Devices Flashcards
2 step process for HDE
Get a HUD designation from teh FDA, submit the HDE to the Office of Device Evaluation
-except in an emergency, can only use after FDA approves HDE, then IRB approval
4 Types of Devices
Significant Risk
Non-Significant Risk
Humanitarian Use Device (HUD)
Exempt
Abbreviated IDE requirements for a NSR device
labeling
monitoring
reporting unanticipated adverse device effects
record keeping
Both ISO & FDA regulations
address overseeing the use of an investigational device
Clinical Device Reports
-financial disclosure to sponsor for 1 yearafter the study, keep records for 2 years and submit COI to IRB
-to the sponsor, monitor, & reviewing IRB at least anually (progress report)
-protocol deviations-notify sponsor & IRB w/in 5 working days if it is done for emregency use
-UADE to sponsor & IRB ASAP, but no later than 10 working days
-UPs to the IRB if unexpected, serious, and has implications for the ocnduct of a study
-If withdrawal of IRB aprpoval submit to sponsor within 5 working days
-submit the final report ot the sponsor & IRB within 3 months
Device Classifications: Class 1
lowest risk, safety adherence to general standards
Device classifications: Class 2
moderate risk, genreal standards & other standards for this class
Device classifications: Class 3
high risk or new ot FDA without prior safety info
Emergency Research IDE
IRB agrees that it is a life-threatening situation, available treatments are unproven/unsatifactory
-collection of valid scientific evidence is ncessary
-for in-vitro diagnostic devices- informed consent is waived for leftover human specimens collected for another purpose as long as not identifiable and the individuals caring for are not part of the research
Exceptions from Informed consent for Devices-FDA
- individual has life-threatening condition & met & document
- investigator and another physcian believe it necessitates the use of the test article
- the subject/LAR is unable to communicate consent
- insufficient time to obtain consent from LAR
- no alternative exists with an equal or better chance of saving life
- IRB is informed within 5 working days
Exempt Devices
Does not include invasive sampling procedure, no more than minimal risk, diagnostic devices
-does not introduce energy into the subject
-not used in a diagnostic procedure without confirmation of diagnosis by another medically established product or procedure
-no IDE application
FDA IDE Investigation begin
After the FDA approves the IDE or 30 days have passed since the FDA received & no notice it can’t begin
FDA IDE Submission requirements for significant risk devices
- Sponsor contact info
- report of prior investigations
- summary of complete investigational plan
- description of methods, facilities, & controls used to manufacture, process, pack, store, & install the device
- sample investigator agreement
- certification that all investigators have signed
- contact info for all IRBs
- certification actions take by each IRB regarding the study
- organization contact info
- if device will be sold, amount charged, & explanation of why it is not commercialization
- categorical exclusion/environmental assessment
- copies of device labeling
- forms, info to subject & ICF
- any other relevant info
FDA Office of Orphan Prodcuts Development (OOPD)
-advance evaluation & development of products (device & drug) that demonstrate promise for the diagnosis & treatment of rare diseases/conditions
-HUD within grants HUD designation
-encourages discovery & use of devices in HUD populations
-Provides manufactures with incentive to develop products for small populations when costs exceed returns
GCP Devices ISO (International Organization for Standardization)
ethical design, conduct, recording, & reporting of clinical investigation to assess safety & performance of medical devices
-origin in DOH & Neuremberg
-Device studies outside the US
HDE (Humanitarian Device Exemption) Holder
-the entity that obtains approval from the FDA, could be an individual, firm, sponsor, or manufacturer
HDE Holder Responsbilities
- ensure appropriate labeling
- ensure HUD in facilities with IRB oversight
- monitor # people that use the device support not more than 8,000
- Ensure not used prior to IRB approval
- provide users HUD patient informational packet
- Maintain IRB correspondence
- Retain distribution & shipping records
- Report clinical experience, safety info, to FDA-annual reports
HDE Withdrawal
if the device affects moer than 8,000 people in the U.S. a year or if a comparable device is approved, or if the device is approved
HUD & HIPAA
21st Century Cures Act
Clinical use-ni HIPAA authorization
Investigational Use-requires authorization
-6/7/2017-expanded HDE criteria to 8,00, removed requirement IRB to be local
HUD & ICF
-ICF is not required for research if clinical use, but IRB may require ICF as condition for approval, not FDA required
-Also for an HUD, you must label it as an HUD, that it is specific for a treatment, there is no effectiveness data, and post signs where it is stored to prevent unathorized use
