Description
This guidance describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH. Specifically, this guidance describes the framework for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. CDRH believes that MDDTs will facilitate the development and timely evaluation of medical devices by providing a more efficient and predictable means for collecting information to support regulatory submissions and associated decision-making.
Scope & Applicability
Product Classes
3FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Synonymous with drugs, medicines, medicinal products, vaccines, and biological products.; Product intended to benefit population groups once authorized; The product being tested in the clinical trial.; The product being studied in the clinical trial.; monitoring extent based on the nature of the investigational product; Management, storage, and accountability of the product being tested.; management should be arranged and conducted in accordance with applicable regulatory requirements; The produ
Devices requiring full IDE submission
Stakeholders
5The entity providing information for the AFIC process.
Voluntary users of qualified MDDTs in regulatory submissions.; Entity using qualified MDDTs for device development
Entities that develop and submit tools for qualification.
We recommend that the COU be conveyed prominently when a tool developer offers its MDDT.; Entity developing and submitting MDDTs for qualification
Tool developer offers its MDDT to medical device manufacturers.
Regulatory Context
Attributes
6The specific environment and population in which a COA is intended to be used; Selecting fit-for-purpose COAs based on the context of use.; The intended context in which the COA will be used
Cybersecurity is part of device safety and effectiveness
Standard for 510(k) clearance
Supported by data to show the test performs as intended.
reliability includes accuracy, completeness, and traceability
A component of precision validation; Reproducibility is assessed by means of an interlaboratory trial
Related CFR Sections (2)
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
Related Warning Letters (5)
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
See Also (8)
- Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry (Status: Draft)
- Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions (Status: Final)
- Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs (Status: Final)
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (Status: Draft)