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The recommended format provided in this document aims to establish uniformity in reporting CM&S studies. FDA recognizes that the level of detail to be reported will vary and will depend on the context of use for the CM&S studies. Moreover, there are a variety of CM&S modalities and thus the specific details will vary across disciplines. Therefore, we have provided a general outline in the main body of this document and five subject matter appendices for CM&S modalities that are widely used in regulatory submissions. The main body is written in general terms to capture reporting for any modality. The five appendices provide more background, structure, and specific terminology for the following subject areas:
I. Fluid Dynamics and Mass Transport
II. Solid Mechanics
III. Electromagnetics and Optics
IV. Ultrasound
V. Heat Transfer

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This document recommends what to include in a 510(k) submission for display devices in diagnostic radiology as identified by their classification regulation (21 CFR 892.2050) and product code (PGY). These devices are classified as class II devices that are intended to be used in controlled viewing conditions to display and view digital images for primary image interpretation. Display devices for diagnostic radiology may also be referred to as soft-copy displays or medical grade monitors.

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Information from IVD tests form a significant proportion of all EHRs. Laboratories commonly associate a LOINC® (Logical Observation Identifiers Names and Codes; owned, developed, and curated by the Regenstrief Institute)1 code with each test being performed by a laboratory.

For each IVD test, LOINC provides a unique numeric code associated with test attributes that identify the type of IVD test such as the component, property, time, system, scale and method.2 At present, LOINC is the IVD coding system that is most widely used by clinical laboratories and EHRs, and is the IVD coding standard recommended by the Office of the National Coordinator for Health Information Technology (ONC) in the U.S. Department of Health and Human Services (HHS) as an essential part of meaningful use. LOINC is a partially FDA-recognized consensus standard, where the recognition is limited to IVD tests.

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The information presented in this document is intended to provide De Novo requesters with transparency regarding the types of information FDA believes are necessary to conduct a substantive review for a De Novo request.

This document includes both an Acceptance Checklist (Appendix A. Acceptance Checklist for De Novo Classification Requests) as well as a Recommended Content Checklist (Appendix B. Recommended Content Checklist for De Novo Classification Requests)

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The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA. Because the source
data2 are necessary for the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs, and medical devices, this guidance is intended to assist in ensuring confidence in the reliability, quality, and integrity of electronic source data and source documentation (i.e., electronic records).

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This guidance provides recommendations on the following:

  • How to decide which adverse reactions or other potential safety hazards are significant enough to warrant inclusion in the warnings and precautions section; what information to include when describing those adverse reactions; and how to organize the warnings and precautions section.
  • What situations warrant a contraindication; what information to provide in those  situations when the use of the product is contraindicated; and how to organize the contraindications section
  • When to include a boxed warning; and what information to include in the boxed warning section

 

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This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY section of prescription drug labeling (henceforth referred to as labeling) to meet regulatory requirements and ensure appropriate consistency in the format and content of this section for all prescription drugs approved by FDA.2,3 The guidance provides recommendations to applicants submitting new drug applications (NDAs) (including applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)), abbreviated new drug applications (ANDAs), supplements to approved NDAs, biologics license applications (BLAs), and supplements to BLAs, who intend to prepare or amend the clinical pharmacology information in the labeling for human prescription drugs.

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