Description
Anin vitrocompanion diagnostic device (hereafter referred to as an “IVD companion diagnostic”) is anin vitrodiagnostic device (IVD) that provides information that is essential for the safe and effective use of a corresponding therapeutic product. As described in the FDA guidance entitled “In VitroCompanion Diagnostic Devices,” in most circumstances, an IVD companion diagnostic should be approved, granted ade novorequest or cleared by FDA contemporaneously with the approval of the corresponding therapeutic product for the use indicated in the therapeutic product labeling.
Scope & Applicability
Product Classes
4clinical trial involving a human drug and a companion diagnostic
IVDs that require an IDE application before use in a clinical trial.
used to confirm patients positive for the drug target
Includes therapeutic, preventive, and prophylactic drugs and biological products.; codevelopment of an IVD with a therapeutic product; identify a population expected to benefit from the therapeutic product; product used in conjunction with a companion diagnostic; therapeutic product and IVD sponsors may need to submit letters of authorization; coordination of the development programs of the two products; Product corresponding to an IVD companion diagnostic
Stakeholders
3Entity responsible for submitting applications under section 524B
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Governs top dose in clinical studies
Regulatory Context
Attributes
10High-risk devices generally requiring PMA.
A functional role of sodium in food
Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
Analysis by sex of clinical performance measures such as sensitivity
Estimated number of people with a disease, used to determine clinical investigation enrollment.
establishing the appropriate assay cutoffs to adequately define this population
prognostic marker would suggest that patients with the marker would have better or worse outcomes even absent treatment
predictive marker will predict that patients will have better or worse outcomes solely as a result of having received the investigational therapeutic product
Labeling for products used in clinical investigations.
Labeling for products not intended for diagnostic procedures.
Related CFR Sections (13)
- 21CFR809.3§ 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use 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 →
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR812.7§ 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:Read full regulation →
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 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 →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR812.119§ 812.119 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator (including a sponsor-investigator) has repeatedly or deliberately failed to comply with the requirements of this part, part 50 , or part 56 of this chapter , or has repeatedly or deliberately submitted to FDA or to the sponsor false informatRead full regulation →
- 21CFR312.42§ 312.42 Clinical holds and requests for modification.
(a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjectRead full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
See Also (8)
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff (Status: Final)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff (Status: Final)
- Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff (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)
- Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection (Status: Final)
- Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)