Thursday, January 21, 2016
Sunday, January 17, 2016
How Do Two or More Packaged Devices Need to Comply With the UDI Rule? FDA Explains.
The Food and Drug Administration (FDA) is trying to shed further light on cases where two or more medical devices packaged together in what the agency calls a "comfort kit" would have to meet unique device identifiers (UDI) labeling requirements.
Under the draft guidelines, convenience kit, the administration tries to solve, "applies to two or more different medical devices packaged together for convenience of the user when they are destined to remain together and not full, substituted, reconditioned, sterilized, or otherwise or modified before the equipment is used by an end user. "
Individual devices in these kits are exempt from the labeling requirement, as long as UDI is included on the label on the packaging of the kit.
The new position of the FDA, which he said is "a change in policy," clearly indicates that since the publication of the rule of UDI, the agency decided that the term "comfort kit" does not include implantable devices and instruments that is "provided by the label in games or trays as sterile and sterilized and repeatedly reconfigured (or cleaned and sterilized) before use."
The agency explained its change of opinion pointing out that the main purpose of Rule UDI is to provide a system that can adequately controlled and identify medical devices through the distribution and use, especially about adverse events.
The Food and Drug Administration (FDA) is trying to shed further light on cases where two or more medical devices packaged together in what the agency calls a "comfort kit" would have to meet unique device identifiers (UDI) labeling requirements.
Under the draft guidelines, convenience kit, the administration tries to solve, "applies to two or more different medical devices packaged together for convenience of the user when they are destined to remain together and not full, substituted, reconditioned, sterilized, or otherwise or modified before the equipment is used by an end user. "
Individual devices in these kits are exempt from the labeling requirement, as long as UDI UDI is included on the label on the packaging of the kit.
The new position of the FDA, which he said is "a change in policy," clearly indicates that since the publication of the rule of UDI, the agency decided that the term "comfort kit" does not include implantable devices and instruments that is "provided by the label in games or trays as sterile and sterilized and repeatedly reconfigured (or cleaned and sterilized) before use."
The agency explained its change of opinion pointing out that the main purpose of Rule UDI is to provide a system that can adequately controlled and identify medical devices through the distribution and use, especially about adverse events.
Under the draft guidelines, convenience kit, the administration tries to solve, "applies to two or more different medical devices packaged together for convenience of the user when they are destined to remain together and not full, substituted, reconditioned, sterilized, or otherwise or modified before the equipment is used by an end user. "
Individual devices in these kits are exempt from the labeling requirement, as long as UDI is included on the label on the packaging of the kit.
The new position of the FDA, which he said is "a change in policy," clearly indicates that since the publication of the rule of UDI, the agency decided that the term "comfort kit" does not include implantable devices and instruments that is "provided by the label in games or trays as sterile and sterilized and repeatedly reconfigured (or cleaned and sterilized) before use."
The agency explained its change of opinion pointing out that the main purpose of Rule UDI is to provide a system that can adequately controlled and identify medical devices through the distribution and use, especially about adverse events.
The Food and Drug Administration (FDA) is trying to shed further light on cases where two or more medical devices packaged together in what the agency calls a "comfort kit" would have to meet unique device identifiers (UDI) labeling requirements.
Under the draft guidelines, convenience kit, the administration tries to solve, "applies to two or more different medical devices packaged together for convenience of the user when they are destined to remain together and not full, substituted, reconditioned, sterilized, or otherwise or modified before the equipment is used by an end user. "
Individual devices in these kits are exempt from the labeling requirement, as long as UDI UDI is included on the label on the packaging of the kit.
The new position of the FDA, which he said is "a change in policy," clearly indicates that since the publication of the rule of UDI, the agency decided that the term "comfort kit" does not include implantable devices and instruments that is "provided by the label in games or trays as sterile and sterilized and repeatedly reconfigured (or cleaned and sterilized) before use."
The agency explained its change of opinion pointing out that the main purpose of Rule UDI is to provide a system that can adequately controlled and identify medical devices through the distribution and use, especially about adverse events.
Examples:
A first aid kit containing bandages, cold compresses, scissors and an oral thermometer is regarded as a practical kit for compliance purposes UDI.
