Whistleblower Tips Surpass 3,000 in 2012

According to a recent report issued by the Securities and Exchange Commission, the SEC’s Office of the Whistleblower (OWB) logged 3,001 tips from all 50 states (as well as D.C. and Puerto Rico) and 49 countries in fiscal year 2012. The most common complaints were related to corporate disclosures and financials (18.2%), offering fraud (15.5%), and manipulation (15.2%).

“In just its first year, the whistleblower program already has proven to be a valuable tool in helping us ferret out financial fraud,” said then-SEC Chairman Mary L. Schapiro in a statement about the report. “When insiders provide us with high-quality road maps of fraudulent wrongdoing, it reduces the length of time we spend investigating and saves the agency substantial resources.”

The SEC is authorized to pay whistleblowers 10% to 30% of the sanctions collected; these awards are drawn from the Investor Protection Fund established by Congress.

Design Control Best Practices - Free White Paper

Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies. Manufacturers who have lax controls over design and development of devices also have to recall products as they may endanger user safety. Such actions have a negative impact not just on company profit margins, but also reputation and public trust.

This white paper discusses six best practices that medical device manufacturers should follow

1. Robust and Detailed Design and Development Plan
2. Ensure Design Input Includes All Necessary Elements
3. Carry Out Detailed Design Reviews
4. Verify and Validate Device Design
5. Do Design Transfer Correctly
6. Maintain Complete Design History Files

CLICK HERE TO READ THE DETAILS OF THIS WHITEPAPER

Transfer of responsibility for consumer credit regulation from the Office of Fair Trading to the new Financial Conduct Authority in April 2014

On March 6 2013 The UK Government published a proposal document to the transfer of responsibility for the regulation of consumer credit from the Office of Fair Trading to the new Financial Conduct Authority in April 2014

FSMA model proposed























The publication of this consultation document confirms the commitment to transfer consumer credit regulation to the Financial Conduct Authority (FCA) in April 2014 and sets out details of the new regulatory regime for consumer credit. Reform of the regulation of consumer credit is the final piece in the jigsaw of the Government’s comprehensive regulatory reform programme for financial services. The transfer will, for the first time, bring conduct of business regulation under a single financial services regulator, ending confusion for consumers, duplication for many firms, and ensuring a single strategic regulatory view across retail financial services.

Download the Consultation on framework for the consumer credit regime

Fraud Busting Agency in Fraud net

As per Reuters - The former head of Britain's Serious Fraud Office (SFO) was on Thursday accused of running a "sloppy and slovenly" operation and agreeing exotic senior staff packages and payoffs with scant regard to the public purse or proper procedure.

In a public grilling into exit payments to three top executives, parliamentarians told Richard Alderman, who left the agency last April, it was unacceptable that his former CEO Phillippa Williamson ran up 27,600 pounds ($41,600) in one year in UK travel and hotel costs.

The Public Accounts Committee (PAC) parliamentary spending watchdog also voiced outrage at Alderman's reliance on informal notes and conversations before paying three top executives a total of around 1 million pounds in payoffs -- and questioned whether Williamson was an old friend.

The hearing heaped further embarrassment on the agency, which has struggled to restore faith in its fraud-fighting capabilities since a botched probe into property moguls Vincent and Robert Tchenguiz left it fighting a 300 million pound ($452 million) damages claim.

Read Detailed News 

UK fraud-busting agency head ran "sloppy" operation-MPs

Guidance on pulse oximeter applications

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 1992 guidance on the same category. it will help device companies prepare their premarket notifications, or 510(k)s, for any pulse oximeter.

Scope 

The scope of this document is limited to the Class II devices, Oximeter and Ear oximeter, classified under the following regulations:

21 CFR 870.2700 – Oximeter (product codes: DQA (Oximeter) and NLF (Oximeter, Reprocessed))

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.Contains Nonbinding Recommendations

This guidance does not address oximeters in product codes MUD (tissue saturation oximeter), NMD (reprocessed tissue saturation oximeter), or MMA (fetal pulse oximeter).

21 CFR 870.2710 –Ear Oximeter (product code: DPZ (Ear oximeter))

An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.