BIOE5250

Match these standards nomenclature terms to their definitions

May (acceptable alternative) Shall (must) Note (clarification) Should (preferred)

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

In the case study what was Neyhard's latest invention?

insulin infusion pump

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

The FDA relies upon only [fill in the blank] to determine whether there is reasonable assurance that the device is safe and effective.

valid scientific evidence

A PMA applicant must submit manufacturing information during the application process

True

How much is the US FDA Fiscal Year 2021 application fee for a new drug application that includes clinical data?

$2,875,842

The FDA FY2021 Device User Review Fee for a traditional PMA (assuming this is for the company that does not qualify as a small business and does not qualify for any other waivers or exemptions) is closest to which of the following amounts:

$365,000

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

A Significant Risk device means an investigational device that: {choose all correct answers}

-Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; -Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; -Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; -Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject

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 special provision of the law requires the FDA, upon request by the applicant of a PMA, to meet with the applicant to discuss the review status of the application not later than {Fill in the blank}days of the filing

100 days

Under the new 2017/745 Medical Device Regulations General Medical Devices in the EU are regulated by :

2017/745

Non-clinical laboratory studies included in a PMA application (unless justification is provided) must be conducted in compliance with:

21 CFR 58 Good Laboratory Practice for Non-clinical Laboratory Studies

Regulations for the 16 medical specialities corresponding to FDA classified devices can be found in

21 CFR 862-892

When is the date of application of the Medical Device Regulation where enforcement begins of at least all Class I devices in EU?

26 May 2021

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 FDA will perform an initial filing review on a PMA submission to determine whether to file the PMA or not. This initial review is stipulated to be completed within:

45 days

The CTD is organized into ___modules. Module 1 is_____specific.

5 region

A class II non-exempt medical device regulated by CBER requires what type(s) of submission to be submitted to CBER

510(k)

Regulations pertaining to PMA's are found in Section _______of the FD&C Act and in 21 CFR Part ________

515 814

A Type B meeting related to an NDA typically takes place

6 months before your NDA is submitted

Under the Medical Device Directives General Medical devices and Active Implantable Medical Devices are currently regulated by which two different council directives?

93/42/EEC and 90/385/EEC

According to the GHTF classification scheme the lowest risk device is Class .....

A

Match the type of PMA supplement or PMA documentation to the statement.

A change that enhances the safety of the device (special PMA supplement) modifications to manufacturing processes that effect safety and effectiveness but do not involve a change in the manufacturting site location (30 day notice) changes in the device that are significant and impact safety and effectiveness (PMA supplement 180 days) changes that do not affect the safety and effectiveness of the device such as a minor changes to manufacturing procedures like editorial changes to an standard operating procedure to improve the clarity of the instructions (document to file)

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.

Match the name of the Standard Development Organization (SDO) as to whether it is an international or national SDO

ANSI (National) IEC (international) DIN (National) AAMI (National) ISO (international)

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

Detailed EU general medical device classification rules are found in (select the best answer):

Annex IX of MDD/ Annex VIII MDR

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

Match the statement shown to the PMA type

Clinical evaluation and marketing approval merged into one regulatory mechanism (product development protocol) Pilot program in the Division of Clinical Laboratory Devices (streamlined) PMA Shell developed (modular) Complete PMA application submitted to the FDA at one time (traditional)

Company A contracts with Company B to perform the design and manufacturing of a new class IIb medical device. Company B further ships to Company C who performs packaging and labeling under contract for Company A. Company A is the name on the label. Who is considered the legal manufacturer by the EU definition?

Company A

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

Liechtenstein is a member of:

EFTA

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 Summary of Safety and Effectiveness Data (SSED) as mandated by the FD&C act 520(h)(1)(A) and 21 CFR 814.44 provides an objective, and balanced critique of the scientific evidence which served as the basis of the decision to approve or deny the PMA will always be made publicly available 180 days after the FDA filing date for the PMA

False

A non-significant risk device study requires IRB approval as well as an IDE submission and approval by FDA

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

Any manufacturer doing business in the EU must designate an Authorized Representative (AR) and the AR name must appear on the device labeling

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

FDA will send the applicant an approval order if the application substantially meets the requirements of the FD&C Act, and FDA believes that it can approve the application if specific additional information is submitted or specific conditions are agreed to by the applicant

False

Having a management review once every calendar year is an acceptable practice as long as the CEO attends the meeting in person.