However, a non-orthopedic tray sterile or device together at the time of writing the rule UDI was seen as a kit, is now not considered a kit of convenience and all its components and devices must have an IDU because " devices are not intended to remain packed together, but are intended to be decompressed before being placed on trays for surgery and sterilized before use, with periodic replacement tray 185 for subsequent surgery and recovered ".
But anterior cruciate ligament (ACL) disposable kit consisting of a single use sterile instruments such as guide child guide pins of the tip of the drill, taken tunnel, and transplantation which are used for ACL reconstructive procedures and are packed and sealed in a single container it is regarded as a practical kit for compliance purposes UDI.
Finally, FDA proposed example of reusable medical devices packed together, which would not be convenient kit.
However, a non-orthopedic tray sterile or device together at the time of writing the rule UDI was seen as a kit, is now not considered a kit of convenience and all its components and devices must have an IDU because " devices are not intended to remain packed together, but are intended to be decompressed before being placed on trays for surgery and sterilized before use, with periodic replacement tray 185 for subsequent surgery and recovered ".
But anterior cruciate ligament (ACL) disposable kit consisting of a single use sterile instruments such as guide child guide pins of the tip of the drill, taken tunnel, and transplantation which are used for ACL reconstructive procedures and are packed and sealed in a single container it is regarded as a practical kit for compliance purposes UDI.
Finally, FDA proposed example of reusable medical devices packed together, which would not be convenient kit.
Thursday, January 14, 2016
RAC US Exam Question No 20
Question No 20:
An IVD submission could be submitted as a(n)?A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k)
Answer: D
FDA Lacks Reliable, Accessible Postmarket Data on Drugs, GAO Says
The Food and Drug Administration (FDA) does not have a reliable, easily accessible on the issues of security studies and post marketing of drugs approved by the expedited review of routes, said the Government Accountability Office in a report published on Thursday.
The report has dug in the FDA Center for Drug Evaluation and Data Research (CDER), which received nearly 1,000 applications for the designation of the highway and advanced designation therapy (the other two accelerated programs for review new drug approval and review of priority) are accelerated and were mostly of cancer drugs.
Among more than 770 quick applications runway designation since fiscal year 2007, the FDA granted approximately two thirds of these applications, and over 220 requests for appointments advanced therapy since this route was established in July 2012 agency denied more than half of these requests.
However, the GAO found that assessments made by the CDER data to monitor security events have revealed problems with the integrity, timeliness and accuracy of the data.
Specifically, the GAO said CDER indicated that a large number of potential security problems were not registered in its database, known as document archiving, reporting and monitoring of Regulations (DARRTS). Among the probable meetings criteria for security issues tracked CDER has identified 144 issues that were not formally followed DARRTS.
In addition, GAO found that more than half of the opinions on the observations sponsors associated with about 1,400 post-marketing studies FDA requested or required March 2008 to September 2013 will be delayed or late.
"These problems as well as problems with the way data is recorded that impede accessibility, prevented the FDA published reports required by law in some potential safety issues, and post-marketing studies on time timely, and limits the ability of the agency to conduct post-marketing drug safety monitoring systematically, "Gao said.
The Office found that the FDA does not intend to use these data to inform their monitoring of its accelerated programs, for example, if drugs that use a then accelerated program were associated with problems security followed in levels or types that are approved drugs differ from Standard Lead FDA.
In October 2015, the FDA had not issued the required annual reports with data on post-marketing studies for 2013 and 2014.
"FDA officials said they had decided to delay the publication of reports is mainly due to the internal evaluation of CDER post-marketing data and subsequent to solve data problems have been identified efforts to study," said the report.
Rep. Rosa DeLauro (D-CT), which commissioned the GAO report, said in a statement on Thursday: "The GAO report confirms my worst fear, that the FDA does not have the basic resources and leadership, ensuring that drugs are brought to market quickly really safe and effective. "
In its defense, the FDA said it would like to clarify three issues related to a draft report.
