Economy and Finance issued Prakas N0. 009 on the Reclassification of Taxpayers under the Self-Assessment Taxpayer Regime (“Prakas 009”). The purpose of Prakas 009 is to amend the previous classification of taxpayers to ensure that the collection of taxes are carried out in a transparent and equitable manner which is in line with the growth of the Cambodian economy ...
Angola's General State Budget for 2021 (“GSB 2021”) came into force on 1 January 2021 and was approved by Law 42/20 of 31 December. It introduced the following tax changes: Value Added Tax • Definition of the scope of application of Value Added Tax (“VAT”) Individuals or legal entities are now excluded from the scope of VAT when their turnover or import transactions are no more than Kz (AOA) 10 million ...
When it comes to the general transfer of data to third countries, even, for example, intra-group data transfers, recourse to US providers such as Microsoft (Office 365), Amazon (AWS), Google or Salesforce has been ill-fated since the ECJ ruling of July 16, 2020 (C-311/18 “Schrems II”) ...
Some facts and figures that set out the landscape of merger control, antitrust enforcement and competition litigation in Portugal in 2020. Interim Measures The PCA ordered the Portuguese Professional Football League to suspend its decision preventing teams in the First and Second Football Leagues from signing players that have unilaterally terminated their contracts due to the COVID-19 pandemic ...
