US Flashcards
1
Q
What is a medical device?
A
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including a component part or accessory
2
Q
What milestone did the Safe Medical Devices Act establish in 1990?
A
- Extended adverse event reports to user facilities
- High risk device tracking requirements
- Defined SE
- 510(k) clearance required before marketing
- FDA authority over Combination Products
- Humanitarian Device Exemption
- FDA recall authority
3
Q
The CDRH has the authority to regulate whom?
A
manufacturers, repackagers, relabelers, importers
4
Q
Which device class requires General and Special controls?
A
Class II
5
Q
Which device Class requires General controls?
A
Class I
6
Q
Class II devices require what type of controls?
A
PMA
7
Q
What are the 5 general controls of all device classes?
A
- Establishment Registration 21 CFR 807.20
- Device Listing
- Manufacturing in accordance with 21 CFR 820 GMP regulations
- Device Labeling in accordance with 21 CFR 801 and 809 regulations
- Submission of premarket notification (unless exempt)
8
Q
Special controls contain what extra requirements?
A
- Labeling requirements
- Mandatory performance standards
- Specific Post market surveillance activities
9
Q
21 CFR 814 describes what process
A
PMA of Class III devices
10
Q
A device may be classified as Class III due to what?
A
A lack of information supporting the safety and effectiveness solely through general and special controls
11
Q
Medical devices associated with blood collection and processing procedures, and some IVD if they employ biological technology to achieve their endpoint are subject to which FDA Center?
A
CBER
12
Q
How many device “panels” exist for FDA device classifications?
A
16
13
Q
What is HUD and what is its threshold?
A
Humanitarian Use Device
Affecting fewer than 4,000 individuals in the US
14
Q
What is HDE and what is it exempt from?
A
Humanitarian Device Exemption
Exempt from PMA effectiveness requirements
15
Q
A HUD may only be used under what circumstance?
A
In a facility with an established IRB to supervise the devices clinical use, only after approving the device for that clinical application
16
Q
True or False? Class I and Class II devices are subject to the 510(k) clearance process?
A
True
17
Q
Are all Class I devices exempt from 510(k) clearance?
A
No, roughly 800 have been made exempt
18
Q
How many Class II devices are exempt from 510(k) clearance?
A
Roughly 60
19
Q
Which section of the CFR defines 510(k) submission requirements?
A
21 CFR 807 Subpart E
20
Q
Pre-amendment devices, reclassified Class I & II devices, and devices found to be SE to either of the above devices are all examples of what?
A
A legally marketed predicate device
21
Q
What makes a device SE to a predicate
A
Same intended use and technological characteristics, or same intended use and different technological characteristics that do not raise new questions of safety and effectiveness and the device is at least as safe as the legally marketed device
22
Q
If a device is determined to be NSE, what are the 4 options?
A
- Submit new 510(k)
- Request a Class I or Class II designation through the de novo process
- File a reclassification petition
- Submit a PMA
23
Q
What is MDUFA and what did it implement?
A
Medical Device User Fee Amendments introduced performance goal for the FDA in exchange for User Fees
24
Q
What is the FDA’s MDUFA III performance goal for 510(k) submissions?
A
Decision made within 90 days of active FDA review for >90% of all submissions
25
What are the 3 510(k) pathways?
Traditional, special, abbreviated
26
What is de novo classification?
The risk-based evaluation of automatic Class III Designation
27
What are the 2 options for requesting de novo classification?
- Within 30 days of receiving a NSE for a device not previously classified under the act
- Any sponsor with a device that does not have a predicate or equivalent device
28
What is IDE?
An Investigational Device Exemption
29
What does an IDE allow?
An investigational device to be used in a clinical study to collect safety and performance/effectiveness data to support a PMA or 510(k)
30
What is the least burdensome approach?
The least burdensome approach considers type of info, approaches to obtaining that info, and when during lifecycle that info is reasonably available
31
Do all clinical evaluations of investigational devices require an IDE?
Unless they are exempt, yes
32
How does an IDE differ from an IND?
An IDE requires the sponsor receive written approval within 30 days, whereas an IND may begin a new clinical trial 30 days after receipt with the FDA unless the FDA objects
33
What 5 things are required of devices which have not been cleared for market undergoing clinical evaluation?
