Med Device
How much is the US FDA Fiscal Year 2021 application fee for a new drug application that includes clinical data?
$2,875,842
Which CBER offices currently review biologic product submissions?
-Office of Blood Research and Review -Office of Vaccines Research and Review -Office of Cellular, Tissue and Gene Therapies
Which are FDA reported reasons for failures that have occurred in nasogastric tubes? Select all answers that apply.
-Tube Break -Suction Problem -Migration or Expulsion of Device -Leak / Splash -Device Markings / Labelling Problem
Which statements below are true about the US FDA Quality System Regulation for medical devices? (select all that apply)
-can be found in 21 CFR 820 -similar to ISO 13485:2016 -covers installation requirements
Which statements below are true about the US FDA Quality System Regulation for medical devices?
-can be found in 21 CFR 820 -very similar to ISO 13485:2016 -covers installation requirements
Which item(s) below is(are) requirements under 21 CFR 820.20 Management Responsibility?
-establish a quality policy -appoint a Management Representative -provide adequate resources
Which actions taken by a firm require submission of a 510(k) for a new device (assuming the device does not require a PMA or is not exempt)?
-specification developer introducing the device to the US market -manufacturer of finished device accesories who sells them to end users
A class II non-exempt medical device regulated by CBER requires what type(s) of submission to be submitted to CBER
510(k)
A Type B meeting related to an NDA typically takes place
6 months before your NDA is submitted
According to the GHTF classification scheme the lowest risk device is Class .....
A
Which statement below is true about the US FDA 510(k) process?
Before marketing a device each submitter must receive a 510(k) clearance letter from FDA which finds the device substantially equivalent
What is the FDA product code for Breathing Circuit Bacterial Filter?
CAH
What was the US FDA classification of the device in the case study determined to be?
Class II
Which tragic event provided an impetus to the 1976 Medical Device Ammendments?
Dalkon Shield
FDA completes their initial filing review of an NDA within 60 days. What is the letter called that is issued by FDA after the initial filing review to inform the sponsor of the status of the submission acceptance for further substantive review?
Day 74 letter
Match the phases of investigation under an IND to their description
Designed primarily to evaluate safety (phase 1) confirmatory efficacy studies intended to provide statistical evidence of effectiveness (phase 3) preliminary efficacy studies and some dose ranging (phase 2)
Television Receivers, Hospital x-ray machines, Ultrasonic cleaners and laser welding devices are all examples of
Devices Regulated by CDRH & Radiation Emitting Devices
Which of the following statement(s) are not true about FDA's classification of medical devices?
FDA has published classifications for approximately 2,700 generic types of devices
A 510(k) is submitted only for adding pediatric use to a company's device that was previously cleared for adult use. The fee for this submission for FY2020 assuming you are not eligible for a small business waiver is $12,432
False
A Special 510(k) may be used under any circumstance
False
A traditional 510(k) will be found SE (Substantially Equivalent) or found NSE (Not Substantially Equivalent) within 60 days of receipt by FDA (assuming payment is made before the 510(k) is received)
False
According to FDA design controls the User needs must be verified.
False
According to the US Dept. of Commerce Trade Administration Report there are no countries that completely ban importation of used medical devices
False
As a general rule the QSR applies to component manufacturers?
False
FDA Quality System Regulation part 21 CFR 820.30 allows manufacturers to use prototypes for design validation
False
FDA is allowed to photocopy your internal audit records during an FDA inspection.
False
Having a management review once every calendar year is an acceptable practice as long as the CEO attends the meeting in person.
False
Medical Devices are defined in section 514 of the FD&C act
False
Post-market surveillance/vigilance ensures safety and performance of medical devices prior to placement on the market
False
Prior to granting marketing clearance for a class II device under 510(k) the FDA must complete a preclearance inspection of the manufacturing facility identified in the submission or issue a formal waiver of inspection.
False
The Device Master Record (DMR) contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan
False
The FDA Truthful and Accurate Statement is only required for Traditional and Abbreviated 510(k) submissions since for a Special 510(k) a Declaration of Conformity to Design Controls must be included..
False
The design change provisions in 21 CFR 820.30(i) only apply to medical devices after they are released for sale.
False
Traceability requirements under 21 CFR 820.65 apply to all class II medical devices.
False
Using risk management the absolute safety of medical devices can be guaranteed
False
When measured by a pulse oximeter, SaO2 is termed SpO2.
False
Widget Corporation's Director of Development asks her R&D team to see if it is feasible to design a new ventilator that might be used in rural care areas before seeking project funding from Widget's board. The R&D team needs to follow Design Controls for this feasibility stage of the project.
False
Your company owns two manufacturing sites one in Romania and the other in the US. Each site has their own separate quality system procedures and policies. The US site is launching a new class II pulse oximeter monitor and they use a measurement board that they get from their Romanian manufacturing plant. Since both sites are owned by the same company the US site does not need to apply FDA QSR purchasing controls to the procurement of the board.
