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FDA CDRH 가이던스 2025~2026 발행 목록 (29건·원문 링크)
FDA CDRH가 2025년 이후 발행한 가이던스 29건을 발행일·원문 링크와 함께 정리.
미국 FDA 의료기기·방사선보건센터(CDRH)가 2025-01-01 이후 발행한 가이던스 29건(최종·초안 포함)을 발행일 순으로 정리했다. 제목의 링크는 FDA 원문으로 연결된다. 국내 RA 실무에 영향이 큰 항목은 별도 분석글에서 다룬다.
📌 29건 중 무엇부터 볼 것인가 REGNA 편집 해석
미국 진출을 준비한다면 이 목록에서 먼저 열 것은 다음 넷이다.
- 인적요인(Human Factors) 최종 가이던스(2026-05-29) — 제출 유형이 위험도에 따라 3단계로 갈린다. 사용적합성 시험 계획을 언제 세우느냐가 일정 전체를 좌우한다.
- 시판전신고 면제 의향(2026-06-05) — 미분류 기기 일부를 510(k) 면제로 돌리려는 문서다. 자사 품목이 대상이면 진입 비용이 크게 준다.
- 임상의사결정지원(CDS) 소프트웨어 최종본(2026-01-29) — 소프트웨어가 «의료기기»에서 빠지는 경계를 다시 그었다. AI 기반 판독 보조를 만든다면 이 문서부터다.
- 정형 임플란트용 환자맞춤 가이드(2026-05-07) — 3D 프린팅·맞춤형 제작을 하는 곳에 해당한다.
나머지는 품목별 510(k) 제출자료 권고가 대부분이다. 자사 품목명이 제목에 있는지로 걸러 읽으면 된다. 국내 실무 영향이 큰 항목은 별도 분석 기사에서 다룬다.
| 발행일 | 구분 | 제목(원문 링크) |
|---|---|---|
| 06/05/2026 | Final | Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff |
| 05/29/2026 | Final | Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff |
| 05/07/2026 | Final | Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff |
| 04/20/2026 | Draft | Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff |
| 03/30/2026 | Final | Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties |
| 03/13/2026 | Final | Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff |
| 02/03/2026 | Final | Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff |
| 02/03/2026 | Final | Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff |
| 01/29/2026 | Final | Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff |
| 01/23/2026 | Draft | Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff |
| 01/06/2026 | Final | General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff |
| 12/18/2025 | Final | Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff |
| 12/03/2025 | Final | eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff |
| 10/28/2025 | Draft | Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff |
| 10/27/2025 | Draft | Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff |
| 09/23/2025 | Final | Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff |
| 08/22/2025 | Final | Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff |
| 08/18/2025 | Final | Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff |
| 07/31/2025 | Final | Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments |
| 06/06/2025 | Draft | Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff |
| 06/05/2025 | Draft | Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff |
| 05/29/2025 | Final | Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff |
| 05/29/2025 | Draft | Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff |
| 03/31/2025 | Final | Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff |
| 01/13/2025 | Final | Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff |
| 01/07/2025 | Final | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff |
| 01/07/2025 | Draft | Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration S |
| 01/07/2025 | Draft | Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff |
| 01/06/2025 | Draft | Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff |
출처: FDA CDRH Guidance Documents 데이터셋. 수집일 2026-06-11. 날짜는 FDA 표기(월/일/연) 원본.
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