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This Guide applies to the manufacture of APIs for medicinal products for both human and veterinary use. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered but should be performed in accordance with the principles and guidelines of GMP as laid down in national legislations and interpreted in the GMP Guide including its Annex 1.

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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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Manufacturers of custom-made medical devices in Ireland must register their custom-made medical devices and registered address with the Health Products Regulatory Authority.

Manufacturers of custom-made devices do not have to place the CE mark on such devices.

Each finished device should be accompanied by information supplied by the manufacturer to use and maintain the device properly, taking into account the training and knowledge of potential users.

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The registration is made to facilitate the Swedish Medicines Agency’s control of the medical technology products that have been CE-marked and placed on the market by the manufacturer. It is the manufacturer of a medical device that ensures that the products covered by the notification meet the applicable requirements in the Medical Devices Act and the Swedish Medicines Agency’s regulations.

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The purpose of the guideline is to clarify the criteria for qualification of software and apps as medical devices and to highlight the legislative requirements that medical device manufacturers must fulfil.

The purpose of a device is determined by the manufacturer and not by virtue of how it is applied by the users. For example, an app intended to monitor the heart rate during exercise does not qualify as a medical device, not even if the user chooses to use the app for a medical purpose. In other words, it is the manufacturer who describes what the software/app is intended to be used for.

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