Standards and Guidances for Neurological Devices

Established standards, guidance documents, and other requirements are an important part of the device development process.

Standards

To make the review process comprehensive and predictable, the FDA recognizes certain standards developed by organizations such as the International Organization for Standardization (ISO) and American Society for Testing and Materials (ASTM) International.

Sponsors can find FDA recognized national and international standards related to neurological devices by selecting the "Neurology" category under Specialty Task Group Area of the FDA Recognized Consensus Standards database.

Guidance Documents

Guidance documents represent the FDA's current thinking on a particular subject. They provide recommendations on fulfilling FDA's regulations and describe expectations for developing and monitoring medical devices. FDA guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if it satisfies the requirements of the applicable statute, regulations, or both.

Sponsors can find FDA guidance documents related to neurological devices by selecting "Neurological Devices" in the subject field of FDA's Search for Guidance Documents database.

Additional Recommendations

Neurological devices have unique characteristics that require special study. Sponsors can familiarize themselves with the following standards and guidance to help them demonstrate the safety and effectiveness of their medical device:

Biocompatibility Evaluation

Biocompatibility of a medical device refers to the ability of the device to bring about the desired biological response without causing any negative or harmful effects in the body. Biocompatibility depends on the body's responses to the device as well as the device's responses to the physiological environment inside the human body.

Relevant Standards:

• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Animal Studies

Animal studies, while not always necessary, are intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption [IDE] application, or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies).

The FDA recommends that animal studies be conducted in accordance with Good Laboratory Practice (GLP) as outlined in CFR 21§58.0 (GLP Regulations).

Sterility

Sterility of medical devices should be validated to assure appropriate assurance levels. For detailed information about sterilization processes for 510(k)s for devices labeled as sterile, refer to the following consensus standards and FDA Guidance:

FDA Guidance Related to Sterility:

• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

Relevant Standards:

• AAMI ANSI ISO 11135:2014: Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of sterilization process for medical devices.
• AAMI ANSI ISO 11137-1:2006/(R)2010: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
• ISO 17665-1 First edition 2006-08-15: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013: Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• ISO 10993-7 Second edition 2008-10-15: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

Pyrogenicity

The Agency recommends that devices meeting pyrogen limit specifications be labeled "non-pyrogenic." We recommend that sponsors refer to the following consensus standards and guidance document for additional guidance on LAL testing:

FDA Guidance Related to Pyrogenicty:

• Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers (June 2012)
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Relevant Standards:

• AAMI ANSI ST72:2011: Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
• USP<161> Medical Devices - Bacterial Endotoxic and Pyrogen Tests