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What is the name of the guidance that A’s issued for Medical Device Manufacturers?
General Principles of Software Validation
What are the majority of class I devices exempt from?
the premarket submission requirements
What is the FDA's classification of devices?
Some FDA classifi
What does a 510(k) exempt mean?
the manufacturer is not required to submit a premarket notification (i.e., a 510(k)) prior to marketing the device
What is the webpage that contains additional information about 510(k) exempt devices?
“Medical Device Exemptions 510(k) and GMP Requirements”
What is the process for determining whether a reader’s interpretation corresponds to the truth status established during the truthing process?
rationale, definition, and criteria
What is my app considered?
a mobile medical app
What are apps from a device manufacturer that provide information to support the company’s own device?
mobile medical apps
What is not considered on its own to be a device software?
Software used for data collection in clinical studies
What is the name of the FDA guidance document that contains Nonbinding Recommendations function?
FDA’s guidance related to use of computers
What is the name of the study that was issued on September 17, 2013?
Electronic Source Data in Clinical Investigations
What does ANSI stand for?
American National Standards Institute
What is the ISO 9001 Quality management system?
Requirements
What is the IEEE Standard for System, Software, and Hardware Verification and Validation?
IEEE Std 1012
What is the name of the Part 1 of the Guidance on the application of ISO 14971 to medical device software?
IEC/TR 80002-1
What is the part of the IEC 61508-2 that describes the Functional safety of electrical/electronic/programmable electronic safety-related systems?
Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems
What should you describe and fix before initiating your evaluation?
the scoring process
What is the name of the division that provides education about CDRH-regulated devices?
Division of Industry and Consumer Education (DICE)
What is the address of the Dockets Management Staff, Food and Drug Administration?
5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852
What is the address of the OCOD?
10903 New Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903
What is the address for De Novo Requests?
Address
What act was passed in 1995?
Paperwork Reduction Act of 1995
What is the purpose of this document?
to provide guidance on the process for the submission and review of a De Novo classification request
What does the De Novo classification process provide a pathway to?
class I or class II classification
What does CBER stand for?
Biologics Evaluation and Research
What is a device classified in class III and subject to premarket approval?
class III
What is the risk of a new type of device?
the device and the inability of general and special controls to provide reasonable assurance of the safety and effectiveness of the device
What is the physical overlap of the boundary, area, or volume of a reader mark in relation to the boundary, area, or volume of reference standard?
physical overlap
What is the level of risk they pose or the ability of general and special controls to assure safety and effectiveness?
level of risk
What was the process created by section 513(f)(2) of the FD&C Act referred to as in FDAMA?
Evaluation of Automatic Class III Designation
What had to be found in order to submit a De Novo request?
not substantiated
What is a premarket notification?
510(k)
What did FDA reclassify devices under?
section 513(e) of the FD&C Act
What is the name of the nonbinding recommendations currently available informatio?
Nonbinding Recommendations
What is the name of the subpart that FDA will use to assess whether a request for an evaluation of automatic class III designation is granted?
21 CFR Part 860, Subpart D--De Novo Classification
What is the name of the new section that FDA is updating to reflect the De Novo final rule?
513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff
What must the FDA make a classification determination for?
the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must describe the device and detailed information and reasons for any recommended classification
What is the subject of the De Novo request by written order within 120 days of receipt of the request?
the subject of the De Novo request
What should you describe when multiple readers are involved in scoring?
the number of readers involved, their qualifications, their levels of experience and expertise
What is the device in class III and may not be marketed unless the device i i?
the device i
What is the definition of a De Novo request?
a new De Novo request
What will FDA consider a De Novo request for?
devices that have already undergone 510(k) review
What should appear to meet the statutory standards for classification into class I or class II under section 513(a)(1) of the FD&C Act?
general controls or general and special controls would provide reasonable assurance of the safety and e
What allows FDA to provide feedback on whether a device may be eligible for the De Novo classification process?
A Pre-Sub
What is the purpose of a Pre-Sub?
to obtain feedback on the evidence, including non-clinical and/or clinical data, that will likely be necessary to support the De Novo request
What is a Pre-Sub?
A Pre-Sub
What will be handled in accordan?
De Novo Pre-Subs
What does the FDA search to establish that no legally marketed device and no classification regulation for the same device type exists?
public databases
What should clinical readers learn about the CADe device?
a description of the device and instructions for how to use the device
What should the Pre- Sub include in order for us to consider the specific questions?
