21 Cfr 809 (2024)

1. 21 CFR Part 809 - eCFR

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(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 requirement made by or under authority of this act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.”

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES. PART 809, IN VITRO ...
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PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart B - Labeling. Sec. 809.10 Labeling for in vitro diagnostic products. (a) The label for an in ...
(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 requirement made by or under authority of this act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."

(a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a ...
(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 requirement made by or under authority of this act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."

PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE · Subpart A—General Provisions; § 809.3 Definitions. 21 CFR § 809.3 - Definitions. CFR; Table of Popular ...
§ 809.3 Definitions.

21 CFR 809 - In-Vitro Diagnostic Products. 10Part809-1.jpg 1-933734-46-9. US FDA Title 21 CFR Parts. Part 809 - In Vitro Diagnostic Products for Human Use ...
GMP Publications, Part 809 - In-Vitro Diagnostic Products

29 sep 2023 · FDA is proposing to amend its regulations to make explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD ...
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PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart B - Labeling. Sec. 809.11 Exceptions or alternatives to labeling requirements for in vitro ...
(a) The appropriate FDA Center Director may grant an exception or alternative to any provision listed in paragraph (f) of this section and not explicitly required by statute, for specified lots, batches, or other units of an in vitro diagnostic product for human use, if the Center Director determines that compliance with such labeling requirement could adversely affect the safety, effectiveness, or availability of such products that are or will be included in the Strategic National Stockpile.

21 CFR 809 In Vitro Diagnostic Products for Human Use with TOC. Posted on March 20, 2022 April 20, 2022 by QS Compliance. View in Full Screen. Page 1 / 13.
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Browse Code of Federal Regulations | PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE for free on Casetext. ... Title 21 - FOOD AND DRUGS CHAPTER I - FOOD ...
Browse Code of Federal Regulations | PART 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE for free on Casetext

PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart C - Requirements for Manufacturers and Producers. Sec. 809.30 Restrictions on the sale ...
(a) Analyte specific reagents (ASR's) (§ 864.4020 of this chapter) are restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set forth in this section.

25 okt 2007 · This is not an all-inclusive list. Title 21, Code of Federal Regulations (21 CFR) ... 21 CFR Part 809, In Vitro Diagnostic Products for Human Use, ...

PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart C - Requirements for Manufacturers and Producers. Sec. 809.20 General requirements for ...
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PART 809 -- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE. Subpart C - Requirements for Manufacturers and Producers. Sec. 809.40 Restrictions on the sale ...
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14 aug 2017 · I know that 21 CFR 809.10 states there needs to be a lot number in the immediate container of an IVD medical device.
I know that 21 CFR 809.10 states there needs to be a lot number in the immediate container of an IVD medical device. Does anybody know whether or not there needs to be a lot number or expiration date on the secondary packaging. The CFR code does no explicitly state it does for secondary...