Compliance In Focus

The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?

On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of
 cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.

No matter the therapeutic area, device companies agree: Creating cutting-edge products is expensive. From the R&D costs to the pricy FDA fees, the expense for innovation adds up quickly. As products become more technologically advanced, the cost for designing new devices has increased. At the same time, device companies are being hit with fees that are wiping out their R&D budgets, such as the 2.3% medical device tax, which reportedly requires companies to collectively pay an estimated $194 million per month.

Outcomes research can be defined as “the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.” Recently, the push has been for greater emphasis on outcomes and a new joint effort is a giant boost in this direction.

The World Health Assembly is the decision-making body of the World Health Organization (WHO). This assembly draws leading government health officials from the 194 WHO member nations and was first convened in 1948 shortly after the WHO was created. On 24 May 2014, the 67th annual World Health Assembly closed.  This close marked the end to a five day meeting that featured a record-breaking number of agenda items, documents and resolutions, and almost 3,500 registered delegates. During the assembly more than 20 resolutions on important global public health issues were adopted.  These adoptions ranged from issues relating from antimicrobial drug resistance and access to essential medicines to addressing the global challenge of violence and the public impact of exposure to mercury and mercury compounds. Of note, is the passage of a resolution to strengthen regulatory systems.

Medtech companies in the U.S. are concerned about Chinese device manufacturers stealing their intellectual property and making knock-offs that replicate American devices.  However, these devices are not as safe according to Advamed.

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

According to an article in “The Gray Sheet” the FDA is proposing new regulatory language to determine what devices designated Class III devices and not suitable for down-classification.

It just depends!

When and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

The FDA has released its final guidance that outlines an approach to regulating the fast growing and ever evolving category of medical devices that employ radiofrequency wireless technology (RF).  The guidance, which was issued on August 13, 2013, comes more than six years after the original draft guidance was issued in January 2007.

On Tuesday, August 6th, the nation’s 43rd president, George W. Bush, underwent a heart procedure during which a stent was inserted to treat a blockage discovered during an annual physical in Dallas, Texas. According to an article published by NPR, the former president is doing well after the surgery performed at Texas Health Presbyterian Hospital and will be released from the hospital on Wednesday.

Americans are well aware of the ever growing potential of a cyber attack on our credit cards, bank and email accounts, even our social media outlets. But cyber attacks on medical devices? Is this a real threat?

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

Recently, a team of IMARC monitors traveled to a sponsor’s clinical research headquarters to meet face-to-face, study team to study team, to kick off a new medical device study. The two teams joined together with a heavy agenda to get the study’s ducks in a row prior to our monitors hitting the road for the on-site initiation visits scheduled in the upcoming weeks. While this is not always the case at study start-up, with tight timelines and limited budgets, there are many advantages to getting the teams together at the beginning of the study to help prepare for a successful study. Additionally, the teams can process through potential study challenges before they become potentially larger issues. Read on to learn five reasons why the sponsor should meet with and include the CRO in study start up!

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

On April 30, 2013, FDA announced a workshop titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” scheduled for June 13, 2013. The main purpose of the meeting is to discuss the agency’s past, present, and future policy on 510(k) modifications. The FDA is inviting external stakeholders to provide discussion and bring examples of actual device modifications to use in developing future policy.

March proved to be a busy month for China and the government bodies responsible for regulating food and drug safety.

Recently launched,  aptitude's online marketplace main goal is to connect medical device suppliers with device purchasers.  In an article posted on MassDevice.com, aptitude’s Vice President and General Manager described it as being, “like eBay, which provides a marketplace where buyers and sellers can come together."

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all worked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

It is critical that the group of patients enrolled in a study represent the population that may receive the device once it is on the market. Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, according to FDA.

Concerned about your cholesterol? Trying to track your ovulation and hoping to get pregnant? Want to drug test your teenager? There are at home use tests for these questions and more. For around $20.00 dollars you can avoid long doctor’s office waits, submitting claims to the insurance company and discussing potentially embarrassing topics with your primary care physician. But, are these home use tests consider medical devices and therefore subject to the same rigor of clinical trials to confirm accuracy and safety?

Celebrities are constantly making headlines for surgeries-usually those involving popular plastics or silicone.  A shorter list is of those celebrities that went under the knife for other medical treatments-specifically-medical devices or replacements.

Without the willing volunteers to give their consent and participate in clinical research trials many innovative medical devices and life-saving pharmaceutical drugs would never reach patients. FDA and other regulatory bodies exist to protect the rights, welfare, and safety of those subjects choosing to contribute to a study. However, is there an even better way to bring these products to market that would require zero percent risk to human subjects?

Many believe good monitoring should heavily focus on Source Data Verification (SDV), which stripped down to its simplest meaning equates to “X=X” and “Y=Y”.  And maybe some of you reading this are thinking “Isn’t that exactly what monitoring is?”  While data integrity is absolutely essential, it is only the beginning of what comprehensive monitoring encompasses.

Many researchers are proposing a reclassification of all hip joint metal-on-metal hips as there may exist a regulatory loop-hole allowing dangerous devices to reach patients. FDA proposed a new rule that would require these devices to submit a Premarket Approval Application (PMA) which were being accepted through the 510(k) process.

