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 ...
The Minister of Communication and Informatics (“MOCI”) has finally issued MOCI Regulation No. 5 of 2020 on Electronic System Organizers (“ESO”) in the Private Sector (“MOCI Regulation 5/2020”) that serves as the new implementing regulation of Government Regulation No ...
On 30 December 2020, Bank Indonesia issued Bank Indonesia Regulation No. 22/23/PBI/2020 of 2020 on Payment Systems (“Payment Systems Regulation”). The Payment Systems Regulation is intended to serve as an “umbrella” regulation that provides a regulatory framework for the Indonesian payment systems industry. This regulation will come into force on 1 July 2021 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 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 ...
In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
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 ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
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 ...
A new Royal Decree published on 21 January 2021 in the Belgian Official Gazette has temporarily extended the occupational doctor's role in combatting the Covid-19 virus ...
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 ...
A change in administrations from Republican to Democratic usually ushers in increased enforcement, regulation and strategic initiatives. Most of the Trump regulations and initiatives will likely be scrapped where possible. They will be replaced by rules and guidance documents that have been held in abeyance during the previous administration, as well as numerous new initiatives ...
I. Banco de Portugal Communication of Banco de Portugal on the Synopsis of Behavioural Supervisory Activities - first half of 2020. Communication of Banco de Portugal on the imposition of a capital reserve on institutions identified as “other systemically important institutions”. Banco de Portugal Communication on the Economic Bulletin of October 2020. Communication of Banco de Portugal on the implications of Brexit ...
