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By Dawn Wydner, Independent Consultant

I’m amazed as I watch a Health Care System and then a Spectrum commercial to what our future holds with the sophisticated, interactive medical device and technology innovations and how they will enhance the capabilities of diagnosis and treatment. My regulatory mind then kicks in and wonders how these amazing innovations will pose operational and data reliability challenges for both industry and regulators in areas ranging from clinical trials to device design and development, and ultimately to the commercially approved and marketed devices.

For Federal Agencies and other institutions involved in the evaluation, funding, manufacturing, distribution, and clinical use of medical devices, it is clear that the landscape of these activities will be changing in considerable ways. The increase in minimally invasive methods and devices to reduce lengthy recoveries, developments in decentralized care, tissue engineered devices, advances in diagnostic and “smart” products, to the growing sophistication of electronic medical information systems hold for substantially better-informed diagnoses and treatments. Yet, these same developments will generate increased pressure for more effective data capturing systems and methods to handle the data, coupled with concerns related to device accountability, source, supply/availability, and quality.

Regulatory health authorities around the globe are taking steps to be prepared. Are you ready and will you be in compliance when new and upcoming regulations take effect…

Data Acceptance

The FDA issued a final rule, effective Feb. 21, 2019.

Under the new rule, FDA is requiring sponsors and applicants to affirm that clinical investigations outside the United States were conducted in accordance with Good Clinical Practices (GCPs) when the data are submitted for medical device applications.[1] The final rule also amends criteria for investigations conducted within the United States to require applicants and sponsors to state that the investigation complies with FDA regulations for human subject protection, institutional review boards, and investigational device exemptions (IDEs).[2] If an investigation is not conducted in accordance with those regulations, a brief statement of the reason for the noncompliance is required.[3,4]

The US FDA’s new requirements will affect device development strategies, including where to conduct such trials. The necessary patient population in the disease prevalent area of the clinical trial may not have the economic means for network availabilities to fully comply with the use of the sophisticated investigational device product. Education of ex-US trial sites will need to be enhanced, and cost of ensuring trial sites have adequate systems and equipment to effectively run and capture trial data will need to be considered as part of the strategic site selection process without creating bias.

European Union’s (EU) Medical Device Regulation (MDR)

The EU MDR is expected to come into effect in late 2019 or early 2020. This will give national regulators more control and oversight of the medical devices industry. The aim of the new regulation is to ensure that products are effective and safe as well as can be freely and fairly traded throughout the EU. The impact of this regulation can alter the operations of medical device manufacturers most notably on the supply chain and quality management systems of the organizations. It is critical that industry takes steps now to prepare their organizations and start implementing changes.

Data Integrity

Data integrity continues to be a priority and a hot topic. Regulators are focused to detect data integrity, data manipulation, and fraud. They must be able to rely upon the accuracy and completeness of the data and information generated, providing assurances to the products’ safety, identity, strength, purity, and quality which are all dependent on the validity of the data and information obtained.


Regulators are gaining more control and oversight of the medical devices industry. They are taking steps to prepare for the new innovations and enhanced capabilities of diagnosis and treatment with medical devices. It is important for medical device companies to proactively prepare for these changes as their impact could be significant. These include impacts on the cost of implementing changes to organizational prioritization and to internal processes around device accountability/supply, source, availability, and quality. If industry and regulators continue to maintain their role of ensuring compliance, new innovative devices can be made available, safely and effectively for patients, providing for better healthcare outcomes.

[1] US Food & Drug Admin., Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices, 83 Fed. Reg. 7366(Feb. 21, 2018) (hereinafter Medical Device Rule).

[2] See 21 C.F.R. §§ 50, 56, 812.

[3] 21 C.F.R. § 812.27(b)(4)(ii).

[4] Medical Device Rule at 7370.

Posted in Issue of the Month, Medical Devices and tagged .