FDA is currently seeking comments on the collection of information regarding the Humanitarian Device Exemption (HDE) applications and related requirements. As summarized by an article in MassDevice, the FDA is interested in learning:

As a follow-up to yesterday’s blog, here is a list of guidance documents FDA plans to fully publish, and intends to publish in the upcoming fiscal year. Remember, these lists and increased transparency efforts are in part the result of FDA negotiations with industry for the Agency to meet different quantitative and qualitative goals for the medical device industry. This is done in hopes to allow safe and effective devices to the public in a faster, more efficient method.

It hit the headlines in a dizzy twist on words. The CEO of St. Jude put the cart before the horse in warning investors that he was expecting a warning letter from FDA before one was actually even issued! According to a report on MedCity News, this type of announcement apparently has no precedent. Have you ever heard of a company proactively telling Wall Street they’re going to receive the dreaded warning letter before receiving it- or even a FDA form 483? This was something that was on the mind of analyst Bob Hopkins of Bank of America.

One great aspect of the research industry is being on the cutting-edge of new, innovative technologies. Looking back at the history of medical devices, it’s amazing how far technology has brought us. New devices are incorporating more complex technologies than ever before. These medical advances are to help treat patients; however, does the increase in innovation also mean an increase in safety risks?

 “One reason I think it’s going to change is we’re starting to see change already.” This statement was made by FDA Head, Dr. Margaret Hamburg, after meeting with senators and med-tech leaders about industry concerns. According to an article by the Star Tribune, the overall tone after the meeting was optimistic and hopes that the FDA Safety and Innovation Act signed into law will help loosen the logjam for approving medical devices.

A recent DeviceTalk blog on MD+DI caught my attention. The article’s title, “What’s in a Medical Device’s Name? For Patients, a Lot” speaks to the fact that for some patients a lifetime is spent with their medical device. This is especially true for those with chronic conditions, like Type I diabetes.

It’s the age old debate… Is the US regulatory system or the EU regulatory system better for the medical device industry? Recently in PLoS Medicine Journal the results of a systematic review was published that evaluated the two systems.

One of the biggest concerns for any device on the market is the possible risk to patients and adverse events tied to the product. In order to improve the quality of information tied to specific medical devices distributed in the US, FDA released a proposed rule for devices to carry a Unique Device Identifier (UDI).  According to the press-release the code is a unique numeric of alphanumeric sequence specific to a device model and also can be tied back to a lot or batch number and expiration date. The FDA provided an example of what a UDI would look like on a medical device label.

Risk analysis is essential in regards to investigational devices. The goal of risk assessment is to remove a hazard or reduce the level of its risk by adding precautions or control measures, as necessary. It’s an important process which can identify problems with investigational products and help eliminate costs, time, and risk associated with recalling the product- but most importantly, protect patients.

You might be surprised to find that the good ole toothbrush is a long time trusted medical device. The FDA Medical definition of a manual toothbrush is “a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.”  This seems to be pretty simple and straight forward! However, recently the International Organization for Standardization (ISO) released new standards for this manual device. The new requirements and test methods include:

Many medical device companies have decided to launch their investigational products initially in Europe.  Representing one-third of the global medical device market, the European Union market provides a significant opportunity for medical device start-up companies.  However, according to an article in MedCity News, it can create many challenges that require proper preparation.

We ran across this interesting article in MD+DI.  According to a report released by the Emergo Group, the average time it takes to obtain 510(k) clearance has risen steadily in recent years.  The findings in the report indicated that the average number of days from submission to clearance increased every year from 2006 to 2010.

It seems as though these days, everyone has a Facebook page, Twitter account, etc. In fact, even public groups and companies are using social media in similar ways and in abundance.

There has been much talk recently about the proposed changes to the regulatory and healthcare systems in the U.S. for the medical device industry. A recent MD+DI article by Nick Woods, director of Woods Medical Media, describes these proposed changes and how they might impact our industry. Woods points out that while President Obama’s PPACA document contains 2074 pages filled with words, for most, one number holds the most weight. The 2.3% sales tax on medical devices expected to come into effect a year from now. The industry seems to be united against this new tax. Our blog last October highlighted Senator Scott Brown’s plight for a repeal, and there have been numerous other calls to have it eliminated.

The FDA released its four main priorities for 2012, and the focus of the FDA will be:

In an article featured on MassDevice, a group of large-cap Med-tech CEOs in a panel discussion at the recent OneMed conference in San Francisco indicated that emerging markets are too complex for smaller firms to navigate. Given the slowing growth of the U.S and European markets, emerging markets are very tempting. However, entry into these markets can be very challenging.

The medical device industry seems to be a limitless pathway of innovation, creativity, and advancements. However, navigating this pathway can be a challenge, and as increasingly complex and combination products enter the arena, more guidance is required to steer the way.

MassDevice reports that the FDA missed its second deadline to submit a proposal to Congress for the Medical Device User Fee & Modernization Act (MDUFMA), which is set to be renewed this year. The device industry and the federal watchdog agency have been in discussion over the fees mandated by the Medical Device User Fee & Modernization Act.

An article in Healing Innovations caught our eye. It reports that the FDA recently released a standard operating procedure (SOP) called “SOP: Management of Review Staff Changes During the Review of a Premarket Submission.”

Recently the FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.

On November 10th, a FDA press release announced they issued a draft guidance aimed at fostering early-stage devices within the U.S.  The guidance contains new approaches toward early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protection.  The FDA is seeking a small number of companies that could pilot the new approach, as the results of the pilot will help inform the final guidance.

The Leahy-Smith America Invents Patent Reform Act that went into effect in late September could help some medical device companies. According to an article in MedCity News, the legislation recently passed by Congress represents the biggest changes to patent law in the United States since 1952.