HUD Clinical Use vs. HUD investigational use
Clinical: use according to approved labeling to treat/diagnose
-Investigational: collection of safety & effectiveness
HUD Patient Information Packet-for Clinical Use
-No ICF, so risks, benefits, warnings, precautions, contraindications, procedures, must be in information packet
-CDRH HDE listing has ones that are already available
-If no packet, the FDA says you have to give the patient, known risks, explanation of HDE labeling, there is no comparable device, ancillary procedures, use of HUD, postulated mechanism of action, effectivenss not demonstrated
-inform patients of financial cost
Humanitarian Use Device (HUD) investigational use
clinical investigation designed to collect safety & effectiveness data
-clinical use of a HUD according to it’s approved labeling & indications
-must have an ICF approved by an IRB
-depends on if you are using an already approved HDE indiciation or testing an indication outside the approved HDE
-If wanting to investigate a new indication outside of teh FDA HDE, must meet IDE requirements
Humanitarian Use Devices (HUDs)
- intended to benefit patients in treatment or diagnosis of a disease or condition affecting fewer than 8,00 individuals in the U.S. per year
- request to FDA office of orphan products development, response within 45 days that it is approved, returned, or disapproved
- if approved, submit an HDE (Humanitarian Device exemption)
- no evidence of efficacy, only safety needed, and probably benefits to health that outweighs the risk of injury/illness
- restrictions are placed on profitability & can only be used after IRB approval
- must demonstrate no comparable devices are available
- approved HDE authroizes HUD marketing
- Lable must state HUD & effectivenss has not been demonstrated
IDE
Investigational Device Exemption, means the FDA has approved, then IRB needs to approve study
ISO for GCP & ICH for devices, not FDA
- estimated in accordance with the application of risk mangement to medical devices
- Objective review of data
- Summary in, risk management of hazards, occurences, severity, and harm
Medical Device Categories
Based on risk they pose, sponsor initially suggests, IRB & FDA determine
-SR requires protocol & to report prior investigations
-NSR only a protocol required
Medical Device Reporting (MDR)
-Monitor SAEs
-Whenever HUD may have caused or contributed to a death/serious injury, malfunctuned, & would cause if malfunction reoccured
-serious, life-threatening, permanent impariemnt or damage, needs medical/surgical intervention to preclude impairment/damage
-report to FDA & all IRBs within 10 working days
Non-significant risk device
Determined by the IRB, does not meet SR definitions
Abbreviated IDE content
If IRB disagrees, must submit IDE
-devices study not pose significant risk (ex. contacts, temporary caths)
Off-label Use
FDA is okay with off-label use if IRB is okay with it
Premarket Approval (PMA)
similar to IND route, FDA review of clinical investigation results
-Application for FDA approval, most stringent for devices
-needs valid scientific evidence to provide reasonabl assurance the device is safe and effective for the intended use
Premarket Notification (510k clearance)
Substantially equivalent to device already on market, without clinical trials
- used to get FDA medical device approval
-may naufacture to market immediately
Significant Risk devices is defined as an investigational device that is
-Intended as an implant, presents a potential for serious risk to the health, safety, or welfare of a subject (ex. pacemaker, shunt, sutures)
-purported or represented to be for a use in supporting or sustaning human life & presents a potential risk to the health, safety, or welfare of a subject
-for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairement of human health, and presents a potential for serious risk to health, safety, or welfare of a subject
* must submit IDE
Sponsor Device Reporting
UADE-to FDA & all IRBs within 10 working days
-SR determinations to the FDA,
-5 working days to report withdrawal of IRB approval
Withdrawal of FDA Approval-5 working days to all IRBs & investigators
-Device recall-FDA, all IRBs, return, repair, or dispose of units of device within 30 working days
-Progress reports to all IRBs, & FDA for IDE
-Semi-annual reports for a treament IDE
-Current investigator list to the FDA every 6 months
-DMC to study data at specified intervals
-Final report to FDA within 30 working days of completion or termination of a SR device study, and then follow up report to FDA, IRBs, and investigators within 6 months
-For NSR studies, final report ot IRB within 6 months
UADEs
USADEs
UPs
Unanticipated Adverse Device Effects
Unanticipated Serious Adverse Device Effects
Unanticipated Problems
Withdrawal of HUD IRB approval for Clinical Use
inform HDE holder there is a suspension or withdrawal
-the HDE Holder must notify FDA within 5 working days
