NCQM — National Committee for Quality Management

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Industry reference

Medical Devices & Diagnostics

Intended use and device classification guide the regulatory pathway. Quality management, premarket evidence, labeling and postmarket obligations address different parts of the device life cycle and should be assessed together without treating any single certificate as comprehensive approval.

A product-specific review

Move from scope to evidence

  1. Define the product and activity

    Define intended use, indications, users, operating environment and device classification. Establish the relevant premarket pathway or exemption and any limitations. For diagnostic products, the specimen, analyte, intended population and interpretation of results are material parts of the product definition.

  2. Connect requirements to evidence

    Relate QMSR controls to design and development, suppliers, production and the evidence supporting the device. Review recognized consensus standards for their exact recognition scope and edition. A test report can address a technical characteristic without resolving the entire submission or quality system question.

  3. Review interfaces and changes

    Review identification, labeling, reporting and other postmarket obligations separately. Assess product and manufacturing changes against the applicable pathway. FDA establishment registration or device listing should not be presented as a general statement that the agency has approved the device.

8 source profiles

Requirements and technical resources

Review the references relevant to your product and activity. This selected federal collection does not replace a separate review of applicable state, local or contractual requirements.

Recognition or voluntary programFDA

FDA Recognized Consensus Standards for Medical Devices

FD&C Act section 514(c); FDA Recognized Consensus Standards Database

FDA recognizes consensus standards for specified uses in medical device premarket review. The recognition record identifies the standard and relevant conditions, including complete or partial recognition. Recognition is distinct from incorporation into regulation and from approval or clearance of a device. A manufacturer must connect the selected edition and recognized provisions to the intended device and the evidence submitted.

Medical Devices & Diagnostics

Federal regulationFDA

Human Cells and Tissues: Part 1271 and Tissue Practices

21 CFR Part 1271; PHS Act sections 351 and 361

Part 1271 addresses human cells, tissues, and cellular and tissue-based products, or HCT/Ps. It establishes requirements concerning registration, donor eligibility, tissue practices and records. Regulatory treatment depends on the product and its intended use, including minimal manipulation and homologous use. Meeting registration requirements does not establish that a product qualifies for regulation solely under section 361 or has FDA marketing approval.

Pharmaceuticals & BiologicsMedical Devices & Diagnostics

Federal regulationFDA

In Vitro Diagnostic Products: Labels and Instructions

21 CFR Part 809, especially section 809.10

Part 809 establishes labeling provisions for in vitro diagnostic products for human use. Immediate-container labels and accompanying instructions serve different functions. Intended use, specimen requirements, procedure, limitations and performance information must correspond to the actual product. Research-use and investigational-use statements are conditional regulatory categories, not alternative labels that make a clinical diagnostic product exempt from premarket requirements.

Medical Devices & Diagnostics

Federal regulationFDA

Laser Products: Radiation Performance and Manufacturer Certification

21 CFR 1040.10 and 1040.11; related Parts 1002 and 1010

Laser products can be subject to federal radiation performance standards as well as records, reports and manufacturer-certification requirements. Product classification, accessible emissions, protective features, labeling and user information affect the analysis. Medical lasers also raise medical-device obligations. An FDA report accession number acknowledges a report; it is not product approval or a substitute for evidence supporting the manufacturer’s certification.

Radiation-Emitting ProductsMedical Devices & Diagnostics

Federal regulationFDA

Medical Devices: 510(k) Premarket Notification

21 CFR Part 807, Subpart E; FD&C Act section 510(k)

The 510(k) pathway evaluates substantial equivalence to a legally marketed predicate device. Device classification, intended use, technological characteristics and exemption limitations determine whether the pathway is available and what evidence is needed. FDA clearance permits marketing under the reviewed conditions but is not the same regulatory decision as premarket approval. Establishment registration and device listing do not confer clearance.

Medical Devices & Diagnostics

Federal regulationFDA

Medical Devices: Quality Management System Regulation

21 CFR Part 820; ISO 13485:2016 incorporated by reference

The Quality Management System Regulation is the current FDA device CGMP framework, effective February 2, 2026. Part 820 incorporates ISO 13485:2016 by reference with FDA-specific provisions and definitions. Manufacturers must consider the complete regulatory framework rather than treating a third-party ISO certificate as an FDA approval. FDA also changed its device inspection approach when QMSR became effective.

Medical Devices & Diagnostics

Federal regulationFDA

Medical Devices: Unique Device Identification and GUDID

21 CFR Part 830; related labeling provisions in 21 CFR Part 801

The UDI framework links a device identifier on labels and packages with specified information submitted to FDA’s Global Unique Device Identification Database. The labeler has responsibilities that can differ from the legal manufacturer’s role. Device identifiers and production identifiers serve separate purposes. Exceptions, direct-marking requirements and applicable compliance policies must be assessed for the specific device rather than inferred from a barcode alone.

Medical Devices & Diagnostics

Reference resourceNIST

Metrological Traceability and Measurement Evidence

NIST Policy on Metrological Traceability

Measurement evidence depends on more than an instrument’s calibration label. NIST explains traceability as the relationship of a measurement result to a reference through a documented chain of calibrations, with contributions to uncertainty. The result must also be suitable for the decision being made; traceability alone does not establish adequate accuracy for a particular product requirement.

Industrial Machinery & Electrical EquipmentMedical Devices & DiagnosticsGovernment Procurement & Technical Supply

Build a defensible review record

Identify the product configuration, the controlling provision and edition, the evidence required and the person authorized to make the decision. Keep a reason for exclusions and unresolved questions alongside confirmed requirements.

Revisit the record when design, materials, suppliers, software, claims or the applicable source changes. An earlier report remains useful only to the extent that it supports the current configuration and requirement.

Practice guidance