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Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff

FinalCenter for Devices and Radiological Health06/02/2004
Process ValidationQuality Systems auditDesign ValidationDesign ControlInstallation QualificationOperational QualificationPerformance Qualification

Description

Thisguidance documentdescribes the types of validation data that FDA recommends be submitted under section 510(o) of the Act. In addition, it provides guidance to industry and FDA staff on submission and review procedures for validation data in 510(k)s for reprocessed SUDs. This guidance supersedes the guidance of the same title, issued June 1, 2004. In this revised version, we clarify the use of FDA-recognized standards and the applicability of the Special 510(k) Program to 510(k)s submitted with validation data. We also clarify the obligations of an OEM who reprocesses SUDs. Lastly, the 2004 document addressed initial MDUFMA implementation issues; many of which are no longer relevant and have been removed. If, in the future, additional device types are added to the list of reprocessed SUDs requiring validation data, a Supplemental Validation Submission (SVS) will be required for those devices and this guidance will provide information on the type of validation data that should be submitted.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

7
Reprocessed Single-Use Medical Devices

Guidance on validation data for premarket notification submissions

Critical reprocessed SUDs

Devices no longer exempt from 510(k) submission requirements

Semi-critical reprocessed SUDs

Devices identified as no longer exempt from 510(k) requirements in 2004

Reprocessed SUDs

Single-use devices that have been subjected to additional processing for an additional single use.

Critical reprocessed single-use device

Reprocessed SUD intended to contact normally sterile tissue or body spaces.

Semi-critical reprocessed single-use device

Reprocessed SUD intended to contact intact mucous membranes.

Reprocessed Single-Use Medical Device

Subject of the guidance document; Subject of the guidance regarding validation data

Stakeholders

4
Reprocessor

Entity that replaces or saves components during reprocessing

Original Equipment Manufacturer

Entity that established original safety and performance specifications

Reprocessors

Manufacturers who reprocess single-use devices

Original Equipment Manufacturers

Entities that manufacture the original, non-reprocessed device.

Regulatory Context

Regulatory Activities

4
510(k)

Premarket notification submission type

Special 510(k) Program

Applicability to 510(k)s submitted with validation data

Special 510(k)

FDA recommends you submit a Special 510(k)

PMA

Premarket Approval Application

Document Types

4
Supplemental Validation Submission

Required if additional device types are added to the list; Submission of validation data for an already cleared 510(k)

Material Safety Data Sheets

Documents FDA does not intend to enforce submission for if unaltered

Federal Register Notice

Published to seek public comment on withdrawal proposals

Master File

Documentation artifact related to NDI notifications

Attributes

3
Substantial Equivalence

Standard for 510(k) clearance

Shelf life

Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life

Sterility Assurance Level

Quality parameter that must remain unchanged for the policy

Technical Details

Substances

2
Ethylene Oxide

sterilization facilities that use a gas called ethylene oxide (EtO) to sterilize medical devices; Common method of terminal sterilization of medical devices; sterilization facility change involving EtO; Sterilant used in the manufacturing process

Cleaning agents

Includes enzymes, water, rinses and detergents used in reprocessing

Testing Methods

3
Pyrogen Tests

Required validation data for reprocessed devices; Conducted during process definition and routine monitoring

Toxicological tests

Used to provide summary data on the safety of cleaning agents

Functional Performance

Data demonstrating device remains SE to predicate after reprocessing

Processes

3
Cleaning

Techniques to remove soil, food residue, and dirt from FCS.

Aseptic Processing

implied manufacturing process under QS regulation

Sterilization

Required for contaminated equipment and media before disposal

Identified Hazards

Hazards

2
Microbiological Contamination

Environmental factors affecting biological products

Pyrogens

Residuals that must be assessed for devices contacting blood

Standards & References

External Standards

1
FDA-Recognized Standards

Use of standards in validation data submissions

Specifications

3
Substantial Equivalence

The standard for clearing a 510(k) submission against a predicate device.

Cleaning endpoint

Objective and measurable specification for a clean device

Acceptance Criteria

limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests

View on FDA.govDownload PDF

Related CFR Sections (1)

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)
21
Misbranded under section 502(o)
19
Failure to establish and maintain procedures to control the design of the device
10
Failure to adequately develop, maintain, and implement written MDR procedures
10
Failure to establish and maintain procedures for implementing corrective and preventive action
10
Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints
8
Unapproved Device Violations
8
Failure to establish and maintain procedures for implementing corrective and preventive actions
8
Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints
8
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures
7

Recent Cases

Related Warning Letters (10)

Related MFDS Guidelines

Korean regulatory guidelines covering similar topics

See Also (8)