RAC US Exam Question No 13

Question No 13:

A manufacturing process requires purified water to produce several finished Class I exempt and Class II 510(k) medical devices. The water is tested monthly by quality control (QC). Since results have consistently been within specifications, the product is sent to distributors before QC results are final. Over the past six months quality test results have been getting closer to the specification limit. Internal review determined that QC testing should now take place weekly. This information should be provided to FDA through:

A. A post approval study report
B. A medical device report
C. This information does not need to be submitted
D. An Annual Report

Answer: C

PIC/S Elects New Chairman, Adds Croatia’s HALMED as Participating Authority

The Plan of Pharmaceutical Inspection Cooperation (PIC / S) elected Paul Hargreaves Regulatory Agency of medicines and products for healthcare in the UK (MHRA) as its new president in 2016 and 2017.

Hargreaves, voted at a meeting in Indonesia last month, will be the fourth PIC / S Chairman of the UK and will continue the march of Joey Gouws, chief of the Board of Control of Drugs in South Africa, which was the first PIC / S acting president for Africa.

After the successful implementation of the new structure of PIC / S subcommittee in 2014, incumbents were also elected for the next seven subcommittees: Training (SCT); Circles of experts (of SCEC) Strategic Development Community (SADC); Compliance (CSC); GM (D) P Harmonization (SCH); Budget, Risk and Audit (SCB) and communication (COM SC).

All continents are represented by the 52 newly appointed charge holders, and 29 are non-European authorities PIC / S participants.

Croatia

In addition to the new president, PIC / S invited the Agency for Medicines and Health Products in Croatia (HALMED) to join the scheme from 1 January 2016. HALMED become the 48th participating authority PIC / S and previously applied for Agency accession on 5 September 2014.

The driver has been accepted in after an assessment of the paper, followed by a site visit from June 29 to July 3, 2015 program was conducted.

Six other regulators have applied for PIC / S, including ANVISA Brazil, Iranian Ministry of Health (in the site visit in September), the COFEPRIS Mexico (site visit scheduled for 2016), FDA Thailand, Philippines PFDA TMMDA and Turkey.

Also, an update on the future potential applicants was given at the October meeting, especially in trade with Food and Drug Administration of China in their interest to ask the PIC / S in the near future.

HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers

The Department of Health and Human Services (DHHS) Friday invitation Pharmaceutical Forum was more of a listening session for a wide range of stakeholders to explain the concerns and discuss a number of possible ways to reduce drug prices, including some Food and Drug Administration (FDA) reforms involved.
HHS Secretary Sylvia Burwell began pointing event the steep increases in drug costs, particularly for specialized medicines, which accounted for approximately $ 87 billion in 2012, or about 25% of total expenditure on drugs US States and could quadruple by 2020.

But the complex problem of ensuring companies remain innovative while providing access to affordable medicines is what motivates the discussion.

"As we work to find the right balance between promoting innovation and keep them accessible and affordable medicines, we must let the principle of putting the consumer at the center of the guide our thinking," Burwell said.

FDA Action

 

Although Burwell disregard the progression of the Senate version of the Act Cures the 21st century, which could include significant changes to the FDA, he said the FDA is looking at ways to accelerate accelerated system of drug development and improve the process examination.

Focusnoted And earlier this week, much of the discussion about the price of drugs and the FDA continues to focus on faster approval of generic drugs and the beginning of a robust market for biosimilars.
Both Steve Miller, MD, Senior Vice President and Chief Medical Officer of Express Scripts and Chip Davis, president and CEO of the Generic Pharmaceutical Association, criticized the FDA for approval of slow rate abbreviated new drug applications (ANDA) and a large portfolio order.

Similarly, Doug Long, vice president, IMS Health said the delay ANDA "is higher than it has ever been" and the FDA has "yet to take a slap at her."

Long also mentions the prospect of biosimilars drop drug bill United States, but said the price is not going to become really competitive as several companies have marketed biosimilars for the same reference product, which probably will not go through a couple of years.

On the subject of the second round of negotiations to user fees for generic drugs (GDUFA), Davis also noted that so far, he felt like a "workspace" if he said he remains optimistic.

Value

 

The question of the actual value of the world of drugs has emerged several times during the forum, and this is an issue that seems to be rampant not only in the US (As the New England Journal of Medicine reported), but other countries and especially with the new anticancer drugs.