- An approved IDE and IRB, if the study involves significant risk
- Informed consent from all patients
- Labeling for investigational use only
- Study monitoring
- Records and reports
34
Is it legal to ship an investigational new device?
Yes, only after it has received an approved IDE
35
What section of the QSR are IDE sponsors still required to follow?
Design Control
36
What is the MDUFMA
Medical Device User Fee and Modernization Act
37
When is an establishment required to be registered with the FDA?
When it is involved in the production and distribution of medical device for commercial distribution (sale or lease)
38
What is an "establishment" when discussing medical devices?
Any place of business under one management at one physical location at which a device is manufactured, assembled, or otherwise processed for commercial distribution
39
Who is the owner/operator?
The corporation, subsidiary, affiliated company, partnership or proprietor directly responsible for the registered establishments activities and who must register the establishment
40
What are FURLS?
The electronic submission of FDA's Unified Registration and Listing System
41
Can an establishment register with the FDA if it has not been approved?
There is no approval of establishment registrations as they only serve to provide the FDA a list of registered products and device categories a manufacturer is operating within
42
What is the OCP and when was it established?
Office of Combination Products; 2002
43
What are the 3 types of combination products?
- drug-device
- drug-biologic
- device-biologic
44
How does a company determine which center is responsible for review of their combination product?
Requesting a formal designation from the FDA using a Request for Designation (RFD)
45
How long does the OCP have to make a determination during an RFD?
60 days
46
What are the means to which the FDA evaluates product safety and risks to US consumers?
Scientific review, standards, manufacturing and other inspections, advertising controls, conditional approvals, laboratory product testing, and postmarket pharmacovigilance
47
What is a "drug"?
A product used in the diagnosing, curing, mitigating, treating, or preventing a disease or affecting the structure or function of the body
48
What is a "biologic"?
A substance derived from or made with the the aid of living organisms or made of large macromolecules found in the body
49
Good Clinical Practices (GCP) is designed for what purpose?
GCP is an internationally accepted, scientific and ethical quality standard to ensure the design, conduct, performance, auditing, recordkeeping, analysis, and reporting of clinical trials involving human subjects
50
When a GCP compliance issue presents itself that has not been addressed by local GCP regulations and guidelines, what should you do?
RA professionals should consult internal and external resources, including their companies QA/RA departments, and/or local Ethics Committees (EC) or Institutional Review Boards (IRB)
51
Which clinical studies are subject to the ICH?
Drugs and biologics
52
What standards are medical devices subject to in regards to clinical trials?
ISO 14155:2011
53
GCPs of medical devices are unique from drugs and biologics in what major way?
They address component issuance, device malfunction, and use error documentation
54
Can a Class III device be approved through the 510(k) process?
Yes, but only certain class III device given that specific designation
55
What happens in the Preclinical phase of a clinical trial?
Testing is conducted on animals to determine toxicology, efficacy, and pharmacokinetic information
56
Which phase of a drug or biologic clinical trial evaluates the metabolism and pharmacological action?
Phase 1
57
Which phase of a drug or biologic clinical trial determines the safe dosage range and identifies side effects?
Phase 1
58
When is it okay to use real patients in a Phase 1 Clinical Trial study?
When the treatment may make healthy patients ill
59
What are the two potential sub-phases of a Phase 2 Clinical Trial study?
- Phase 2a: dosing requirements
| - Phase 2b: efficacy evaluated
60
Which phase of a drug or biologic clinical trial is dosing given at therapeutic levels?
Phase 2
61
Which phase of a drug or biologic clinical trial compares the drug or biologic to commonly used treatments?
Phase 3
62
Which phase of a drug or biologic clinical trial confirms effectiveness?
Phase 3
63
What is the purpose of a Phase 3b study?
To allow a manufacturer to begin the marketing application while continuing to gather information on the drug or biologic and allows patients to continue to receive beneficial treatment until commercial availability
64
Which phase of a drug or biologic clinical trial evaluates postmarket activities and long term effects?
Phase 4
65
How many and what are the phases of a drug or biologic clinical trial?
5: Preclinical and Phase 1-4
66
Will the FDA accept a foreign clinical trial of a medical device?
Yes, if the clinical trial adhered to the Declarations of Helsinki ethical principles or the local governments own laws and regulations if they exceed those established in the Declaration of Helsinki
67
In addition to ISO 14155, what must US manufacturers conducting a clinical trial on a medical device must comply with?
