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As artificial intelligence continues to evolve, we are seeing revolutionary opportunities to enhance health care, especially through machine learning. AI can be applied across the spectrum of health applications, including for the prevention, diagnosis, and treatment of a variety of medical conditions, as well as for a range of administrative tasks. Health products, including those that are medi..

In recent years, the FDA has embarked on an ongoing journey to develop a premarket review approach for artificial intelligence (AI)/machine learning (ML) software modifications. This journey included the Agency’s 2019 discussion paper and request for feedback on the proposed regulatory framework, several workshops to gather inputs from various stakeholders, as well as the Agency’s action plan re..

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which outlines the agency's commitment and cross-center collaboration to protect public health while fostering responsible and ethical medical product..

The US Food and Drug Administration (FDA) has begun issuing export documents for medical devices in electronic format in order to help streamline processes and reduce time and effort for manufacturers seeking to sell their products in non-US markets. A letter to industry from FDA explains that the agency’s transition to electronic formats took effect January 2, 2024, and applies to documents suc..

Each year, the Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents that it intends to publish during the fiscal year. These lists are: The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year. The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal y..

This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable pathogen, or determine genetic carrier status. Nucleic ..

미국 FDA (식품의약품안전처) 내부 CDRH 부서에서 국제규격과 미국 내부 규정과의 조화 (harmonization)를 위한 계획안을 발표하였다 (draft strategic plan). ▶ Mission It is CDRH's mission to protect and promote the US public health. From an international perspective, this means integrating the US into the international medical device ecosystem. To do so, we develop and foster relationships with other regulatory authorities and strategic partners..

FDA에서 'Digital Health' 제품관련 자주하는 질문에 대한 공식적인 답변을 게재 12개 자주하는 질문에 대해 답변 Digital Health Frequently Asked Questions (FAQs) | FDA Digital Health Frequently Asked Questions (FAQs) We encourage you to review our list of FAQs on this page and explore the FDA’s many publicly available resources online to help answer your general questions. www.fda.gov