Description
This document supersedes Guidance on the Content and Format of Premarket Notification [510(k)]Submissions for Liquid Chemical Sterilants and High Level Disinfectants, December 18, 1997
Scope & Applicability
Product Classes
9Products used for processing reusable medical devices; used to process reusable critical and semicritical medical devices; liquid chemical sterilants/high level disinfectants are for use with critical and semicritical devices; guidance for premarket notification of liquid chemical sterilants; labeled for reuse requiring chemical indicators; Products intended for sterilization of medical devices
devices making only topical contact with intact skin
devices contacting intact mucous membranes
devices introduced directly into the bloodstream or sterile tissue
Products used for processing reusable medical devices; used to process reusable critical and semicritical medical devices; liquid chemical sterilants/high level disinfectants are for use with critical and semicritical devices; guidance for premarket notification of high level disinfectants; labeled for reuse requiring chemical indicators; Products intended for high level disinfection of medical devices
intended for sterilization of reusable heat sensitive critical medical devices; Subject of the premarket notification guidance; product intended to sterilize reusable heat-sensitive medical devices; Device type eligible for Special 510(k)
germicide that inactivates all microbial pathogens except large numbers of bacterial endospores; Subject of the premarket notification guidance; germicide intended to disinfect reusable heat-sensitive medical devices; product with both device sterilization and high level disinfection claims; Device type eligible for Special 510(k)
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
exempted from 510(k) requirements
Stakeholders
9Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for implementing biosecurity and pest control; Entity responsible for cleaning, disinfection, and sampling; entity responsible for sampling, testing, and recordkeeping; The entity responsible for providing records within 24 hours of request
The person in the firm required to submit the premarket notification.
Entity responsible for submitting NDINs
user should be adequately trained in the reprocessing of medical devices
Entity responsible for submitting NDINs
Trading partner required to have verification systems; Trading partner required to have verification systems in place.; Trading partner required to validate transaction history and verify product identifiers; must quarantine illegitimate product; receives returned product that it intends to further distribute
Entity responsible for submitting applications under section 524B
convened to classify disinfectants
Regulatory Context
Attributes
10Standard for 510(k) clearance
Weight percentages for components in a formulation
Safety characteristic of the formulation
Intrinsic characteristic affecting the growth of L. monocytogenes; intrinsic characteristic used as a process control; parameter to monitor for control; Process control parameters such as pH; Used to define listeristatic formulations
Data required for germicide comparison
Verify the germicide effectiveness under worst case conditions
monitoring the MEC or MRC of the product active ingredient; Minimum Recommended Concentration of the active ingredient
monitoring the MEC or MRC of the product active ingredient; Minimum Effective Concentration of the active ingredient
information on whether the germicide damages device materials
Determined based on stability data; Established through stability testing; also called dating period.; Established through formal stability studies; Establishing the period during which a drug product is expected to remain within specifications; Period for drug products; The period during which a drug product is expected to remain within specifications; Duration product remains within acceptance criteria; Period during which product remains within specifications; Established for intermediates pu
Identified Hazards
Hazards
5Environmental factors affecting biological products
potential safety hazard warning in labeling
discoloration, corrosion, cracking, crazing, and embrittlement
inoculum used to test the efficacy of the germicide
L. monocytogenes is known to form biofilms on food contact surfaces
Related CFR Sections (13)
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead 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 →
- 21CFR801.15§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →
- 21CFR801.6§ 801.6 Medical devices; misleading statements.
Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.Read full regulation →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead full regulation →
- 21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR807.85§ 807.85 Exemption from premarket notification.
(a) A custom device is exempt from premarket notification requirements of this subpart if the device is within the meaning of section 520(b) of the Federal Food, Drug, and Cosmetic Act.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)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Kit Certification for 510(k)s (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)