All applicable sections of 21 CFR (Part 11, 50, 54, 486, 812)
68
Can a 510(k) require a clinical trial?
Yes
69
Do all PMA applications require clinical trials?
Yes
70
Which 2 section of the CDRH review premarket notifications (510(k))?
- Office of Device Evaluation (ODE)
| - Office of In Vitro Diagnostics and Radiological Health (OIR)
71
What does Discovery and Concept phase of a medical device clinical trial entail?
Proof of concept and design and development (V&V)
72
When are preclinical trials and bench testing sufficient for establishing SE for a medical device?
When the device is an iterative improvement to technology already commercialized
73
What do Early Feasibility Studies focus on?
Prototype development
74
What phase of the medical device clinicl trial includes First-in-Human (FIH) studies?
Early Feasibility
75
What is the definition of an Early Feasibility study?
A limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication
76
Are Early Feasibility studies required?
No
77
What is the purpose of a Feasibility study?
To gain preliminary safety and effectiveness information and data on a finished or nearly finished medical device
78
What is the purpose of a Pivotal study?
To gain definitive safety and effectiveness evidence for a device within its specific intended use
79
When is a Pivotal study required?
Any time a clinical trial of a medical device is required
80
How many days does an IRB have to report a disagreement with the FDA on the nonsignificant risk determination of a medical device clinical trial?
5 days
81
In terms of ISO GCP, what is the difference between "protocol" and "clinical investigation plan (CIP"?
There is no difference
82
Is IRB approval required for changes to a clinical study prior to implementation at the testing cite?
Yes
83
How does the US GCP and ISO GCP differ in terms of clinical trial deviations?
The US GCP requires notice within 5 days of an emergency deviation
84
Informed consent is required under what circumstances?
Any clinical trial
85
How long does an investigator have to report an unanticipated adverse device effect (UADE) to the IRB and sponsor?
10 days
86
How long does the sponsor have to evaluate the UADE and report their findings to the FDA, IRB, and investigators?
10 days
87
What is a device deficiency?
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety and performance.
88
Do device deficiencies need to be reported to the sponsor when there is no adverse event?
Yes, if it could have led to an adverse event
89
How can a device deficiency be classified?
use error, malfunction, or inadequate labeling
90
Which CDRH division is responsible for the development and execution of inspections as well as the review and classification of resultant establishment registration reports for IDE, PMA, PDP, HDE, 510(k), and IRBs?
Division of Bioresearch Monitoring (DBM or BIMO)
91
Title 21 CR 820 provides detailed requirements for medical devices manufactured under what?
cGMP, also known as QSR
92
What is the QbD approach?
Quality by Design, meaning a products quality cannot be ensured by testing alone
93
What does cGMP require to be established?
A Quality Management System (QMS)
94
What are the 4 Quality System Documentation elements and what is their process flow?
1. Quality Manual
2. Policies and SOP
3. Work Instructions and Process Documents
4. Quality System Records
95
What does it mean for a document to be controlled?
It must be reviewed, approved, and contain a revision history prior to implementation
96
What is the purpose of change control?
To formally document and review any changes made to a product, including manufacturing, raw material, inspection criteria, etc. prior to implementation
97
Where must design control activities be recorded?
Design History File
98
What is the core responsibility of the design and development plan?
To specify the development process, compliance with design control, and assignment of responsibilities for each activity
99
Device requirements encompassing the end users wants and needs, regulatory requirements, patient preference data or postmarket information of similar devices all examples of what?
Design Inputs
100
What are some examples of specific design inputs?
- Specific performance characteristics
- Device specifications
- Reliability requirements
- Clinical constraints (sterility, etc.)
- Handling and Storage
101
Can design inputs include emerging medical needs or physician requests?
Yes
102
What are design outputs?
The manifestation of design inputs; the device characteristics that ensure the device meets all requirements established in the design inputs
103
The design specifications of a device such as size, shape, color, weight, etc. are all examples of what?
Design outputs
104
Is it possible for a design output to not be measurable by verification or validation activities?
No
105
Is software code subject to design inputs and outputs requirement?
Yes
106
What are the 3 most typical ways a manufacturer can conduct design V&V activities?
Bench, animal, and clinical studies
107
What is the difference between verification and validation?
Verification is the process of determining whether or not the design outputs match the design inputs for detailed requirements, whereas validation determines whether the device meets its intended use and functions.
