Compliance Resources to Help you Stay Current

The US FDA has issued final guidance intended to assist FDA staff and those in the healthcare industry with submitting investigational device exemption (IDE) applications to conduct clinical trials for neurological medical devices.

The guidance applies to medical devices designed to target the cause or progression of neurological diseases, such as Alzheimer’s disease, Parkinson’s disease, or primary dystonia. The final guidance offers general study design considerations for clinical trials that investigate neurological devices using biological markers and clinical outcome assessments.

FDA Releases Draft Guidance on Software as a Medical Device (SaMD): Clinical Evaluation

The US FDA has released the draft guidance on the clinical evaluation of software as a medical device (SaMD) prepared by the International Medical Device Regulators Forum (IMDRF). The Draft Guidance describes standards for determining the clinical validity by demonstrating the analytical validity, the scientific validity and clinical performance of the SaMD.

Six US senators push FDA for a ban on medical devices that are used to administer electric shocks to patients with developmental disabilities. With the view to help modify their behavior, the senators wrote to FDA petitioning Commissioner Robert Califf to cement a ban that would outlaw the use of electrical stimulation devices employed for treating aggressive behavior.

A few months earlier, the FDA proposed a similar ban on devices that use electrodes attached to the skin to deliver electric shocks to prevent individuals/patients from engaging in certain behavior. In addressing these proposals to bar the devices, the FDA said it “determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.”

Currently, the FDA is in the process of reviewing public comments submitted in response to the proposal.

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Does your medical device require a 510(k) application? The process of submitting a 510(k) application can pose many challenges for device manufacturers as each 510(k) submission is dynamic depending on the type of device, the risk level, its history, etc. A final 510(k) submission should be a completed comprehensive document including all 21 sections and other information needed for approval by the FDA. Therefore, it is vital to have a strong understanding of the latest 510(k) submission requirements and how they relate to your device.

In January the European Parliament's committee responsible for public health voted in favour of a revised version of the EU Clinical Trial Regulation initially proposed by the European Commission in July 2012.

On May 10 2012, the FDA released new draft guidance on "Paediatric Information for X-ray Imaging Device Premarket Notifications". This new guidance provides health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on paediatric patients. This guidance applies only to complete x-ray imaging devices that could be used on paediatric patients.

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.

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.
 

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.
 

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.

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

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

In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.

This article gives a brief overview and summary of recommendations contained in this draft guidance.
 

On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.

This article gives an overview of the new guidance and recommendations.

The FDA will soon be implementing a new import screening tool, Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT. This system is expected to improve the current electronic screening system by targeting higher risk products and minimizing delays in shipping lower risk products.

This article gives a brief overview of the PREDICT tool and recent developments in its implementation.

The IEC 62304 is a global harmonized standard adopted by the US and EU. It gives life cycle requirements for medical device software as well as medical software.

This article gives an overview of the standard and a summary of the IEC 62304 requirements for software development.

As medical devices become increasingly available for home use and more use-accessible and friendly, it has become important for manufacturers to ensure the product’s quality, safety and reliability. Medical device quality regulatory requirements issued and enforced by agencies such as the FDA act as a valuable guide for manufacturers.

This article gives a brief overview of the FDA’s medical device quality system regulations.

Medical devices need to be reliable and safe - and reliability engineering is key to ensuring this. But how do you effectively leverage reliability engineering to create successful devices?

Dev Raheja, a recognized expert on medical devices, explains how and why reliability engineering matters during the production of medical devices.

The FDA has for the first time issued a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily. The agency is presently accepting comments on these draft guidelines.

This article provides a summary of the guidance document’s recommendations.