Substantial Equivalence
What does NSE stand for?
Not substantially equivalent
How many days does the FDA have to decide if your device is substantially equivalent?
90 days.
A device the successfully passes the FDA 510(k) process is considered "FDA _______".
Cleared.
What does AES stand for?
Advanced Encryption Standard.
What is an attack that aims to make a computer or network service unavailable to users by overwhelming it with traffic?
Denial of Service.
Substantial equivalence must be demonstrated in terms of what two key aspects?
Intended use and technological characteristics.
When specifically does the FDA 90-day clock start?
When the FDA accepts your submission for review.
eSTAR.
True or False. In asymmetric key cryptography, the public key used to encrypt data is the same key used to decrypt the data.
False.
In asymmetric encryption, the public key encrypts data, and a private key is used to decrypt it.
What tool is used to monitor and control incoming and outgoing network traffic based on predetermined security rules?
Firewall.
True or False. In a 510(k), manufacturer can use one predicate device to support the intended use of their device and a different predicate device to support its technological characteristics (ie: a split predicate)
False.
What commonly encountered scenario pauses the FDA's clock?
Additional Information Request.
A public document submitted in the 510(k) process that outlines the substantial equivalence of a device to a predicate is called __________________.
510(k) Summary.
What cryptographic algorithm is often used in digital signatures to verify the authenticity of a message?
RSA or ECDSA.
True or False. WPA2 is more secure than WEP for wireless network encryption.
True.
WPA2 is significantly more secure than WEP (Wired Equivalent Privacy) for wireless network encryption. WPA2 uses AES (Advanced Encryption Standard), which is much stronger than the weak encryption used by WEP.
True or False. A 510(k) submission can demonstrate substantial equivalence using a predicate that is no longer actively marketed but has not been formally withdrawn or recalled.
True.
A predicate device that is no longer actively marketed can still be used, as long as it has not been withdrawn or recalled for safety or effectiveness reasons.
180 days.
A formal notification from the FDA to a manufacturer about violations of regulations that could lead to enforcement actions is called ___________________.
FDA Warning Letter.
Which hash algorithm is more vulnerable to collision attacks: MD5 or SHA-1?
MD5. It's shorter and has other cryptographic properties that make it more prone to collisions.
Note: Both are older algorithms and considered less secure than SHA-256 or SHA-3.
What does DNS stand for?
Domain Name System
True or False. If an earlier predicate (a predicate of a predicate) was recalled, it automatically disqualifies the newer predicate from being used to demonstrate substantial equivalence. Under latest FDA guidelines.
False.
A recalled earlier predicate does not automatically disqualify a newer predicate. As long as the newer predicate itself has not been withdrawn or recalled for safety or effectiveness reasons, it can still be used to demonstrate substantial equivalence. However, the FDA may scrutinize whether the safety issues from the earlier predicate affect the newer predicate or the device in question.
True or False. If the FDA issues multiple Additional Information (AI) holds for a 510(k) submission, the 180-day response period for each hold is added together to extend the FDA's total 90-day review clock.
False.
The 180-day response period for AI holds is separate from the FDA’s 90-day review clock, which does not get extended. The clock is paused during AI holds and resumes from where it left off once the FDA receives the requested information, but it doesn’t add up the days for multiple holds.
When a medical device undergoes a detailed evaluation that includes ensuring the device materials will not cause harm to the patient, it is referred to as __________ testing, which is critical for devices that come into direct contact with the human body.
Biocompatibility
What is a random number used only once to prevent replay attacks in cryptographic protocols?
The nonce.
The Heartbleed bug was a vulnerability in the OpenSSL package with a CVSS score of 10.0 (Critical). Which version of OpenSSL was this bug patched in?
OpenSSL 1.0.1g