108
When a manufacturer determines whether the right product was manufactured and meets the end-users requirements is an example of what design process?
Validation
109
When a manufacturer ensures a product has been made correctly and meets design specifications, this is an example of what design process?
Verification
110
What is the process of Design Transfer?
When design specifications are finalized and transferred to manufacturing
111
Where is Design Transfer documented?
Device Master Record
112
What form of documentation is required to provide specific detail of the design transfer, ensuring all information is accurately transitioned from the development team to manufacturing?
SOPs
113
When does Design Transfer take place?
Design transfer can take place any time during the design and development phase for finished components of a medical device
114
Can a Design Change happen prior to product launch?
Yes
115
What is the purpose of Design Review?
To evaluate the current state of the design and development of the product to allow for design changes to be initiated and to ensure the product is meeting all end-user needs
116
Where are Design Reviews documented?
Design History File
117
Where should a company implement in-process inspections?
Anywhere a critical manufacturing step has been identified
118
Where are production, labeling, packaging, and other product realization activities documented?
Device Master Record
119
What is IQ-OQ-PQ and what is its primary function?
- Installation Qualification
- Operational Qualification
- Process Qualification
To confirm instrumentation and equipment has been correctly installed, inspected, calibrated, and validated
120
Define IQ
Instillation qualification is qualifying and calibrating a piece of equipment for the manufacturing of a product
121
Define OQ
Operational qualification is verification of the equipment to perform its intended functions
122
Define PQ
Process qualification is validation of of the manufacturing processes related to equipment performance
123
Does equipment software require validation?
Yes
124
Where must equipment and process tolerances be kept?
Somewhere accessible to the equipment operator
125
What is the purpose of establishing acceptance activity procedures for product manufacturing?
To control and document the receiving of in process and final product inspections, including testing, inspection activities, of other means of establishing the product meets specifications
126
All activities relating to the production, testing, and inspection of product should be recorded where?
Device History Record
127
When is a product considered nonconforming in regards to product manufacturing?
When a product is not meeting specifications
128
Where must nonconforming product handling and disposition be recorded?
Device History Record
129
The FDA requires manufacturers to develop handling procedures for nonconforming products which entails what?
- Identifying nonconforming products
- Designating quarantine space
- Review processes for nonconforming products
- Investigation, when applicable, of root cause and initiation of corrective actions
130
Is a label a controlled document?
Yes
131
Is UDI required on all labels?
Yes, when discussing the primary packaging label
132
What is CAPA?
Corrective and Preventive Action
133
When is a Corrective Action taken?
To address a nonconformity that has occurred in order to prevent the failure from occurring again
134
What is a Preventive Action?
The implementation of a process to address a trend or potential issue in order to prevent the failure from occurring
135
When does a Corrective or Preventive Action require V&V?
Always
136
Does every CAPA have to be reviewed in Management Review?
Yes
137
Does every complaint require investigation according to 21 CFR 803?
No, but each complaint must be evaluated to determine if an investigation is necessary
138
What must be documented in the complaint file if an investigation is deemed not necessary?
The rationale behind the decision and the responsible party
139
Does the manufacturer's device need to be included in the occurrence of an adverse event to determine the complaints reportability to the FDA?
Yes
140
How long must quality system documents be maintained according to the QSR?
At a minimum, for the duration of the products expected life, but no less than 2 yrs
141
What documents make up the QSR?
All QMS documentation not specific to a device (eg. quality policy, quality system procedure, etc.)
142
What are the 3 device-specific document assemblies required by the FDA?
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
143
Which document assembly contains a device design and development process?
DHF
144
The DHF is designed to demonstrate accordance with what 2 design aspects?
- Design plan
| - Product specifications
145
What are the minimum documents included in the DHF?
- Design plan and iterations
- Inputs, outputs, product specifications
- V&V testing protocols/reports
- Design transfer records
- Design change information
- Design review minutes
146
Is it expected for manufacturers to have DHF for device developed prior to the QSR being implemented in 1997?
Yes, manufacturers are obligated to develop a DHF to the best of their abilities for every medical device subject to the regulation
147
Which document assembly contains the device "recipe", all information necessary to manufacture a particular device?
DMR
148
At what phase is the DMR created?
Design Transfer
149
What are the main components contained within a DMR?
- Manufacturing instructions
- Testing
- Inspection
- Labeling
150
Is the DMR a complete record containing all related revisions?
