RAC US Exam Question No 18

Question No 18:

A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital for reversible medical consequences as a result of the defective product. What type of recall classification would be assigned to this product.

A. Class I
B. Class II
C. Class III
D. Class IV

Answer: B

RAC US Exam Question No 17

Question No 17:

If a company is planning to market a medical device that is substantially equivalent to a device marketed before 1976. t can use one of the following regulatory paths:

A. IDE
B. PMA
C. 510(k)
D. Special Assessment Protocol

Answer: A

RAC Exam Questions

FDA Ends Voluntary Audit Pilot Ahead of 'Fully Operational' MDSAP

The Food and Drug Administration (FDA) to withdraw said one of his drivers to audit progress in the implementation of a program fee "fully operational" in medical devices Individual control (MDSAP) in 2017.
FDA announced changes in the Federal Register Thursday, saying it "will not accept ISO 13485. 2003 Presentations formless voluntary audit After March 31, 2016 To Help Transition one MDSAP fabless"

ISO 13485: 2003 Pilot Presentation

In 2010, the FDA issued a draft Guidance paragraph describing a pilot program has allowed the companies perform other audits Working Group Global Harmonization Task Force (GHTF) Members meet para Founders Program Requirements Compliance Medical Devices FDA. Guide the term be back soon more years, and the pilot program launched June 5, 2012.
Under the pilot project, the establishments classified as low risk on the basis of the audit reports submitted its eligible to be removed from work routine FDA inspection Year Plan of the United Nations, which could limit the number of audits Spending Establishment of a Dębe.

Pilot MDSAP

However, in October 2012, GHTF s'ha dissolved, and work is beginning on the Regulators Forum International Medical Devices (IMDRF) New Program to Develop, facilitate MDSAP for exchange between audit regulators.
In January 2014, Lanzo IMDRF three-year pilot project, which should be completed a final ProBAR 2016 Feasibility MDSAP para.
The Purpose of MDSAP is for verification of recognized organizations satisfy audits for all the regulators involved in the program requirements, including FDA, Therapeutic Goods Administration of Australia (TGA); National Health Surveillance Agency of Brazil (ANVISA); Health Canada; The Japanese Ministry of Health, Labour and Welfare and the Japan Pharmaceuticals and Medical Devices Agency (PMDA).

MDSAP full in OPERATION

In September, the FDA issued a Mid Controller highlighting the progress made in paragraph Pilot MDSAP July 2015. According to the report the main drivers majority Objectives are Met s'han; However, the pilot had paragraph Problems attract participation from industry. Halfway through the pilot, only 45 production centers had applied to join the Far 330 pilots had expected.

RAC US Exam Question No 16

Question No 16:

Which of the following states is NOT true with respect to both Investigational New Drug (IND) Applications and Inverstigational Decice Exemptions (IEDs) for significant- risk products?

A. The investigational product must be manufactured in full compliance with CGMP
B. Clinical studies must be reviewed and approved by an Institutional Review Board
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless FDA notifies the sponsor otherwise.
D. The application must include and environmental impact statement that contains a claim for categorical exclusion or and environmental assessment

Answer: A

Two More Companies Questioned by FDA Over DTC Genetic Tests

The Food and Drug Administration (FDA) has sent letters to both genetic testing companies marketing directly to consumers pharmacogenetic tests.

Letters to Healthspek and genomics Express, they say the tests that are sold by companies websites meet the definition of a medical device and must be approved by the FDA prior to marketing.

 
In the letters, James Woods, deputy director of the FDA for patient safety and quality of office products Vitro Diagnostics, says companies must either demonstrate that the tests have been deleted, or explain why "do not believe [that] are required to obtain FDA approval. "

Both companies offer pharmacogenetic tests directly to consumers via their websites and test the law Amendments Clinical Laboratory Improvement (CLIA) certified laboratory.

Although the website express genomic said: "Medical requisition necessary," it seems that customers can supplement the output for the three tests specified not apply. On the other hand, just ask Healthspek contact the doctor, even if the information is not necessary to complete the exit.

Reply Healthspek

Randy Farr, CEO and co-founder of Focus Healthspek said his company is preparing its response to the FDA, but the FDA wants to hear "specific reasoning" and looks forward to "discuss these broader issues and" with agency.

"We anticipate a favorable alliance with the FDA as the industry continues to answer health care consumers

Trend Application

Since September, the FDA issuedsimilar other letters to five companies: Pathway Genomics, DNA4Life, DNA-Cardiocheck, Interleukin Genetics and Harmonyx.

Told Focus in September, Pathway Genomics Commercial Director says Ardy Arianpour proof of his company, which aims to detect the DNA of the tumor in undiagnosed patients, is provided in compliance with CLIA and should be treated as an LDT.

The letters come at a time when the FDA grows to increase the monitoring developed laboratory tests (LDT). -

In 2014, the FDA issued draft guidance framework for the regulatory oversight of POW, who proposed similar regulations LDT diagnostic in vitro (IVD), using three classes according to risk.

At a congressional hearing in November, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the Agency's plan, arguing that many tests pose a direct risk to patients when given false results or those that are not validated.

RAC US Exam Question No 15

Question No 15:

FDA currently requires that all medical device registration and listing information (Annual, Initial or Updates) be submitted using?

A. FDAs Unified Registration and Listing System
B. FDA Forms 2891 and 2892
C. FDA Forms 2656 and 2657
D. FDA Form 3356

Answer: A