Merck CEO Ken Frazier said one face of the challenges that the industry is limited by the tools they can use to talk about certain advantages in the world or the real risks that are not included on the label of a drug.
"Sometimes, in order to have a good idea of ​​what the benefits / risks, we must look beyond the label, but we are limited by FDA regulations," Frazier said.

Similarly, Mark McClellan of the Brookings Institution has called for political reforms that promote the development of valuable treatments and discourage high prices that do not reflect the value and could lead to excessive and unnecessary expenses.

And although the forum has launched a, the strongest national conversation about drug prices and potential pricing based on the value or result-oriented and purchase - what is clear is how HHS plans to take measures and where it could begin.

"This is a complex issue and there is no single solution," Meena Seshamani, Director, Office of Health Reform at HHS, said after the forum.

RAC US Exam Question No 12

Question No 12:

Devices that are exempt from premarket notification are?

A. All Class I devices
B. Some Class I devices
C. Some Class I devices and some Class II devices
D. All Class I devices and some Class II devices

Answer: C

RAC Exam Questions Video

FDA Lays Out New Areas of Interest for Training Device Review Staff

FDA Lays Out New Areas of Interest for Training Device Review Staff:

(FDA) Center for Food and Drug Administration for Devices and Radiological Health (CDRH) on guests from industry, universities and health care to participate again in a program that helps train device personal opinion doctor .
Training Program (PEL) General 2015 Program Experiential Learning, which was first launched in September 2011, aims to provide staff CDRH a better understanding of the policies, practices and challenges of development cycle living laboratory apparatus.

"These visits formal training are not intended for the FDA to inspect, evaluate, judge, or performing a regulatory function (for example, inspection of compliance), but rather an opportunity to provide the review staff CDRH a better understanding of the products we reviewed, "the agency said in a Federal Register notice. "With this opinion, CDRH formally requests the participation of companies, universities and medical centers, including those who have already participated in other business programs the FDA or PEL available."
The program, which was officially launched in April 2013 and then extended and extended again a year later to include 34 new fields of interest, much of which has been associated with in vitro diagnostic technology and manufacturing.

New areas of interest:

Now the Office of Device Evaluation Review wants his staff to focus on eight new themes, including: Device Evaluation Office - new areas of interest

• A proof of biocompatibility
  Decision-making process for evaluating and selecting the biocompatibility test (if necessary); considerations for the use of animal testing in vitro tests against; Sample preparation at the nanoscale, bioabsorbable, and the in situ polymerized materials; color additives evaluation.
   
• Combination productsDevices coated with drug (s) or organic (s); Products / administration of biological drugs.
  
• Methods of emerging manufacturing3D printing; making additives; additional activities or single validation and verification.
  
• Device clinical trial managementThe conduct of clinical trials, to overcome common obstacles to initiate and complete clinical trials and interaction with other stakeholders; the preparation of applications for the authorization to conduct investigational device exemption (IDE) clinical studies and respond to comments received from the FDA.
  
• Reprocessing and SterilizationReprocessing challenges in clinical settings, including understanding of the techniques and incorporating these challenges in the clinical setting for studies on labeling and validation; cleaning validation techniques instructions, disinfection or sterilization; challenges in cleaning instructions validation, disinfection or sterilization; using simulation tests, especially for validating sterilization procedures and instructions; unique sterilization methods (for example, using flexible bags, sterilizing mixed sound waves, ultraviolet light, microwave radiation).
  
• Development of in vitro diagnostic (IVD)Pre-analytical devices (ie, blood tubes) of the collection devices pathogen Micro Devices collection / transportation; General reagents, reagent manuals; testing in general, the point of common focus devices.
  
• Medical devices Instrument TrainingThe practical training of the instrument and the system; clinical implication of common laboratory tests; hands-on familiarization of medical imaging equipment in a hospital.
  
• Quality system in manufacturing environmentsThe observation of practices implemented systems based on Good Manufacturing Practices quality; manufacturing medical imaging technologies therapeutic radiology.

FDA says it will pay for the travel expenses of its employees at sites, all of which "should have a successful record of compliance with the FDA or other institution with which the FDA has concluded a Memorandum of Understanding."

RAC US Exam Question No 11

Question No 11:

When should the manufacturer of a Class III medical device expect to have an FDA establishment registration inspection?

A. Following submission of an IDE application
B. After Phase II of the IDE study
C. Prior to approval of the PMA
D. Within 2 years following the PMA approval

Answer: C

TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

After five years of negotiations, the release of the final version of the long awaited trade agreement, known as (TPP) on the Trans-Pacific Partnership, and the concessions made to the United States in the WTO TRIPS (aspects trade in intellectual property rights) agreement announced Friday both offer a new view of the pressing force and bargaining power of the pharmaceutical industry.