No, the DMR should only contain the most up to date revisions of all procedures, work instructions, drawings, inspection and acceptance criteria, tolerances, equipment controls/settings, and any other methods or proceeds related to the manufacturing of the device
151
When is the DMR updated?
Any time changes to the device are made
152
Which document assembly is known as the lot or batch record, containing a specific device or device lot production history?
DHR
153
What is considered the de facto standard for global compliance for cGMP requirements?
ISO 13485
154
Medical devices marketed in the US are subject to which sections of 21 CFR?
1-58, 800-1299
155
What is an in vitro diagnostic?
Reagents, instruments, and systems intended for use in the diagnosis of diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae
156
What are combination products?
Therapeutic and diagnostic products that combine drugs, devices, an/or biological products
157
What is a companion diagnostic?
A medical device, often times an in vitro diagnostic, that provides information essential to the safety and effectiveness of a corresponding drug or biologic, helping the healthcare provider determine risk-benefit for a given treatment
158
What is a mobile medical application?
Any application meeting the definition of a medical device and is an accessory to a regulated medical device or transforms a mobile device into a regulated medical device
159
When is an accessory considered a medical device?
When it can be used with multiple parent devices or has a standalone feature meeting the definition of a medical device
160
Which section of 21 CFR covers Medical Device Classification?
Section 860
161
What is the definition of a medical device classification?
A grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness
162
What are the 2 ways a device can be classified in the US?
- Regulation
| - Product code
163
Are product codes more or less specific than classification regulation?
More specific
164
Can a device be assigned a product code before being classified?
Yes
165
Do the CDRH and CBER use the same 4 letter system for assigning product code designation?
No, both the CDRH and CBER use a 3 letter system
166
What are risk levels based on?
The control level required to assure safety and effectiveness
167
What types of things are taken into consideration when discussing the risk level of a device?
patient population, end user, conditions of use, benefit of use vs probable risks, and reliability
168
How can a novel device be reclassified from Class III to Class II or I?
Through a de novo request
169
Are special controls usually classification specific?
No, special controls are usually device specific
170
Does a new intended use for a medical device automatically categorize it as a Class III?
Yes, but only if SE cannot be established
171
What is a combination device's PMOA?
Primary Mode of Action - the single mode of action to which combination product provides it most important therapeutic action
172
Prior to the de novo process, how id device manufacturers classify low to moderate risk devices to which no predicate existed?
Submission of a 510(k) and subsequent NSE which then allowed the FDA to reclassify the device
173
Can a de novo device be used as a predicate for future regulatory submissions?
Yes
174
What process does the FDA recommend using prior to submitting a de novo request?
A presubmission
175
What is a pre-amendment device?
A device marketed in the US prior to MAy 28, 1976 to which no substantial changes have been made and to which the FDA has not issued a regulation requiring a PMA
176
Do abbreviated IDEs require FDA approval?
No
177
Who must agree with a sponsor's determination of NSR?
An IRB
178
What is a significant risk device?
- Implants; serious risk
- Purported as or for use as a life supporting, sustaining device; serious risk
- Substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health; serious risk
- Otherwise potential for serious risk
179
Why are 510(k) devices cleared, not approved?
Because substantial equivalence is not a determination of safety and effectiveness, only that the device is as safe and effective as a device legally marketed
180
When is a device manufacturer not required to file for a 510(k)?
When the manufacturer functions as a contract manufacturer creating a device to another companies specifications
181
Are accessories to a medical device that are sold to end users considered finished medical devices requiring a 510(k)?
Yes
182
Is there any instance where the specifications developer is not required to a file a 510(k)?
No
183
When must a re-packager or re-labeler submit a 510(k)?
When they significantly alter the devices label or otherwise affect any device condition (ex. sterilization)
184
Do foreign manufacturers or exporters introducing a device to the US market need to submit a 510(k) even if they are not the specifications owner?
Yes, to the eyes of the FDA they are the technical "specifications owner" if they are the first to introduce that specific device to the US market
185
Where in a 510(k) submission should a sponsor include information relating to the clinical settings, target population, anatomical sites, configuration, and other information critical to the intent of use of the device?
Within the Indications for Use statement
186
What process can a device manufacturer to make a 510(k) publicly available?
