March 4 2013, The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the Read more about Guidance on pulse oximeter applications[…]
Yesterday FTC has come up with a set of guidelines for online advertising aiming in particular, to address the myriad questions surrounding the use of such tools as Twitter and Facebook to promote products and disseminate messages.The key question is , FDA going to follow it, copy it if yes to what extent. The various Read more about FTC Online Ad Guidance – what will FDA do ?[…]
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. The proposed regulation would require that clinical studies conducted outside the United States in support of an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a Read more about FDA Proposes New Rule for Acceptance of Data from Clinical Studies for Medical Devices[…]
Now EU is mulling ban on virtual currencies and particularly bit coins as it seems there are more chances of irregularities which might happen and antisocial elements can use this route to beat the current regulations. “It’s imperative to move quickly on this issue,” Chantal Hughes, a spokeswoman for Financial Services Commissioner Michel Barnier, said Read more about Virtual currencies, gold, money laundering, regulations etc[…]
The Fair Labor Standards Act (FLSA) of 1938 is key piece of compensation legislation. Although FLSA has been around for a long time, it is the most frequently violated employment law. Employers misclassify employees as exempt or fail to calculate working time accurately. Misclassifications can result in severe back pay issues. Calculating overtime incorrectly can often result Read more about Complying With FLSA Requirements[…]
There are three primary set of export and sanctions rules. These are: U.S. Export Administration Regulations (EAR) International Traffic in Arms Regulations (ITAR) Economic Sanctions Regulations U.S. Export Administration Regulations Export Administration Regulations (EAR) are found in 15 CFR Parts 730 to 744. These are administered under International Economic Emergency Powers Act by the Commerce Read more about U.S. Export/Sanctions Laws[…]
Over the last several years, the regulatory framework for export controls and economic sanctions in the U.S. has undergone significant changes. At the same time the risk of enforcement in the event of non-compliance has grown.Most products and technologies contemplated for export from the U.S. fall under the requirements of the Export Administration Regulations EAR. Read more about Export Administration Regulations[…]
Equal Employment Opportunity requirements It’s all about INCLUSIONAnyone QUALIFIED should have access to the candidate pool. Unqualified do not need to be considered Use of a NON-DISCRIMINATORY SELECTION PROCESS to compare and determine applicants chosen for placement Affirmative Action requirements It’s all about ASSIMILATION ASSURE minority and female REPRESENTATION in all candidate pools Follow EEO Read more about EEO vs AA[…]
Interns are viewed as employees unless below all six conditions apply The internship, generally include actual operations in the office of the employer, but is similar to educational training that would have got in the school environment. The intern is not necessarily entitled to a job at the conclusion of the internship The work they Read more about How to segregate Interns vs employees[…]
CTD Triangle showing 5 modules in pictoral form as shown below infographic