Description
The intent of thisguidance documentis to provide additional direction regarding information and data which should be submitted to FDA in a 510(k) submission for a sterilizer intended for use in a health care facility- Sterilizer technology is expanding at an accelerating pace.
Scope & Applicability
Product Classes
8Intended for Use in Health Care Facilities; Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities; Labeling for a sterilizer indicates the types of medical devices compatible with the process.
Standard sterilizers for which FDA accepts certification of performance for the 1/2 Cycle Test.
Special case for equivalent process times
Special case for equivalent process times
Table 2 lists test organisms for these devices; Sterilizers using multistep processes or new technology requiring well-defined validation steps.
Devices intended for use in health care facilities to eliminate microorganisms.; medical device subject to 510(k) submission intended for use in a health care facility
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
Type of sterilizer solely regulated by the EPA.
Stakeholders
2entity submitting marketing applications
Entity responsible for submitting NDINs
Regulatory Context
Attributes
10Regulatory standard for 510(k) clearance; demonstration required for 510(k) submission; regulatory standard for 510(k) clearance; Comparison of subject device parameters to predicate 510(k) submission numbers.
impact the biocompatibility of the device
A factor in all compatibility tests is the duration of compatibility, i.e. how many cycles an article can withstand.
Concentration of sterilant or by-products remaining on the medical product.
Sterility Assurance Level required for process validation.
Special case equivalent time at standard temperatures
Time required to destroy 90 percent of the vegetative cells or spores at a given temperature
Sterilization process equivalent time; Listed as an element in the biological test battery checklist.
most resistant organism to a sterilization process is used based upon determination of D-values
Sterility Assurance Level
Identified Hazards
Hazards
2Delays may create conditions favorable to microbial growth
Potential toxic profile of the agent and its by-products.
Related CFR Sections (4)
- 21CFR880.6860§ 880.6860 Ethylene oxide gas sterilizer.
(a) Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.Read full regulation →
- 21CFR880.6870§ 880.6870 Dry-heat sterilizer.
(a) Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat.Read full regulation →
- 21CFR880.6880§ 880.6880 Steam sterilizer.
(a) Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.Read full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (Status: Final)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (Status: Final)
- CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*) (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Testing Guidance for Male Condoms Made From New Material (Non-Latex) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)