TPP

Early last month, a number of issues arose at a time when union business: How old organic exclusivity should be provided as part of TPP, especially for small countries like Malaysia, Vietnam and Singapore, where patients They may suffer if cheaper biosimilars are restricted for longer periods of time?

Sales representatives in the United States and Japan for a longer period of protection - 12 years - in order to protect and encourage new innovations, while others, such as Australia, fears postponing the entry biosimilars for so long that he said would increase costs.

From October leaks text TPP final documents leave some room for how countries should deal exclusively biological, providing five years of exclusivity in some cases with additional provisions and eight in the other case.

And although neither party (groups or non-profit that seeks to expand the use of cheaper drugs the pharmaceutical industry) offered praise for the final decision on market exclusivity, the transaction is clearly a victory for the industry involved in Some countries, such as Brunei and Malaysia, currently don 't offer years of protection organic market, and the US still have their 12 years of protection.

Price Information

Other parts of TPP agreement, which in some cases reflect the position of the United States, new provisions for regulating pharmaceuticals and devices from other countries such as Singapore, Brunei, New Zealand, Chile, Australia, Peru, Vietnam, Malaysia, Mexico add, Canada and Japan.

Some provisions restrict countries to use "sales prices and financial data relating to the marketing of the product" in the context of the decision to approve a particular drug or medical device for a given contract, according to an Annex to Chapter 8 on Technical Barriers to Trade

James Love, director of the NGO Knowledge Ecology International, said: "While there are arguments in favor of the concentration of the drug approval decisions within medical considerations, there is also a lack of information on drug prices , income and other data on the pharmaceutical market economy. Linking marketing authorization to provide reports on these issues should not be prohibited by the TPP ".

In addition, the TPP text adds a provision to keep pharmaceuticals markets in countries where regulators are still returning to authorize their use.

The text states that when the regulatory agency of a country requires periodic reauthorization for a pharmaceutical product that has already received a marketing authorization, the agreement requires countries to "allow the pharmaceutical product to stay on the market under conditions prior approval pending its decision on the periodic reauthorization marketing, unless a Party identifies a safety or health significantly. "

Annexe of transparency also calls on countries to provide medicines and medical device companies more rights to monitor and challenge government decisions on reimbursement of drugs - another victory for the industry.

In addition, multinational pharmaceutical and medical device companies will be happy to see another provision that limits the countries involved in TPP to require a product to be manufactured locally as a condition for approval of a product.

Collaborations Inspection

The TPP agreement could also add new provisions to regulators of medicines and health products in the countries concerned, because the agreement is to improve collaboration in the pharmaceutical inspections.

Under the agreement, regulators would be required to notify a country before conducting an inspection, "unless there is reasonable ground to believe that this could undermine the effectiveness of the inspection." And in some cases, the agreement says that countries should allow representatives of the competent authority of a country to observe the inspection of pharmaceutical manufacturing sites in other countries.

In addition, regulators carry out inspections in other countries would be required to notify the other of the results of inspections "as soon as possible after an inspection and, if the results will be announced at the end of a reasonable time before liberation. "

However, in countries like the United States, which regularly inspects manufacturing facilities abroad, the country of inspection "you are not obliged to notify their conclusions if you think your results are confidential and will not be disclosed."

out of the WTO TRIPS

In addition to the TPP Agreement, the World Trade Organization (WTO) decided on Friday to the world's least developed countries to be exempted from patent rules for 17 years.

The exemptions allow local manufacturers and other international programs to provide the necessary drugs, as HIV treatment in affected countries without having to deal with patent infringement lawsuits.

However, before this agreement 17 years, the European Commission and others have offered their support for an indefinite period exemption for these countries until they cease to be an LDC.

In a statement on the agreement on Friday, MSF, KEI, Public Citizen and others stressed that the indefinite exemption "received the unequivocal support of the almost universal civil society throughout the world, international agencies and the United Nations (WHO, UNDP, UNAIDS, UNITAID) and the European Union declared unanimously by the WTO members, with the exception of the United States. If the Council for TRIPS of the WTO attaches to the least developed countries to their valid claims and wished, it would have shown the world that the WTO take steps to protect the poor and most vulnerable measures. "

The groups also "an urgent appeal to all least developed countries to actively use the political space created this new period of transition and, therefore, must take immediate steps to amend their national laws to exclude protection products and pharmaceutical patents protection of test data with the explicit provisions that would be up to January 1, 2033 or the end of this transition period after which may be granted by the TRIPS Council of the WTO. "

RAC US Exam Question No 10

Question No 10:

In a medical device company, which of the following units has ultimate responsibility for the integrity of the data and the quality of the product:

A. Quality Assurance
B. Quality Control
C. Management
D. Regulatory Compliance

Answer: C

RAC US Exam Question No 9

Question No 9:

A new Class II device with electrical components was subjected to extensive standard testing such as the International Electrotechnical Commission (IEC) series (recognized conformance standard). The tests were conducted by a third party. Which route of submission is the most suitable for this device?

