Compliance Resources to Help you Stay Current

On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.

In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.

This article gives an overview and summary of requirements of the code.

The American Red Cross, which supplies 40 – 45% of donated blood in the U.S., was recently fined by the FDA for substandard and unsafe practices on blood management and for failing to rectify these violations. This article details the reasons behind the FDA fine and the laws that were violated.

The European Banking Authority (EBA) has published its new Guidelines on Internal Governance. These aim at enhancing and consolidating supervisory expectations and improving the implementation of internal governance arrangements for individual institutions and the banking system as a whole.

This article gives a brief summary of the EBA Guidelines.

Yes. While the Federal Reserve will conduct annual stress tests on all companies covered by the newly proposed rules, companies will also have to conduct their own semi-annual stress tests.

Any state member bank, bank holding company or savings and loan holding company with more than $10 billion in total consolidated assets (that is not a covered company) has to conduct its own annual stress tests, i.e. company-run stress tests.

The results of these stress tests should be summarized and made public.

Read a full summary of the requirements of the new proposed Federal Reserve Prudential Standards and Early Remediation for Covered Companies.
 

No – the proposed Federal Reserve rules issued in December 2011 would only apply to US bank holding companies with consolidated assets of $50 billion.

The new rules would also apply to any nonbank financial firms that may be designated by the Financial Stability Oversight Council as systemically important companies.

The early remediation requirements included in the proposed rules would be triggered by specific issues such as capital levels, stress test results and risk management weaknesses. These would be calibrated to forward-looking in some cases.

If triggered, early remediation actions would include:

• Restrictions on growth
• Capital distributions
• Executive compensation
• Capital raising
• Asset sales

Read a full summary of the requirements of the new proposed Federal Reserve Prudential Standards and Early Remediation for Covered Companies.

No. The FDA is trying to increase the representation of women in clinical studies of medical devices. According to the FDA’s recently issued draft guidance on Evaluation of Sex Differences in Medical Device Clinical Studies, medical device clinical trial sponsors can create tailored communication strategies (as used in the Women’s Health Initiative study) for study recruitment, informed consent documents and patient labeling.

The guidance also recommends that device manufacturers and developers, where appropriate, can target investigational sites where recruitment of women can be more easily facilitated. These investigational sites include women’s clinics.

Read an overview and summary of recommendations of the new FDA draft guidance aimed at increasing the representation of women in device clinical studies.
 

On December 20, 2011, the Federal Reserve proposed new rules that would strengthen regulation and supervision of large US bank holding companies and systemically important nonbank financial firms.

This article gives a brief overview and summary of requirements of these new rules.
 

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

This article gives an overview and summary of recommendations included in this FDA draft guidance.
 

No – Over-the-Counter or OTC drugs are not covered by the Centers for Medicine and Medicaid Services’ (CMS) newly proposed Physician Payment Sunshine rule.

According to the Act and proposed rule, the requirements apply to manufacturers of a “covered drug, device, biological, or medical supply."

A covered drug, device, biological or medical supply refers to any drug, biological product, device, or medical supply for which payment is "available" under Medicare, Medicaid, or CHIP.

Over-the-counter (OTC) drugs and biologicals are not covered by this rule.

Read an overview and summary of requirements of the proposed rule.

Yes – but only payments above $10 made to covered recipients (i.e., physicians or teaching hospitals) have to be reported by manufacturers under the proposed rule, part of the enforcement requirements included in the Physician Payment Sunshine Act of 2010. This rule has been drafted by the Centers for Medicine and Medicaid Services (CMS), which has been tasked by the government to enforce the Act’s requirements.

For failing to report, manufacturers will be subject to a civil monetary penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported.

For knowingly failing to report, manufacturers will be subject to a civil monetary penalty of not less than $10,000, but not more than $100,000, for each payment or other transfer of value or ownership or investment interest not reported.

Read an overview and summary of requirements of the proposed rule.
 

No – the new EPA Mercury and Air Toxics Standards (MATS) specifically apply to electric utility steam generating units or EGUs that are larger than 25 megawatts (MW) that burn coal or oil for the purpose of generating electricity for sale and distribution through the national electric grid to the public. These EGUs include those providing electricity for commercial, industrial and residential uses owned by:

• Investors
• The Federal Government
• Municipalities
• Cooperatives

The EPA estimates that around 1,400 units at 600 power plants will be affected by these standards, i.e.:

• Approx. 1,100 existing coal-fired units
• 300 oil fired units

Read a summary and overview of the requirements of the new MATS issued by the EPA.
 

On December 16, 2011, the Environmental Protection Agency (EPA) issued the first ever national standards aimed at reducing the emissions of toxic air pollutants from power plants. The EPA was required by the Clean Air Act of 2000 to formulate and enforce these standards.

This article gives a brief overview of the new Mercury and Air Toxics Standards (MATS) for power plants issued by the EPA.
 

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

This article gives a brief overview of the proposed rule and its requirements.
 

No – not all medical device malfunctions have to be reported by a manufacturer. If they are not likely to result in death, serious injury or other significant adverse event experiences, malfunctions need not be reported.

A malfunction that is found or corrected during routine service of the device must be reported if its recurrence is likely to cause or contribute to death or serious injury.

If any of the following happens, then a malfunction is considered reportable:

1. The chance of death or serious injury occurring as a result of a recurrence of the malfunction is not remote;
2. The malfunction affects the device in a catastrophic manner and may lead to the death or serious injury of the patient using it;
3. It causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness. This in turn can contribute to a death or serious injury, or other significant adverse device experiences. The essential function of a device refers not only to the device's labeled use, but for any use widely prescribed in medical practice;
4. It involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used;
5. There is malfunction in the device considered life-supporting or life-sustaining, and essential to maintaining human life; or
6. The manufacturer is required to take action under section 518 or 519(f) of the FD&C Act as a result of the malfunction of the device.

Read the best practices that medical device manufacturers must follow in the medical device reporting (MDR) process.

Yes – as shown by the Department of Health and Human Services’ (HHS) overruling of the FDA’s approval of the sale of Plan B contraceptive pill to adolescents without a prescription.

This, however, is the first time in history that a senior US government official overruled the FDA’s approval for a drug. Until this, the FDA’s approval for a drug was considered final. The decision by Kathleen Sibelius, the Secretary of the HHS, has set a historical, and controversial, precedent. Many observers (from the industry, scientific and healthcare fields) feel that this has diminished the FDA’s scientific drug approval process. Critics of the decision say that political considerations have trumped scientific decision-making.
 

The Australian Prudential Standard 112 – Capital Adequacy: Standardized Approach to Credit Risk aims at ensuring that “ensure that an authorized deposit-taking institution holds sufficient regulatory capital against credit risk exposures.”

This article gives a brief overview of the standard and its requirements.
 

The Australian Prudential Standard 110 – Capital Adequacy aims at ensuring that “authorized deposit-taking institutions maintain adequate capital, on both an individual and group basis, to act as a buffer against the risks associated with their activities.”

This article gives a brief overview of the standard and its requirements.
 

Yes – the CFTC’s newly approved Client Funds rule or “MF Global” rule allows futures brokers and brokerage firms to invest client funds in US Treasuries. They are, however, banned from investing client money in in-house transactions or repurchase agreements (repos) and foreign sovereign debt.

No. The FDA's Abbreviated New Drug Application or ANDA process, used by generic manufacturers to apply for approval for their copies of drugs, does not require the company to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

Instead, generic manufacturers need to show that their product is bioequivalent or performs in the same manner as the original, innovator drug.

Bioequivalence can be demonstrated by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.