False

Language requirements for professional use medical devices are decided by the EC commission

False

MDCG MDR Guidance are legally binding documents that are developed by the EU medical device coordination group through a process of consultation and in general reflect the positions of the CA, NB and industry.

False

Medical Devices are defined in section 514 of the FD&C act

False

Panel reviews are always required for 180 day PMA supplements

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

The sponsor of a significant risk study must only comply with the abbreviated IDE requirements described under 21 CFR 812.2(b)

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

Which are the following are true about prescription drugs?

Healthcare practitioners can prescribe off-label

Match the countries to membership in EU, EFTA or neither EU/EFTA

Hungary (EU) Slovenia (EU) Norway (EFTA) Turkey (neither) Luxembourg (EU) Poland (EU) Iceland (EFTA) Croatia (EU) Serbia (neither) Belarus (neither)

The following are the 4 classes of general medical devices in the EU classification scheme:

I, IIa, IIb, III

What is the international standard used for medical device Software development process?

IEC 62304

A Breathing Circuit Bacterial Filter is a class {select} device in USA

II

Which of the following is not true about IRB's?

IRB's are always affiiliated with a hospital

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.

Which statement below is true concerning an FDA PMA?

PMA's are only required for Class III devices

Generally speaking what materials are nasogastric tubes made of? Choose all that apply.

PVC with plasticizer & Silicone

choose the true statement about FDA performance standards

Performance standards are part of the US medical device regulation and are covered by FD&C Act section 514

The FDA Office of Compliance reviews the Quality System design and manufacturing information in a PMA application to determine if a firm is ready for a:

Pre-approval inspection

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

Choose the design specifications that may be used to describe a biofilter (choose all that apply)

Resistance to Flow & Bacterial Filtration Test

Match the type of Software function/mobile APP to the FDA regulatory approach as outlined in the Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff , Document issued on September 27, 2019

Software functions that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received (NOT) Software functions that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider (FDA intends to exercise) Software functions that acquire or process physiological signals that connect to bedside (or cardiac) monitors for active patient monitoring. (focus of FDA) Software functions that alter the function or settings of an infusion pump (focus of FDA) Software functions that use a sensor or electrode attached to the mobile platform or tools within the mobile platform itself (e.g., microphone and speaker) to electronically amplify and "project sounds associated with the heart, arteries and veins and other internal organs" (focus of FDA) Software functions that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most appropriate to their needs (FDA intends to exercise) Software functions that keep track of medications and provide user-configured reminders for improved medication adherence (FDA intends to exercise) Software functions that are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness (NOT) Software functions that record the clinical conversation a clinician has with a patient and sends it (or a link) to the patient to access after the visit (NOT) Software functions that use a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart (electrocardiograph or ECG). (focus of FDA)

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

A study of a device intended solely for veterinary use is exempt from the FDA IDE regulations.

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 HDE is similar in both form and content to a PMA application, but is exempt from the effectiveness requirements of a PMA

True

An abbreviated 510(k) must always contain a declaration of conformity to an FDA recognized standard or FDA guidance document

True

Are accessories to medical devices regulated under the Medical Device Directive?

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

IDE submission requirements can be found in 21 CFR 812

True

Informed Consent is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study

True

Is compliance to an EU harmonized standard voluntary?

True

Is it possible for a non-CE marked device to be displayed at a Trade show in the EU?

True

Most PMAs for first-of-a-kind devices are taken before the appropriate advisory panel for review and recommendation.

True

PMA requirements apply to Class III preamendment devices, transitional devices, and postamendment devices

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

Revision of existing information in a PMA application or a PMA Supplement is called a PMA Amendment.

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 New Approach to device regulation and the Global Approach to conformity assessment is a legislative technique that includes the definition of mandatory essential requirements, the setting up of appropriate conformity assessment procedures and the introduction of CE marking.

True

The Office of Surveillance and Biometrics (OSB) is responsible for statistical review of marketing applications

True

The degree of regulatory scrutiney applied to medical devices by regulatory agencies increases as the risk of the device increases

True

There is no fee associated with an IDE submission to FDA

True

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

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

All the following can be true about a custom-made medical device in the EU except:

carries the CE mark

Which of the following is required for a company who is testing a new device in an investigational human study?

compliance with design control requirements (21 CFR 820.30)

Choose the single best answer. Lip Gloss with suncreen is considered by the US FDA as:

cosmetic and a drug

According to the MDD, which is not considered "placing on the market" ?

distrubuting a new device for use in an EU clinical trial

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 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