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Regulating Medical Devices Shapes Industry for the Better

Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to go through a complex system of regulatory approval. In order to obtain market entry, some argue that regulatory agencies like the US-based Food and Drug Administration (FDA) are too zealous, preventing or delaying life-saving innovations from entering the market. Richard Williams, an affiliated scholar at the Mercatus Center at George Mason University, cites an example where three medical devices submitted for approval took nine years to process. He argues that it costs on average $24 million to manage FDA requirements. “A mid-1970s law,” he argues, “requires virtually every medical device—and improvements to existing devices—to endure a slow, expensive, uncertain approval process, ill-suited to 21st-century technology. The Food and Drug Administration (FDA), which grants such approval, has an ageing structure and culture that adds extra layers of discouragement to would-be innovators.” But what are the benefits of regulation, and how can pharma and tech companies manage the process of compliance more smoothly? MethodSense is a company that exists to assist companies with FDA and other regulatory agencies to obtain market entry for their medical device products. We talked to Rita King, CEO of MethodSense, and Russ King, President of MethodSense, about what they do and why regulation matters. What kinds of services do you provide as a company? “MethodSense’s consulting service approach is a little...
FDA Announces FY 2018 MDUFA Fees

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees for certain medical device applications, submissions, reporting on class III devices and fees for establishments subject to registration. These fees are in effect from October 1, 2017 through September 30, 2018. 2018 MDUFA Fees FDA user fees have increased across all categories. This increase will substantially impact larger companies. Most FDA user fees increased 33%; however the standard application fee for a 510(k) submission rose 125% to $10,566. The increase in fees is a result of inflation adjustment plus any additional increase FDA feels is necessary to reach the inflation adjusted total revenue amount the agency has identified for the year. Application Type 2018 Standard Fees 2018 Small Business Fees 510(k) premarket notification submission $10,566 (+125%) $2,642 (+13%) 513(g) request for classification information $4,195 (+33%) $2,098 (+33%) Premarket application (PMA) $310,764 (+33%) $77, 691 (+33%) De novo classification request $93,229 (new) $23,307 (new) Annual fee for periodic reporting on a class III device $10,877 (+33%) $2,719 (+33%) Annual establishment registration $4,624 (+37%) $4,624 (+37%) Qualifying for Small Business User Fees At the same time that the FDA announced their 2018 fees, they also updated their guidance FY 2018 Medical Device User Fee Small Business Qualification and Certification. A business that is qualified as a “small business” is eligible for reduced user fees. A small...
FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA for recognition of a standard that has been established by a nationally or internationally recognized standard organization. What Are Recognized Consensus Standards A recognized consensus standard is a national or international standard that FDA has evaluated and recognized for use in satisfying a regulatory requirement and for which FDA has published a notice in the Federal Register. Many consensus standards address aspects of safety and effectiveness that are relevant to medical devices. When a medical device manufacturer is submitting a premarket application, such as a 510(k), Investigation Device Exemptions application (IDE) or a Premarket Approval application (PMA), it must demonstrate to CDRH (Center for Devices and Radiological Health) that their device is safe and effective. Applicants may be able to demonstrate safety and effectiveness by conformance to FDA-recognized consensus standards. When planning performance and safety testing, manufacturers should review the list of FDA-recognized standards to determine if the standard they are considering is listed. FDA recommends that plans to conform to particular standards be discussed during pre-submission meetings. If testing has already been conducted to a standard not recognized by the FDA but acceptable in another market, a request for recognition will need to be submitted to FDA. If testing has already been conducted to a past version of a standard that the FDA...
FDA Issues New List of 510(k) Exempt Medical Devices

FDA Issues New List of 510(k) Exempt Medical Devices

New Class II 510(k) Exempt Medical Devices As part of the FDA’s movement to decrease regulatory burdens on the medical device industry, the agency published a list of more than 337 Class II product codes of 510(k) exempt medical devices (see the FDA’s Federal Register notice). The FDA has determined that assurance of safety and effectiveness of these devices can be provided by other regulatory controls. By issuing exempt status for these devices, the FDA can redirect resources that would have been spent reviewing these submissions to more significant public health issues. In March of this year, the FDA published a draft of their proposed Class II devices to be exempted in accordance with the 21st Century Cures Act. FDA is now required to publish a list of Class II devices that no longer require premarket notification, also known as 510(k) exempt medical devices, at least once every five years. 93 product codes are now 510(k) exempt subject to partial exemption limitation in addition to general limitations. So, it will be important for manufacturers to confirm if their device is indeed exempt. For example, FDA exempted devices regulated under product code DHB (Radioallergosorbent immunological test system), but they do not believe all products with the product code DHB meet the partial exemption limitation. Therefore, you are still required to file a 510(k) submission if your device falls under product code DHB and is not identified on the list. Pending 510(k) Submissions Medical device manufacturers with pending 510(k) submissions that are now on the list of exempted devices are directed to withdraw their submission. This is great news for these...
FDA to Create a Digital Health Unit

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital health premarket review timelines. Digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. The creation of this unit is part of the Medical Device User Fee Act (MDUFA). MDUFA is the program that authorizes FDA to collect user fees from medical device manufacturers in support of streamlining the regulatory approval process. Negotiations between FDA and the medical device industry regarding the fourth version of MDUFA are currently underway. As part of the negotiation process, FDA proposed to hire technical experts to staff the new digital health unit. In addition to MDUFA, the 21st Century Cures Act requires FDA to develop a framework for evaluating real world evidence. FDA envisions that the digital health unit will monitor and implement the use of real world evidence to support the regulatory approval process. FDA issued a draft guidance in July 2016, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, that identifies how real world data will be evaluated to determine if it is sufficiently relevant and reliable enough to be used. While the FDA sees the digital health unit as a means of streamlining the regulatory approval process, it also recognizes it will require coordination with industry and other government agencies because digital health touches on...
Obama Signs the 21st Century Cures Act into Law

Obama Signs the 21st Century Cures Act into Law

Last night, President Obama signed the 21st Century Cures Act into law. Most of what people will be hearing from the media will be focused on the Act’s support of cancer research, mental health policies, brain research to tackle diseases like Alzheimer’s and the funding allocated for these initiatives. However, the 996-page bill also includes major changes that impact the way the FDA regulates drugs, devices and biologics. Those who have spoken out against the Cures Act have done so out of fear of a weakened system that would allow for less rigorous examination of products before they go to market. While there are sections of the act that appear to streamline submission and review processes, until the FDA develops the necessary guidances based on their interpretation of the requirements, the industry will not know what to expect. The best way to approach these pending changes is to become familiar with the areas that might impact your device. The following summarizes provisions relevant to medical device companies: Sec. 3001 Patient Experience Data Under the Cures Act, FDA would be required to include a statement regarding any patient experience data that was used at the time of a drug’s approval. The bill defines patient experience data as “data collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers).” While this section specifically refers to drugs, this may come into play for combination products, as well. This requirement, as well as section 3002, is one to watch to determine if it affects your product commercialization goals. Sec. 3033 Accelerated...