module 4

After receipt of the PMA, the FDA has ______ days to determine if the application is complete, file it, and notify the applicant. Then, the FDA has ______ days from the date of filing for their PMA review. 45, 90

45, 180

What approval pathway should a sponsor seek if the medical device does not qualify for an HDE (humanitarian device exemption), is high risk based on being a new device, and has a predicate device? Premarket approval (PMA) De novo pathway 510k (also called a premarket notification, PMN)

510k (also called a premarket notification, PMN)

Which of the following studies would NOT be IDE exempt (meaning an IDE is needed)? 1. A modified mouthpiece that is undergoing consumer testing on their preference, and is not putting subjects at risk. 2. An invasive diagnostic test. 3. A study on a legally marketed device used in accordance with the labeling.

An invasive diagnostic test.

True or False: The FDA is can disapprove an IDE if it believes the study design is inadequate to support a future PMA, 510k, humanitarian device exemption (HDE), or de novo classification.

False--his is true based on a revision to the FD&C Act in 2012. See your IDE lecture for details. Disapproval is based on concerns related to subject safety and protections - not study design. The FDA can make recommendations (but not requirements) regarding study design to help study achieve its goal.

Non-significant risk (NSR)

Indicates that a non-exempt IDE has abbreviated requirements

The __________ is/are responsible for maintaining and obtaining appropriate informed consent.

Investigator (not the Sponsor or IRB)---le both the sponsor and investigator need to maintain adequate records, only the investigator is responsible for obtaining appropriate informed consent. Sponsors must gain IRB approval. See IDE lecture and 21 CFR 812 Subpart E for details on investigator responsibilities, including: Conduct investigation per signed agreement, investigational plan, FDA regulations, and conditions of approval Protect rights, safety, and welfare of subjects under care Control of investigational devices-Supervise device use, appropriate disposal Obtain appropriate informed consent

Substantial Equivalence (SE)

Is demonstrated by a successful premarket notification (PMN) when compared to a predicate/already marketed device

Choose which of the following is/are NOT example(s) of Special Controls for medical devices. Guidance Documents Guidance Documents Special Labeling Medical Device Reporting (MDR) Testing

Medical Device Reporting (MDR) MDR is part of General Controls.

510k

Notifies the FDA of a company's intent to market a medical device and requires General & Special Controls

Class I Medical Device

Presents minimal harm and most are exempt from the regulatory process

Premarket Approval (PMA) Is a regulatory submission that provides a means for distributing the devices that have not been cleared for marketing

Requires submission of evidence to establish safety and effectiveness of a high-risk device, whereby substantial equivalence has no basis or was not found

Which of the following is/are a combination product(s)? Metered dose inhalers Condom with spermacide Surgical tray with instruments

all

Which of the following is/are components of the IDE Application (per your IDE lecture and 21 CFR 812.20)? Labeling Investigator agreement Charge for device

all

The following medical support stocking was FDA cleared via a 510k premarket notification in 2010, Shape to Fit Compression Socks. Use the document in the link to answer the following: The compression socks are classified as General Hospital, with guidelines in 21 CFR 870.5780.

false

Recall your viewings/readings, including the Van Norman article. Which of the following is/are FALSE/true An example of a Class II "moderate risk" device is surgical gauze.

false--Surgical gauze is Class I, whereas an example of a Class II provided in your Van Norman, GA (2016) reading is a suture.

Non-exempt studies from IDEs are either significant risk (SR) or non-significant risk (NSR). Which of the following statement(s) about non-exempt device studies is/are FALSE/ true Studies on medical devices with SR can start 15 days after submitting a full IDE.

false--or SR devices, the FDA must approve the IDE before conducting the clinical study

True or False: An emergency use investigation device exemption (IDE) must be for a life-threatening or serious condition, and the emergency use IDE needs FDA approval before use.

false-he emergency IDE does not need FDA approval (approval is post hoc), however, the IDE report should be submitted within 5 days of use. See your reading for more information.

Investigational Device Exemption (IDE)

s a regulatory submission that provides a means for distributing the devices that have not been cleared for marketing

Non-exempt studies from IDEs are either significant risk (SR) or non-significant risk (NSR). Which of the following statement(s) about non-exempt device studies is/are FALSE/ true Devices with NSR use abbreviated IDEs, which do not require submission to the FDA, since IRBs serve as an FDA surrogate.

true

Non-exempt studies from IDEs are either significant risk (SR) or non-significant risk (NSR). Which of the following statement(s) about non-exempt device studies is/are FALSE/true Studies on implants pose significant risks to the health, safety, and welfare of subjects and require full IDEs.

true

Recall your viewings/readings, including the Van Norman article. Which of the following is/are FALSE/ true The three 510k programs are the third-party program, special 510k, and abbreviated 510k.

true

Recall your viewings/readings, including the Van Norman article. Which of the following is/are FALSE/true A PMA is required by the FDA for a new device that has no predicate, unless the device can be reclassified as 'de novo'.

true

The following medical support stocking was FDA cleared via a 510k premarket notification in 2010, Shape to Fit Compression Socks. Use the document in the link to answer the following: Shape to Fit Compression Socks are substantially equivalent (SE) to the predicate device for the indication requested.

true

The following medical support stocking was FDA cleared via a 510k premarket notification in 2010, Shape to Fit Compression Socks. Use the document in the link to answer the following: The General Controls for the product include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

true

True or False: One reason a medical device is different from a drug is that a medical device does not achieve its principal intended purposes by chemical action or by being metabolized.

true--Drugs achieve their intended purposes by chemical action or metabolism. See 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act for more information.