A FOIA request, however, the sponsor of that 510(k) will be able to redact "trade secrets" making much of the 510(k) unavailable
187
When does the FDA conduct a preclearance facility inspection for 510(k)s?
Facility inspections are not required for 510(k)s, but the FDA may chose to audit a manufacturer of a 510(k) cleared and marketed medical device at any time
188
In a Traditional 510(k), when can a sponsor forgo submission of performance testing data?
When the subject device is identical to the predicate device
189
When is a Special 510(k) used?
When a sponsor is making modifications to its own 510(k) cleared device and utilizes the QSR design controls
190
If a device modification does not change its intended use or alter its fundamental scientific technology, what information can the sponsor instead provide through a Special 510(k) to serve as the basis for clearing the device?
Summary information resulting from the design control process and required 510(k) elements
191
Is a change from OTC to Rx Only or vice versa not considered a change to the devices intended use and therefor eligible for a Special 510(k)?
No
192
Changes to a device's energy type, environmental conditions, performance specifications, user interface, dimensions, software, firmware, packaging, expiration, and sterilization are all examples of device modifications that may be appropriate for which type of 510(k)?
Special 510(k)
193
Are device manufacturers required to submit a complete declaration of conformity to design controls for a Special 510(k)?
Yes
194
When should a device manufacturer consider utilizing an Abbreviated 510(k)?
When FDA guidance and (FDA recognized consensus standards) special controls are adequate to establish SE
195
With an Abbreviated 510(k), is a submitter required to include test data?
Only if the test data is relating to an appropriate and acceptable Declaration of Conformity to an FDA-recognized consensus standard
196
What does a sponsor provide in an Abbreviated 510(k) in lieu of test data?
Summary reports on the use of guidance documents, special controls, and/or Declarations of Conformity
197
Can a submitter utilize an Abbreviated 510(k) with a non FDA-recognized consensus standard?
Yes, but they must get prior approval from the agency prior to submitting
198
How many days does the FDA have to make a RTA designation?
15 days
199
What is the purpose of the RTA process?
To expedite the 510(k) review process by only reviewing complete 510(k)s
200
How many days does a sponsor have to respond to an RTA?
180 days
201
Why was the Accredited Persons Program established?
To allow for accredited persons, either company or individual, to perform 510(k) reviews for certain Class II devices.
202
Are all changes made to a medical device required to be documented?
Yes, within the DMR
203
If a device has gone through several minor changes which only required change control documentation, does a 510(k) need to be filed?
No, but only after an evaluation of the cumulative changes has been made and determined they do not equate to a significant change overall
204
What are the 4 guiding questions the FDA has provided on determining when to submit a 510(k) for a change to a device?
1. Is the change made with the intent to significantly improve safety or effectiveness?
2. Is the change a labeling change?
3. Is the change a technology, engineering, or performance change?
4. Is the change a material change?
205
What are the 3 ways to gain market approval for Class III devices?
- Traditional PMA
- Modular PMA
- Product Development Protocol (PDP)
206
Does the FDA have a process similar to a 510(k) RTA for PMA submissions?
Yes, but it is a 2 step process: Acceptance review and Filing review, where Acceptance review allows 15 days for the FDA to determine the submissions completeness and Filing review which determines basic adequacy of the submission
207
Which concurrent PMA review processes begin once a submission has been filed?
- QSR/manufacturing review
| - In-depth scientific review
208
When should a submitter expect to receive a substantive interactive communication within?
90 days
209
What are the 3 outcomes of a PMA submission?
- Approval; safe and effective for its intended use
- Not approvable; major issues requiring submission of PMA Amendments and further review cycles
- Denial; not safe and effective for its intended use
210
Is the content and requirements for a Modular PMA different from those of a Traditional PMA?
No, the Modular PMA approach just allows the FDA to review portions of the PMA in sections, rather then at one time
211
What is the purpose of a Determination Meeting?
For the sponsor to discuss with the FDA the valid types of scientific data and evidence to demonstrate a device is effective for its intended use
212
How long does the FDA have to provide a decision as to a Determination Meeting outcome?
30 days
213
What is the purpose of an Agreement Meeting?
Formal meeting with FDA to reach agreement regarding an investigational plan review
214
What are the 2 stages of the Parallel Review?
1. FDA and CMS meet with the manufacturer to provide feedback regarding the the proposed pivotal trial within the CDRH Pre-sub program
2. FDA and CMS concurrently review the clinical trial results in the PMA/de novo
215
How often must establishment registrations be updated?