Specific questions regarding review issues relevant to a planned De Novo request
What type of evidence do you anticipate providing in your De Novo request?
valid scientific evidence
What is the proposed mitigation measure(s)/control(s) for each risk based on?
the best available information at the time of the submission
What is the special use of a device?
mitigations
What are there other risks, in addition to those identified in the Pre-Sub?
identified in the Pre-Sub
What would be appropriate if additional biocompatibility and/or sterility testing were needed?
additional biocompatibility and/or sterility testing
What is the name of the document that describes meetings with FDA staff?
Q-Sub Guidance
What is the De Novo review process outlined in?
Attachment 1
What is the name of the website that provides information on vaccines and bloodbiologics?
CBER
What is the required content for a De Novo request?
21 CFR 860.220
What do you justify in your reading instructions?
clinical relevance
What is the eCopy program for Medical Device Submissions?
eCopy Program for Medical Device Submissions
What is the current mailing address for De Novo Requests?
current mailing address
What is the NSE of a device?
general controls or general and special controls may provide reasonable assurance of safety and effectiveness
What does the inclusion of this language within an NSE letter indicate?
given the risk profile of the device, it seems reasonable that De Novo classification may be appropriate
What is the criteria for whether a De Novo request should be reviewed?
11
What happens if your De Novo request is not accepted for review?
the review clock stops and we will notify you that it is on hold pending receipt of additional information
What is the deadline for FDA to complete the acceptance review?
15 days
What is the purpose of the De Novo classification process?
to analyze whether a likely predicate device exists or your device falls under a class III classification regulation
What will FDA inform you of in your De Novo request, including each applicable ground for declining the De Novo request?
null
What is the purpose of an AI letter?
If the De Novo request is missing information and/or data necessary to determine whether general controls or general and special controls can provide reasonable assurance of safety and effectiveness
What does reader training help avoid?
incorrect or un-interpretable results
What will resume once you provide a complete response?
review
What is the reason a De Novo request may be declined?
lack of performance data
What is the name of the section that allows a De Novo request to be granted?
section 515 of the FD&C Act
What is the classification of class II devices?
special controls
What is the result of the final order in the Federal Register providing public notice of the decision?
codification of the device’s identification, classification, and applicable requirements in Title 21 of the Code of Federal Regulations
What is the name of the website that we intend to make the summary of our review available on?
CDRH website
What will be redacted to protect any confidential commercial, trade secret, or personal privacy information in accordance with 21 CFR Part 20.?
null
What may the submitter of the declined De Novo request do?
leverage all information in the De Novo request by incorporating it by reference in a new 510(k) submission
What is the FDA's guidance on De Novo Classification Requests?
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals
What is the OMB subject to review?
Paperwork Reduction Act of 1995
What is the name of the FDA Office responsible for this guidance?
Office responsible for this guidance as listed on the title page
What is permissible for an efficient and less burdensome representative case data set?
Enrichment with diseased/abnormal cases
What is the FDA's responsibility to the public regarding information collection?
complete and review the information collection
What is the current expiration date?
0910-0844
What is the minimum amount of FDA calendar days to Grant/ Decline FDA Substantive Review Additional information (AI)?
120 FDA calendar days
When was the document issued?
September 27, 2023
What is the name of the U.S. Department of Health and Human Services Office of Communication, Outreach, and Development (OCOD)?
OCOD
Where can you find the FDA docket number?
5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852
What is the name of the office that provides the Gui00001825?
Office of Communication, Outreach, and Development
What is the name of the document that is used to manage cybersecurity risks?
SPDF
What is the name of the organization that manages the TPLC Security Risk Management?
19 B. Security Architecture
What is the name of the appendix that contains the Security Control Categories and Associated Recommendations?
Appendix 1
What will introduce biases into the study design?
stress testing
What is the name of the document that is used to submit a Security Architecture Flows submission?
Submission Documentation for Security Architecture Flows
What does not establish any rights for any person and is not binding on FDA or the public?
It does not establish any rights for any person and is not binding on FDA or the public
What is the need for robust cybersecurity controls to ensure?
medical device safety and effectiveness
What may lead to patient harm as a result of clinical hazards?
cyber attacks and exploits
What does ensuring device safety and effectiveness include?
adequate device cybersecurity
What is the name of the organization that reviews Regulatory Submissions?
Center for Biologics Evaluation and Research