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USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems

Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research released updated guidance on "Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act".


The term "cybersecurity" refers to the protection of medical devices from cyber attacks, and includes such measures as encryption, firewalls, access controls, and regular software updates to prevent harm to patients and protect sensitive data.

The term ‘cyber device’ means a device that—

  1. includes software validated, installed, or authorized by the sponsor as a device or in a device;

  2. has the ability to connect to the internet; and

  3. contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats.

Refuse to Accept (RTA) is a preliminary review process used by FDA to ensure medical device submissions contain necessary information. If they don't, the submissions will be refused until the deficiencies are addressed.


The purpose of this policy is to mitigate cybersecurity risks in medical devices and protect patients from harm caused by cybersecurity incidents. In addition to improving efficiency and quality, the policy reduces the need for additional information requests and delays in the approval process.


As part of the policy, manufacturers are required to submit certain types of information during their premarket submissions in order to address cybersecurity risks and to ensure that the FDA can evaluate these risks during the review process.


Click this LINK to know more in detail about the cybersecurity requirements.


Also check out this guideline on "Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions" which was also released earlier today (30 March 2023) that details recommendations for supporting premarket submissions of orthopedic nonspinal bone plates, screws, and washers.


These recommendations reflect current review practices and are intended to ensure consistency and facilitate efficient review of the orthopedic nonspinal bone plate, screw, and washer submissions.

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