A. Traditional 510k
B. Special 510k
C. Abbreviated 510k
D. PMA

Answer: C

FDA, Industry See Progress in MDUFA IV Negotiations.

At the second meeting it focuses on the fourth iteration of user fees for medical devices (MDUFA) agreements for 2017 as the Food and Drug Administration (FDA) and industry agreement reiterated that the overall program is improved and heads in a positive direction.
The negotiations focus on the use of a system whereby medical device companies pay fees to the FDA to register their establishments and list their devices with the agency. The fees help increase the effectiveness of the regulatory process of the FDA, with the aim of reducing the time needed to bring safe and effective devices on the market.

Negotiations

In early October, employees of the FDA Center for Devices and Radiological Health (CDRH) met with representatives of industry groups including AdvaMed Industry, Medical Imaging and Technology Alliance (MITA), the American Clinical Laboratory Association ( ACLA) and the Medical Device Manufacturers Association (MDMA)
The two sides discussed the FDA's response to an analysis of requests for pre-investigational device exemption (IDE) has asked the industry, examined CDRH information systems for pre-marketing review and discussed the implementation of the MDUFA recommendations Booz Allen Hamilton II / III evaluation and additional financial analysis.

Pre-bidding for FDI

In explaining the results of a pre-bid for FDI analysis, based on a sample audit of fiscal year 2013 and part of 2014, the FDA said it determined that the IDE with previous memories have a higher probability that the first cycle approval.
An investigational device exemption (IDE) allows the device to be used in a clinical study to collect data on safety and efficacy. Clinical trials are most often carried out in support of an application for premarket approval, while a small percentage of the 510 (k) s require clinical data to support the application.
"Although the available data support the conclusion that FDI with pre-memories have a greater chance of approval, the significance of this finding is complicated by the fact that the data shows that it may take more time to study an IDE approval when was preceded by a pre-bid, "the FDA said.
FDA noted the increase of time is often due to the pre-bid is associated with the most difficult IDE studies.
Another key finding was that the presentation of the FDA and Q-novo workload has increased. Q-arguments refer to the documents submitted by the promoters of feedback from the FDA called before a meeting IDE. And de novo sort option is an alternative way of categorizing new low to moderate risk devices that were automatically placed in Class III after receiving a "not substantially equivalent" decision in response to a (k) 510.
The FDA also describes the trend in the number of submissions and pre-submission of thematic meetings (SIMS) increase, despite an increase in submissions for which there is no charge, the FDA said it continues to meet its objectives performance.
The agency also said Examiners provide information before the presentation pre mostly for fiscal year 2015 than in previous years, when the industry enjoyed meetings.
As for the orientation, the industry also welcomed the efforts of the FDA to provide clarity through revisions guidance documents, even if "can inject more uncertainty because many are associated with new initiatives that require staff FDA and the industry time to respond. " CAWA, for example, expressed concern about the use of guidelines rather than formal comments and regulations for major policy changes.

Evaluation MDUFA

Also at the meeting, the FDA CDRH presented a summary of the implementation of a plan to address the recommendations of MDUFA II / III evaluation of Booz Allen Hamilton, which includes 11 recommendations for FDA to improve the efficiency of time and consideration a review of the presentation of the device process.
The five categories of recommendations are Quality Management, Evaluation of the review process, the evaluation of infrastructure and workload Tools, evaluation of training programs, evaluation and billing.
CDRH said it has completed the groundwork for seven of the 11 recommendations, including the four projects on the recommendation of quality management. Other preliminary actions met in December 2015, the FDA should.

Finance

The FDA said there was a decrease of the budgetary authority (BA) Credits for medical devices for the fiscal year 2013 due to the kidnapping, and the agency has met the trigger on credit line devices and radiation health budget annually MDUFA III so far.
FDA has agreed to provide additional information about the 510 (k) program novo and industry at the next meeting on 18 November.