False
Which agency names below were not predecessors of the today's US Food and Drug Administration?
Food Drug and Medical Device Bureau & Department of Agriculture Animal Feed and Fertilizer Bureau
Choose the design specifications that may be used to describe a biofilter (choose all that apply)
Resistance to Flow & Bacterial Filtration Test
A 510(k) submission sent to FDA must demonstrate that the new device to be marketed is {FILL IN THE BLANK} to a legally marketed device.
SE
When there is a change or modification to a medical device that is legally marketed in the US under a 510(k) and that change could significantly affect safety or effectiveness then a new 510(k) is required.
True
You are the supervisor for your firms Inspection and Test Dept. The FDA QSR does not allow you to conduct an internal audit under 21 CFR 820.22 of the inspection records for an ECG monitor.
True
Under FDASIA which item(s) below are not required to be in place prior to the start of the detailed FDA review for a 510(k) submission
evidence of device listing for the device type which is the subject of the 510(k)
Which of the following are important design characteristics/aspects for a pulse oximeter sensor? (choose all that apply)
-Biocompatibility of patient contacting materials -wavelengths of the LEDs -spring tension in a reusable sensor
Regulations for the 16 medical specialities corresponding to FDA classified devices can be found in
21 CFR 862-892
The content of what goes into an NDA submission is found in 21 CFR [x]
314.50
The Public Health Services Act section [x] requires a biologic license to exist for a biologic product to enter interstate commerce.
351
The main form for a BLA submission application is Form [x]
356h
The CTD is organized into ___modules. Module 1 is_____specific.
5 region
In your own words please write a short description using complete sentences on how a United States bill or resolution becomes a law. You will be graded on your writing as well as the content so take your time.
A law begins with submitting a bill to Congress; either the House of Representatives or the Senate, who then review it in committee. Once it has been debated over and hasn't already been ruled out, then it moves on to the other House to be voted on. Finally, if it makes it past both Houses of Congress, the President can decide to sign it, making it a law.
Which of the following meet the FDA criteria for a legally marketed device that you can compare to in a 510(k) submission? Select the best answer.
All choices are FDA criteria for a legally marketed device -a device which has been found SE through the 510(k) process -a device which has been reclassified from Class III to Class II -a device that was legally marketed prior to May 28, 1976 for which a PMA is not required
FDA has determined your device is NOT substantially equivalent. Depending on the precise circumstances the following are possible options for the company's next steps to bring the device to the US market Choose the best answer.
All of choices may be options depending on the circumstances -resubmit another 510(k) with new data -request a class I or II designation through the de Novo process -submit a Premarket Approval application
Which are the following are true about prescription drugs?
Healthcare practitioners can prescribe off-label
A Breathing Circuit Bacterial Filter is a class {select} device in USA
II
The international quality systems standard for medical device manufacturers is:
ISO 13485
When did the FDA QSR first become effective for medical devices?
June 1, 1997
What is the correct FDA Product Code for Neyhard's device?
LZG
Prescription drugs are also called [x] drugs
Legend
NDC stands for [x]
National Drug Code
NDA stands for [x]
New Drug Application
Which FDA office has primary responsibility for FDA field inspections of medical devices?
Office of Regulatory Affairs (ORA)
EU Harmonized standards are published in the:
Official Journal of the European Communities
In your own words please write a short description using complete sentences on how a United States law becomes a regulation. You will be graded on your writing as well as the content so take your time.
Once a law is signed into place government agencies are selected to create regulations. Regulations determine how and what a lawful citizen must do to comply with that law. Once a regulation has been written up, it is open to public comments for a short period of time before it is revised and published as Final Rule in the Federal Register. Finally, it is added to the Code of Federal Regulations with all other records of regulations.
Generally speaking what materials are nasogastric tubes made of? Choose all that apply.
PVC with plasticizer & Silicone
Some of the nasogastric tubes we examined in class had a white stripe running the length of the catheter. What is the best answer for why it was part of the design?
Radiopaque that might aid in location of the tube
Match the description of the type of standard to its name
Standard indicating fundamental concepts, principles and requirements with regard to general safety and performance aspects applicable to all kinds or a wide range of products and/or processes (e.g., standards concerning risk management, clinical investigation and the quality management system for the manufacture of medical devices). (basic standard) Standard indicating aspects applicable to families of similar products and/or processes (e.g., standards concerning sterile medical devices, electrically-powered medical devices, stability of IVD reagents). (group standard) Standard indicating necessary safety and performance aspects of specific products and/or processes (e.g., standards for infusion pumps, for anaesthetic machines or for blood glucose meters for self testing). (product standard) Standard deemed to offer the presumption of conformity to specific Essential Principles of Safety and Performance. (recognized standard)
Which of the following (Select all that apply) FDA medical Device databases could be used to search for product problems in Neyhard's device?
