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 ...
One of the key issues raised consistently in the discussions around a no-deal Brexit is the impact it would have on the customs duties payable on goods that are imported in to the UK. Whilst MPs have now voted against a no-deal Brexit, this does not change the legal position – that unless a deal is agreed, there will be a no-deal Brexit, (or no Brexit at all) ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
Obligation of Czech employers to protect employees from coronavirusPursuant to Section 106 (1) of the Labour Code, an employee has the right be assured of occupational health and safety protection at work (hereinafter referred to as "OHS"), even during a pandemic.Regarding prevention, the provision in section 102 of the Labor Code remains paramount ...
As a result of the COVID-19 changes to foreign investment in Australia announced on Sunday, investors that are now caught by the Foreign Investment Review Board (FIRB) regime will also be subject to scrutiny from other regulators. Our team explains what this means for investors and what they can do to manage this process ...
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire concurrently with the expiration of the PHE on May 11, 2023 at 11:59 PM ...
Aid for self-employed persons and small and medium-sized enterprises (SMEs) affected by anti-coronavirus measures pursuant to the Czech Government’s 'COVID GUARANTEE' programme was exhausted in one day. On Monday, March 30, 2020, the terms and conditions of the follow-up COVID II program will be published, in which CZK 5 billion should be available. The rush of applications is expected, so action needs to be taken quickly and not delayed ...
Covid III is starting and you need to act fast! At its meeting on 18 May 2020, the Government approved by Resolution No. 553 the Covid III guarantee program for self-employed persons and companies employing up to 500 employees. Immediately afterwards, the websites of Českomoravská záruční a rozvojová banka, a.s. ("ČMZRB") published the conditions of the program ...
The new COVID Prague program focused on business activities in the Capital City of Prague followed the fate of its predecessors COVID I and COVID II. This means that the available funds were exhausted on the same day as the receipt of applications, which thus ends. The COVID I and COVID II programs are also exhausted. Entrepreneurs thus have no choice but to wait for the announcement of the conditions of the COVID III program ...
The state contribution for commercial rents to entrepreneurs with forcibly closed establishments is gaining more concrete outlines. If an entrepreneur negotiates a 30% discount on rent from his landlord, he will be able to apply for state support in the amount of 50% up to a ceiling of CZK 10 million for the period from April to June. However, the program has yet to be notified to the European Commission before it can be launched ...
(continuation from Part I - separate article) Part II - "Antivirus Programme" - Financial Assistance to Czech Employers The Ministry of Labour and Social Affairs was mandated by the Government to further prepare a compensation program for entrepreneurs who continue to operate but whose production has decreased due to measures (category C of the Antivirus Programme) ...
Czech Government Approves Mitigation Measures Related to Coronavirus Emergency UPDATED In connection with the coronavirus emergency, the Czech government has approved a liberation tax package aimed at mitigating the consequences of the emergency ...
Impact of the Czech Government measures on employment relations The current situation has a considerable impact on employment relations ...
The Centers for Disease Control (CDC) reports swimming is the fourth most popular recreational activity in the United States and the most popular recreational activity for children (ages 7 to 17). Statistics further show 36 percent of children and 15 percent of adults go swimming at least six times a year in the United States ...
The impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...
In this article we look at the impact the COVID-19 pandemic has had on the social and health care sector in the build up to the upcoming Public Inquiry, due to commence in Spring 2022. Upsetting scenes arising from the COVID-19 pandemic included photographs of bereaved families with only six people in attendance at family funerals ...
This 28th edition of Unprecedented, our weekly update on COVID-19-related litigation, includes a number of updates on the mounting number of business interruption coverage disputes -- including a claim against a broker whose alleged failure to obtain infectious disease coverage left the insured without coverage for COVID-19-induced losses ...
The General Meeting during the State of Emergency? Can it take place? And can it be convened? Do crisis measures contain an exception for meetings of the statutory organs of the company (e.g ...
Czech Health Ministry's Special Measures UPDATED The government explicitly stated in the Emergency Resolution that the Health Ministry’s existing emergency measures are not to be affected by the state of emergency, which means that they remain valid and must be observed. All the Health Ministry’s special measures introduced valid after the emergency was announced must be observed as well. A brief summary (updated on 19March 2020) is outlined below ...
The offence of spreading coronavirus From what point exactly is the spreading of COVID-19 a criminal offence? Is it only intentional spreading that is punishable or is negligence also a criminal offence? What is at stake? What are the aggravating circumstances and when do the penalties increase? And can these criminal offences also be committed by a legal entity? The Government of the Czech Republic adopted, as a part of emergency measures due to health threat, Regulation No ...
On May 27, 2020, the U.S. Patent and Trademark Office issued a further extension of certain deadlines that were about to expire on May 31. The latest order provides until July 1, 2020 for certain actions delayed due to COVID-19. For small and micro entities only, filings that would have been accepted if filed by June 1, 2020, will now be deemed timely if filed by July 1, 2020 ...
Businesses in need of capital may find themselves facing foreign investment regulatory hurdles. We discuss the challenges for businesses and the potential for regulatory relief. Australia's foreign investment regime applies very broadly and captures many transactions. As businesses consider how to respond to the demands of the current COVID-19 economic environment, they may be required to go through the Foreign Investment Review Board (FIRB) screening regime ...
