On July 31, the ACC submitted comments to the U.S. Food and Drug Administration (FDA) regarding the agency's Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. The plan outlines current and future initiatives to update the regulatory processes for the development, approval and surveillance of medical devices regulated by the FDA.

The College's comments specifically address initiatives that would establish a robust medical device patient safety net in the U.S., explore regulatory options to streamline the timely implementation of post-market mitigations, spur innovation towards safer medical devices, advance medical device cybersecurity and integrate the Center for Devices and Radiological Health pre-market and post-market offices and activities.

While bringing new, innovative therapies to market is essential to furnishing high quality patient care, the FDA must retain patient safety as its number one priority by balancing the reduction of cost-inflating regulatory burdens with the need for regulatory decisions that protect patient interests and public health through rigorous scientific merit.

The College developed principles to guide the evaluation of regulatory efforts as the FDA continues to expand initiatives that refine oversight and promote innovation:

• Reduce the costs of new therapies and regulatory review by increasing regulatory harmony across federal agencies and standardizing best practices and data collection internationally.
• Encourage the use of standardized, accurate and reusable data sources, such as the National Cardiovascular Data Registry, to improve outcomes and increase access to valuable clinical data.
• Allow for flexibility in regulatory decision-making processes to accommodate the potential for rapid therapeutic advancements.
• Protect public health while fostering innovation by ensuring regulatory decisions are patient-centered and based on scientific merit.
• Provide patients with access to novel therapies while maintaining the high standard for safety and effectiveness.
• Take steps to ensure data used for regulatory decision-making is representative of affected patient populations; communicate data availability on the effects these therapies have on demographic subpopulations.
• Encourage the development of medical therapies designed for historically underrepresented patient populations.
• Collaborate with other federal agencies to monitor the impact of regulatory decisions on the drug pricing and supply landscape; swiftly address any concerns or adverse effects.
• Strengthen relationships with professional societies, academic partners and other stakeholders to further the field of regulatory science through consultation and communication.

The ACC will continue to provide feedback as the FDA moves forward with the implementation of these initiatives.

Keywords: ACC Advocacy, Equipment Safety, Patient Safety, Public Health, United States Food and Drug Administration, Computer Security, Data Collection, Information Storage and Retrieval, Radiologic Health, Registries, Decision Making, Referral and Consultation, Patient Care

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