| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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6-513
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| Standard | |
ISO 14607 Fourth edition 2024-12
Non-active surgical implants - Mammary implants - Specific requirements |
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Scope/Abstract| This document specifies specific requirements for mammary implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization and information supplied by the manufacturer. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
* Note in Subclause 11.8.2 Patient Information Brochure
* Subclause 7.2.1 General
* Subclause 7.2.5 Biological Evaluation |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because:
* The NOTE in Subclause 11.8.2 is in conflict with an existing law Section 515(d)(1)(B)(ii) of the Food, Drug, and Cosmetic Act, U.S. Code Title 21 (See "Relevant Public law, CFR Citation(s) and Procode(s)" section below). Please note that breast implants are a restricted device with specific restrictions given authority by Section 515(d)(1)(B)(ii) of the Food, Drug, and Cosmetic Act. All breast implant approval orders and current PMA Supplements contain the language (See Ref #1 below for an example).
* Subclause 7.2.1 is in conflict with an existing published final guidance (See Sections IV.A, IV.C, IV.E, IV.G, IV.H, V.A, V.C of Ref #2 below).
* Subclause 7.2.5 is in conflict with another recognized standard ISO TS 10993-20:2006 (See Ref #3 below) and a published final guidance (See Attachment A and Section III. C of Ref #4 below). Please note that FDA only partially recognizes ISO TS 10993-20:2006 by excluding Annex C from recognition.
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.3530 |
Prosthesis, Breast, Inflatable, Internal, Saline
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Class 3
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FWM
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| §878.3540 |
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
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Class 3
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FTR
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| N/A |
Tissue Expander And Accessories
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LCJ
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| United States Code, Title 21, (515(d)(1)(B)(ii) |
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Relevant FDA Guidance and/or Supportive Publications*
1. FDA Approval Order for P23005, September 2024.
2. Guidance for Industry and Food and Drug Administration Staff: Saline, Silicone Gel, and Alternative Breast Implants, issued September 2020.
3. ISO TS 10993-20 First edition 2006-08-01 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices. (Recognition number 2-240)
4. Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, issued September 2023.
5. Guidance for Industry and Food and Drug Administration Staff: Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, issued September 2020.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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| FDA Technical Contacts
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| Standards Development Organization
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FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
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