Annually
216
How many days does a facility or establishment have after beginning activities to register with the FDA?
30 days
217
Does registration information have to be submitted if no changes have been made?
Yes
218
What is the definition of a finished device?
Any device or accessory to a device that is suitable for use or capable of functioning, regardless of packaging, labeling, or sterilization
219
When does the FDA communicate the need for a Post Approval Study (PAS)?
At the time of PMA, HDE approval or PDP application
220
What is an ISAO?
Information Sharing Analysis Organization; cybersecurity information sharing focal points among different private sectors and government stakeholders
221
What does the FDA consider to be a critical component of a comprehensive and proactive approach to postmarket cybersecurity management?
Participation within an ISAO
222
How long does a company have to report a death or serious injury to the FDA?
10 days
223
What does it mean if a device has "caused or contributed?"
Death or serious injury was or may have been associated with the use of the device
224
How long does a company have to report an event after they have "become aware?"
30 days, unless death or serious injury has occured
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What is required of a Device User Facility that has submitted an MDR within the previous calendar year?
They are required to submit an annual summary report by January 1st.
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How long does an importer have to report an event after they have "become aware" of a death or serious injury?
30 days, to both the FDA and the manufacturer
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How long does a manufacturer have to report an event after they have "become aware" of a death or serious injury?
30 days
228
When is a 522 Posrmarket Surveillance Study initiated?
- When a device failure would be reasonably likely to have serious health consequences
- The device is expected to have significant pediatric use
- The device is intended to be implanted in the body longer than 1 year
- The device is intended to be life-sustaining/supporting and used outside of the device user facility
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What is it called when the FDA considers a device to be in violation of the laws it administers and subject to legal action/seizure and the company removes the product from the market?
Recall
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Repair, modification, adjustment, labeling, destruction or inspection of a product without its physical removal to another location is known as what?
Correction
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Repair, modification, adjustment, labeling, destruction or inspection of a product after it has been physically removed from its point of use is known as what?
Removal
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Do market withdrawals, routine servicing, and stock recovery correct the violations or reduce the risk the device imposes on public health?
No
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What is the correction or removal of a device which has only been involved in a minor FDA violation?
Market withdrawal
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What is regularly scheduled maintenance of a device?
Routine servicing
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What is correction or removal of a product that has not left a companies direct control?
Stock recovery
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What are the 3 classes of recalls?
- Class I: serious injury/death
- Class II: temporary or medically reversible consequences, or the chance of serious injury or death is possible but remote
- Class III: not likely to have adverse health consequences
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Does a manufacturer have to report a voluntary recall if the device is thought to be in violation?
No
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If the FDA reviews a removal or correction and determines the device to have been in violation, what happens next?
The removal or correction is classified a recall and the manufacturer must go through all applicable recall steps
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What are the main elements of a recall strategy?
- Recall depth
- Public warning required?
- Level of effectiveness checks
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What are the level of effectiveness checks?
- Level A: 100% consignee notification
- Level B: between 10-100% consignee notification
- Level C: 10% consignee notification
- Level D: 2% consignee notification
- Level E: no effectiveness checks required
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What is the intended use of an IVD?
Collecting, preparing, and examining specimens taken from the human body
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What are the 5 IVD types?
- In vitro diagnostic (IVD)
- Research Use Only (RUO)
- Investigational Use Only (IUO)
- General Purpose Reagent (GPR)
- Analyte Specific Reagent (ASR)
243
A pH buffer is an example of what type of IVD?
GPR
244
Do GPR require premarket notification?
No, they are Class 1 exempt
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What is the action to which an ASR IVD functions?
Through specific binding or chemical reaction, are intended to identify or quantify and individual chemical substance or ligand in biological specimen
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When is a ASR a Class II?
When used for specific bloodbanking activities or when they are used as part of a Class II test for screening of contagious fatal disease or blood donor screening
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How does the CDRH determine an IVD complexity categorization?
Through the scorecard method. Scores are given 1-3 to 7 criteria; 1 being the lowest complexity and 3 the highest. The 7 criteria are: knowledge, training/experience, reagent/material preparation, operational steps, calibration and quality control, troubleshooting and maintenance, interpretation and judgement. Scores below 12 are moderate complexity; scores above 12 are high complexity