TPLC MAUDE
A Levin Style nasogastric tube has only one lumen
True
A Special 510(k) can be used when changes to your device include method(s) to evaluate the change(s) that are well-established, and when the results can be sufficiently reviewed in a summary or risk analysis format
True
All the items below must be considered when insuring your US medical device manufacturing site which makes class III products is compliant with the FDA QSR for Production and Process Controls: environmental control buildings production personnel materials used in manufacturing manufacturing equipment validation of computer controlled manufacturing machines
True
An abbreviated 510(k) must always contain a declaration of conformity to an FDA recognized standard or FDA guidance document
True
As the Quality and Regulatory manager for your medical device firm which sells devices to the US you decide to hire a consultant to help out with the backlog of complaint investigations. Hiring the consultant is subject to FDA QSR purchasing controls.
True
Design Verification shall confirm that the design output results meet the design input requirements
True
Eliminating the causes of potential nonconformities is synonymous with preventative action
True
FDA Establishment Registrations must be submitted electronically
True
FDA's Distribution provisions 21 CFR 820.160 contains a requirement to review purchase orders
True
Financial Certification or Disclosure (FDA form 3454 or 3455) forms are not required if you have not submitted any clinical data in your 510(k)
True
Fred went to an outside training session to become a certified quality auditor. He received a training certificate for passing the course but later lost the certificate before turning it into HR to be placed in his training file. Two months later an FDA inspector auditing the site cites the firm for a violation because Fred is not a trained auditor under "21 CFR 820.25 -Training" after reviewing Fred's training file. The FDA inspector's interpretation is correct in citing this for a violation.
True
Per FDA regulation you must include either a 510(k) summary or a 510(k) statement in every 510(k) submission
True
Prior to the year 1900 selling food, drugs and devices was basically unregulated
True
Standards are increasingly important in medical device regulations. Is the statement "Compliance with most standards is voluntary" true or false?
True
Substantial Equivalence means that the new device is at least as safe and effective as the predicate
True
The FDA definition of a medical device includes in vitro reagents
True
The FDA regulation for Breathing Circuit Bacterial Filter is 21 CFR 868.5260
True
The degree of regulatory scrutiney applied to medical devices by regulatory agencies increases as the risk of the device increases
True
CDRH regulates which of the following products?
all of the above microwave ovens breathing circuit bacterial filters blood pressure monitors
The Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be ______to or _______with an FDA-approved biological product. These new statutory provisions also may be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
biosimilar interchangeable
Choose the single best answer. Lip Gloss with suncreen is considered by the US FDA as:
cosmetic and a drug
In the case study what was Neyhard's latest invention?
insulin infusion pump
Which item below is not a characteristic you would normally use to describe medical devices? (Choose the best single answer)
majority of devices are high risk
Choose the best answer to describe the current trend in regulation of medical devices globally.
number of countries with regulations are increasing and harmonization is increasing
Match the the description and regulatory pathways to the type of drug, biologic or device.
one that is not "generally recognized as safe and effective" or GRASE (New drug) Most (not all) devices in this class use the PMA process (class 3 device) NDA process is used (new drug) Most (not all) devices in this class use the 510(k) process (class 2 devices) BLA process is used (biologic) These drugs GRAS can be marketed without an NDA if they were on the market prior to 25 June 1938 and labeling and formulation are not changed (grandfathered drugs) A drug that no longer has marketing exclusivity as determined by Hatch-Waxman Act (generic drug) Any drug who meets this can proceed to market without additional FDA approval (OTC monograph) Medicinal products derived from or made using living organisms (biologic) ANDA process is used (generic drug)
Match the US regulatory Acts or amendments with the descriptions
passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. (1962 Kefauver) requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. ( Prescription drug user fee) Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation (FDC act 0f 1938) expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective (1984 Drug Price competition) prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs (Pure food and drugs act) defines the kinds of drugs that cannot be safely used without medical supervision that is Prescription versus Over the Counter (OTC)use (1951 Durham-Humphrey)
Match these risk related definitions to the terms
physical injury or damage to the health of people, or damage to property or the environment (harm) potential source of harm (hazard) combination of the probability of occurrence of harm and the severity of that harm (risk) systematic use of available information to identify hazards and to estimate the risk (risk analysis)
Pulse oximetry works based on the principle of detecting the difference between absorption of oxyhemoglobin and dexoxyhemoglobin during pulsatile and non-pulsatile blood flow by using two LEDS and a photodetector. The LEDs operate in which wavelength spectra?
red, infrared
What is the single most important reason why medical devices are regulated by government regulatory authorities?
safety of the patients
An IND applicant is called a [x]
sponsor
The pulse oximeter compares the absorption of light during [answer x] and [answer y] in order to calculate the SpO2
x=pulsaltile flow y=non-pulsatile flow
