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 ...
Following the renewal of the state of emergency, Decree 3-A/2021 of14January of the Presidency of the Council of Ministers, determines the closure of various types of establishments. Inthiscontext, the employment support measures were amended by Decree-Law 6-C/2021 of 15 January and Decree-Law 6-E/2021 of15January, which we summarised below. 1 ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
Traditionally, Dutch mortgage lenders have always found themselves in quite a good position in the event of their borrower and mortgagor becoming insolvent. As a firm general rule, it is fair to say that the position of a secured creditor is quite secure under Dutch law. Recent insolvency and COVID related regulations have, however, made some inroads into the Dutch secured lender’s stronghold ...
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 ...
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 ...
Dr Michael Psaila, Managing Partner of Mamo TCV Advocates, underlined the firm’s commitment to the visually impaired and the Malta Guide Dogs Foundation (MGDF) in particular when he not only presented a donation but committed the firm to assisting the foundation in its legal affairs in the coming years. It was the wish of the firm, which has a staff complement of over 70 people, to select the MGDF as one of the beneficiaries of their annual charity donation ...
The Electronic Communications Code was subject to a wholesale re-write in 2017, with the intention of facilitating the faster roll-out of the UK’s digital communications infrastructure. Three years on, the government has commenced a consultation on proposals to revise aspects of the Code to ensure it is fit for purpose ...
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 ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
The Pension Protection Fund (PPF) has published its determination for the levy year 2021 to 2022, following its autumn consultation. Ordinarily, the PPF considers matters across the levy triennium with a view to keeping the rules relatively stable on a triennial basis. However, in considering the impact of COVID-19 on schemes, the PPF wishes to take a more flexible approach with the aim of switching back to a multi-year approach in 2023/24 ...
Bank Negara Malaysia issues Licensing Framework for Digital Banks Bank Negara Malaysia issued its policy document on Licensing Framework for Digital Banks on 31 December 2020. It has indicated in its press release that up to five licences may be issued to qualified applicants and notification of the grant of licence will only be made by the first quarter of 2022 ...
Domestic extremism is not new, but heightened law enforcement scrutiny in the wake of the Capitol riots has added yet another layer of complexity to the jobs of already challenged AML compliance professionals and investigators ...
On 26 January 2021, the Central Bank of Myanmar (the “CBM”) issued Notification1/2021 (the “Notification”) outlining the requirements and specifications for the establishment, operation and business activities of non-bank financial institutions (“NBFIs”). This Notification is effective from 26 January 2021. 1 ...
California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed sweeping changes to the popular “short-form” Proposition 65 warning. On January 8, 2021, OEHHA issued a proposal to amend Article 6 “Clear and Reasonable Warnings” Section 25601. This Article sets forth “safe harbor” warning methods, including warnings for consumer product exposures ...
Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2020 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. Despite the pandemic and the smallest recoveries for the Department of Justice in over a decade, FCA enforcement remains robust. As always, the healthcare industry remains the most frequent subject of FCA cases and investigation ...
Current State of Shopping Centers Our legacy shopping centers are often well-located, near transportation routes, population centers and employment hubs. Post-recession enthusiasm for shopping encouraged the expansion of many retail stores and product lines, and rental rates for prime shopping locations continues to grow ...
The Government of the UAE made another milestone announcement on 30 January 2021, announcing a procedure for the granting of citizenship to foreign nationals in a bid to retain talent in critical sectors and to expand and diversify the economy. Nationality and citizenship in the UAE are governed by Federal Law No. 17 of 1972 Concerning Nationality and Passports, as amended by Federal Law No. 10 of 1975 and Federal Decree-Law No ...
Changes to the off-payroll working rules for private sector organisations originally planned for April 2020 will now come into force from 6 April 2021. As a result, large and medium sized organisations engaging contractors through an intermediary will have various responsibilities and potential liabilities ...
Aron Beezley of Bradley Arant Boult Cummings LLP outlines the Justice Department's noteworthy procurement fraud recoveries for fiscal year 2020. The Department of Justice (DOJ) recently announced1 that it obtained more than $2.2 billion in False Claims Act (FCA) settlements and judgments in the fiscal year ending September 29, 2020 ...
The information listed below is categorized by topic for your convenience and includes content from the previous week. Bradley is actively monitoring and engaging with relevant federal, state or local entities on issues related to the coronavirus. Please contact one of the authors if you have any questions. Click on a link below to view the full article, alert, blog, webinar recording or interview ...
An Eleventh Circuit panel has breathed new life into a long-running, $248 million False Claims Act (FCA) qui tam case, United States ex rel. Bibby v. Mortgage Investors Corp.,[1] reversing the district court’s grant of summary judgment for the defendants.[2] Materiality lay at the heart of the case, which involved allegations that the defendant finance companies misled the U.S ...
In recent years, Russia has focused on regulating its IT area. In particular, this has been needed due to the increasing number of cases, when prohibited information has been distributed on various large Internet resources, such as a social network. However, according to Russian government agencies, despite the risks of possible sanctions, many foreign companies still do not respond quickly enough to government requests, or ignore the demands to remove prohibited information ...
