Glossary

a submission requesting de novo classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act

[FDA 21CFR4]

an accounting method of allocating the cost of a tangible or physical asset over its useful life or life expectancy

Note: Depreciation represents how much of an asset's value has been used up. Depreciating assets helps companies earn revenue from an asset while expensing a portion of its cost each year the asset is in use.

[Investopedia]

overall plan for design and development activities for the particular medical device under consideration

change (modification) to product design or operations process design

process that increases the likelihood that the product design transferred to production translates into a medical device that meets its intended use (and user needs)

declaration that verification and validation activities are very likely to succeed using the current Device Master Record

a compilation of records which describes the design history of a finished device

[FDA 21CFR820]

the physical and performance requirements of a device that are used as a basis for device design

[FDA 21CFR820]

the results of a design effort at each design phase and at the end of the total design effort.  The finished design output is the basis for the device master record.  The total finished design output consists of the device, its packaging and labeling, and the device master record.

[FDA 21CFR820]

Note: Design outputs can be divided into two categories:
1.  Product Design Outputs (PDO) - design outputs pertaining to product design (i.e., medical device specifications, labeling specifications, packaging specifications)
2. Operations Design Outputs (ODO) - design outputs pertaining to operations process design (i.e., production process specifications, delivery process specifications, servicing process specifications)

a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems

[FDA 21CFR820]

the sum of activities that ensure that the device design is correctly translated into production specification

establishing by objective evidence that device specifications conform with user needs and intended use(s)

[FDA 21CFR820]

confirmation that the design output meets the design input requirements

[FDA 21CFR820 derived]

a compilation of records containing the production history of a finished device

[FDA 21CFR820]

a compilation of records containing the procedures and specifications for a finished device

[FDA 21CFR820]

Design Inputs, Design Outputs, Verification, and Validation

a process that destroys pathogens and other microorganisms by physical or chemical means. Disinfection processes do not ensure the same margin of safety associated with sterilization processes.

The lethality of the disinfection process may vary, depending on the nature of the disinfectant (See Appendix D), which leads to the following subcategories:
a. High Level Disinfection: A lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores.
b. Intermediate Level Disinfection: A lethal process utilizing an agent that kills viruses, mycobacteria, fungi and vegetative bacteria, but no bacterial spores.
c. Low Level Disinfection: A lethal process utilizing an agent that kills vegetative forms of 33 bacteria, some fungi, and lipid viruses.

[FDA guidance: Reprocessing Medical Devices...(2017)]

process to inactivate viable microorganisms to a level previously specified as being appropriate for a defined purpose

[ISO 11139:2018]

measures that ensure that the packaged medical device and associated components are handled, stored and transported such that product design specifications are preserved with identification and traceability maintained throughout distribution

information and the medium on which it is contained

Example: Record, specification, procedure document, drawing, report, standard.
Note 1: The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof.
Note 2: A set of documents, for example specifications and records, is frequently called “documentation”.
Note 3: Some requirements (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) and for records (e.g. the requirement to be retrievable).

[ISO 9000:2015]

(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

[OLRC 21USC9]