BE Device Evaluation Quiz 3
Describe Device Labeling
- Defined in FD&C Act as including all printed matter accompanying any article
When is 510(k) required?
- Introducing a device to the market for the first time - Changing the indications for use of a previously cleared device - Making significant modification(s) to a previously cleared device
What are three ways the FDA continues to monitor device performance after a device has been approved?
- Manufacturer Inspections - Reporting Problems - Active Surveillance
What happens after De Novo is granted?
- New device is legally marketed - New device establishes new classification regulation - Eligible to serve as a predicate for future similar devices - FDA publishes order announcing new classification and controls - FDA generates a public Decision Summary
Describe Establishment Registration
- Owners or operators of medical device businesses intended for use in the U.S. are required to register annually with the FDA
What types of devices fall under each of the 4 main premarket submissions?
- Premarket Notification 510(k): Class II and some Class I devices, most class I and some class II devices are 510(k) exempt - De Novo: New class I or class II devices with a valid predicate - Premarket Approval (PMA): Class III devices - Humanitarian Device Exemption (HDE): Class III device intended to benefit patients with orphan conditions
What are the benefits of interactive review?
- Prevent unnecessary delays - Reduce overall review time - Ensure that FDA's concerns are clearly expressed - Minimize the number of review cycles - Ensure timely responses for submitters
While 510(k) is not required, the following regulatory requirements must be fulfilled for 510(k) exempt Class I and II requirements
- Registration and Listing - Labeling - Good Manufacturing Practices (GMP) - unless the device is specifically exempt from GMP
The device is said to be substantially equivalent to a predicate device if it has:
- The same intended use AND - The same technological characteristics OR differences in technological characteristics do not raise different questions regarding safety and effectiveness - The new device is just as safe as the predicate device
If medical device developers have enough information to demonstrate the device's _______ and __________, an application is filed to ________________________.
- safety and effectiveness - obtain the FDA's approval for marketing of the device
Most Class I and some Class II devices are exempt from 510(k). However, they are not exempt from other general controls, including
-QSR, intended use marketing only, packaging, proper labeling, establishment registration, and device listing - May or may not be exempt from GMP
What are the 5 premarket requirements?
1. Classify your device (Class I, II, or III) 2. Choose the correct Premarket Submission 3. Prepare the appropriate information for your Premarket Submission to the FDA 4. Send your premarket submission to the FDA and interact with the FDA during review 5. Complete the Establishment Registration and Device Listing
What are the 5 steps of the Device Development Process from an FDA perspective?
1. Device discovery process & concept 2. Preclinical research - prototype 3. Pathway to market approval 4. FDA Review 5. FDA Post-Market Safety Monitoring
What are 5 questions to ask when establishing substantial equivalence?
1. Is the predicate device legally marketed? 2. Do the devices have the same intended use? 3. Do the devices have the same technological characteristics? 4. Do the different technological characteristics of the devices raise different questions of safety and effectiveness? 5. a) Are the methods acceptable? b) Does the data demonstrate substantial equivalence?
Explain the De Novo process
1. Medical device sponsor submits de novo request for a new medical device 2. FDA decides whether to re-classify the device from Class III to Class I or Class II with new classification - Sponsor may choose to submit 510(k) first if potential predicate device exists
Not all 510(k)'s require clinical data. Clinical data may be requested in the following situations
1. New or modified indications for use (same intended use) 2. Significant technological differences 3. Non-clinical test methods are limited or inappropriate due to specific indications for use or device technology
Why would someone submit a direct De Novo request? (No prior 510(k) submission)
1. Sponsor believes that there is no suitable predicate device either based on their own assessment or through FDA feedback OR 2. Sponsor believes the device may be classified into Class I or II per De Novo
What is the time frame for review of a De Novo request?
120 FDA days
Approximately ______% of total classified devices are exempt from 510(k)
47% (93% Class I, 9% Class II)
What is a predicate device?
A legally marketed device, previously cleared through the 510(k) process mainly that is used for comparison to a new device for the purpose of determining substantial equivalence
What is 501(k)?
A premarket submission to FDA to demonstrate that the new device is substantially equivalent to a predicate device (i.e. legally marketed in the U.S.) and is not subjected to PMA
What is De Novo?
An application sent by a medical device sponsor to FDA that if granted: - Establishes a new "device type" along with classification, regulation, necessary controls, and product code - The device will be eligible to serve as a predicate for new medical devices, where appropriate - De Novo is also know as "Evaluation of Automatic Class III Designation"
What are the three types of performance testing for 510(k)?
Bench, Animal, or Clinical
What are the pathways to market for each risk Class?
Class I: 501(k) exemption Class II: Premarket Notification 501(k) - some may be exempt Class III: Premarket Approval (PMA)
What devices take the HDE (Humanitarian device exemption) pathway?
Devices for orphan (rare) diseases intended to benefit patients in diagnosis/treatment of disease affecting or manifested in fewer than 8,000 patients per year in the U.S.
What does a De Novo application include?
Evidence that establishes reasonable assurance of safety and effectiveness of the new device - Similar to traditional 510(k) - Must include performance testing data - Must characterize potential risks and way to mitigate those risks - Must include the rationale for why the device does not fit into an existing regulation - If proposing Class II, need to identify special controls to mitigate health risks
Explain the FDA's review of a direct De Novo
FDA may interact with the sponsor (recommended) and ask for additional information. - FDA issues a final De Novo decision: Grant or Decline
Quality systems for FDA -regulated products are known as:
Good Manufacturing Practices (GMP)
What is interactive review?
Informal interactions between FDA and submitters during the preparation of 510(k) and during review.
What type of devices need 501(k) premarket notification?
Most class II and some class I devices
What devices go into the De Novo pathway?
New device that has never been marketed in the U.S. but whose safety profile and technology are reasonably well understood
What types of devices may require De Novo?
New device whose type has not previously been classified (Provides the means to classify as Class I or Class II)
What happens with a NSE (no substantial equivalence) decision?
Resubmit another 510(k) with new data, PMA, de novo or reclassification petition
Describe the 510(k) Submission Timeline
Review slides
Know how to use the 510(k) and De Novo Databases
Review slides
The pathway to approval for a medical device depends on its ___________.
Risk classification
Performance testing must include _____, ________, and _________.
Test methods, acceptance criteria, and test results
Necessary performance tests depend on:
The complexity of the medical device and its intended use and indications
What is the goal of preclinical research and prototype?
To reduce risk of harm in people
Describe the three types of 501(k) submission
Traditional 510(k): - can be used under all circumstances - Relies on the demonstration of substantial equivalence Abbreviated 510(k): - Special criteria must be met - Relies on the use of guidance, special controls, and standards. - Test data may not be needed under special circumstances Special 510(k): - Special criteria must be met - Device modification to manufacturer's own legally marketed device the does NOT affect the intended use of fundamental scientific technology - Data submission are not required by the FDA
When is De Novo classification required?
When no identifiable predicate device whose type has previously been classified exists (allows for classification into Class I or Class II)
GMP's must include _________ and ______, and as much as possible __________________________.
design controls, proper labeling, adherence to international standards
510(k) submission must include
proof of SE (substantial equivalence)
