Quality Terms (54)

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

A 510(k) pathway that relies on FDA guidance documents, recognized consensus standards, or special controls to establish substantial equivalence.

The substance in a pharmaceutical drug that is biologically active and produces the intended therapeutic effect.

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

The ability of a medical device material to perform its intended function without causing adverse biological response in contact with tissue, blood, or other body fluids.

The section of a regulatory submission describing a drug's composition, manufacturing process, and quality controls.

Low-risk medical devices subject to general controls and, in most cases, exempt from 510(k) premarket notification.

Moderate-risk medical devices subject to general controls plus special controls, typically requiring 510(k) premarket notification.

Highest-risk medical devices requiring Premarket Approval (PMA) based on clinical evidence of safety and effectiveness.

A therapeutic product combining two or more regulated components (drug, device, biologic) with a primary mode of action determining the lead FDA center.

An analytical method published in an official pharmacopoeia (USP, Ph. Eur., JP) that serves as the recognized standard for testing a specific article.

The planned set of controls, derived from product and process understanding, that ensures process performance and product quality.

A systematic approach to identifying, investigating, and addressing the root causes of quality problems.

A process parameter whose variability has an impact on a Critical Quality Attribute and therefore must be monitored or controlled to ensure product quality.

A physical, chemical, biological, or microbiological property of a drug substance or product that must be within an appropriate range to ensure quality.

The current quality standards FDA enforces for the manufacture, processing, packing, and holding of drug products to ensure identity, strength, quality, and purity.

A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.

Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.

The multidimensional combination of input variables and process parameters demonstrated to provide assurance of quality, enabling operational flexibility within the defined region.

A departure from an approved procedure, specification, or established standard during manufacturing or testing.

FDA's interactive PDF template required for all 510(k) submissions and extended to De Novo classification requests.

Inorganic impurities, principally heavy metals, that may be present in drug products and require assessment under ICH Q3D.

Analytical testing to quantify bacterial endotoxins in parenteral drugs, medical devices, and other products where endotoxin presence could cause pyrogenic reaction.

The EU GMP annex establishing requirements for the manufacture of sterile medicinal products.

The EU GMP annex establishing requirements for computerized systems used in GMP-regulated activities.

An inactive substance used as a carrier or vehicle for the active pharmaceutical ingredient in a drug product.

The quality system covering the organizational process and conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, and reported.

Regulations ensuring pharmaceutical products are consistently produced and controlled according to quality standards.

The application of usability knowledge to medical device design to minimize use-related hazards and support safe, effective operation.

The ICH guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

The international standard defining software lifecycle processes for medical device software.

A medical device used to perform tests on samples taken from the human body to detect diseases, conditions, or infections.

FDA authorization allowing an unapproved medical device to be used in a clinical investigation to collect safety and effectiveness data.

The international standard for application of risk management to medical devices across the full product lifecycle.

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

A class of genotoxic impurities that can form during drug substance or drug product manufacturing and require risk assessment and control.

A test result that falls outside the established acceptance criteria or specifications.

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

A framework for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes.

Documented evidence establishing high confidence that a process consistently produces a product meeting specifications.

Documented evidence that a process consistently produces a product meeting predetermined specifications and quality attributes.

FDA's formal mechanism for device sponsors to obtain feedback on development plans, submission content, or regulatory strategy before filing.

A written document defining the cGMP responsibilities and activities between a drug owner and contract manufacturer or testing facility.

A systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding.

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

A prospective summary of the quality characteristics a drug product should possess to deliver the intended therapeutic benefit to the patient.

FDA's decision not to accept a 510(k) submission for substantive review due to administrative or completeness deficiencies.

An expedited 510(k) pathway for device modifications made by the original manufacturer of a previously cleared device.

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

The FDA determination that a new medical device is as safe and effective as a legally marketed predicate device, allowing 510(k) clearance.

The formal process of evaluating and approving suppliers of materials, components, and services used in GMP-regulated manufacturing.

The documented process of moving manufacturing technology and knowledge from one site or party to another to enable production at the new location.

The standard 510(k) premarket notification pathway for Class II devices demonstrating substantial equivalence to a predicate.

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.