First, the agency says that all drugs must meet the same regulatory standards for safety and effectiveness, regardless of their accelerated state. Second, medicines authorized via accelerated not necessarily require different postmarketing other drugs approved by conventional means studies and, finally, the FDA says it is working to address "the challenges of administrative supervision his work in the post-market safety. "
The report has dug in the FDA Center for Drug Evaluation and Data Research (CDER), which received nearly 1,000 applications for the designation of the highway and advanced designation therapy (the other two accelerated programs for review new drug approval and review of priority) are accelerated and were mostly of cancer drugs.
Among more than 770 quick applications runway designation since fiscal year 2007, the FDA granted approximately two thirds of these applications, and over 220 requests for appointments advanced therapy since this route was established in July 2012 agency denied more than half of these requests.
However, the GAO found that assessments made by the CDER data to monitor security events have revealed problems with the integrity, timeliness and accuracy of the data.
Specifically, the GAO said CDER indicated that a large number of potential security problems were not registered in its database, known as document archiving, reporting and monitoring of Regulations (DARRTS). Among the probable meetings criteria for security issues tracked CDER has identified 144 issues that were not formally followed DARRTS.
In addition, GAO found that more than half of the opinions on the observations sponsors associated with about 1,400 post-marketing studies FDA requested or required March 2008 to September 2013 will be delayed or late.
"These problems as well as problems with the way data is recorded that impede accessibility, prevented the FDA published reports required by law in some potential safety issues, and post-marketing studies on time timely, and limits the ability of the agency to conduct post-marketing drug safety monitoring systematically, "Gao said.
The Office found that the FDA does not intend to use these data to inform their monitoring of its accelerated programs, for example, if drugs that use a then accelerated program were associated with problems security followed in levels or types that are approved drugs differ from Standard Lead FDA.
In October 2015, the FDA had not issued the required annual reports with data on post-marketing studies for 2013 and 2014.
"FDA officials said they had decided to delay the publication of reports is mainly due to the internal evaluation of CDER post-marketing data and subsequent to solve data problems have been identified efforts to study," said the report.
Rep. Rosa DeLauro (D-CT), which commissioned the GAO report, said in a statement on Thursday: "The GAO report confirms my worst fear, that the FDA does not have the basic resources and leadership, ensuring that drugs are brought to market quickly really safe and effective. "
In its defense, the FDA said it would like to clarify three issues related to a draft report.
First, the agency says that all drugs must meet the same regulatory standards for safety and effectiveness, regardless of their accelerated state. Second, medicines authorized via accelerated not necessarily require different postmarketing other drugs approved by conventional means studies and, finally, the FDA says it is working to address "the challenges of administrative supervision his work in the post-market safety. "
Sunday, January 10, 2016
MHRA Calls for Continued Quarantine of Silimed Implants
Regulatory Medicines and Health Products UK (MHRA) on Agency, reiterated his call to quarantine implants manufactured by Silimed Brazil, saying it is still trying to determine if there are potential health risks associated with the particles on the surface devices.
The MHRA warning comes a day after Jeffrey Nugent, President and CEO Sientra, Silimed a supplier of products to the United States, sent a letter to the plastic surgeons advising them to an independent review, other products Sientra concluded that pose no risk for patients.
"We have been in constant communication with the [US Food and Drug Administration] and on the basis of the performance of this test, we have met our goal of presenting data to the FDA by the end of 2015," Nugent said.
The MHRA warning comes a day after Jeffrey Nugent, President and CEO Sientra, Silimed a supplier of products to the United States, sent a letter to the plastic surgeons advising them to an independent review, other products Sientra concluded that pose no risk for patients.
"We have been in constant communication with the [US Food and Drug Administration] and on the basis of the performance of this test, we have met our goal of presenting data to the FDA by the end of 2015," Nugent said.
Context
In September 2015, the regulators of the Member States and EU MHRA suspended the CE mark for medical devices manufactured by Silimed after a German notified body, known as TÜV SÜD, on the surfaces of the particles Some of the devices discovered.
Silimed, which claims to be the largest manufacturer of silicone implants and the largest manufacturer of breast implant in South America, produces a catalog of more than 5000 implants for plastic surgery, bariatric surgery (including strips and gastric balloons), urology , general surgery and other invasive silicone devices in more than 75 countries.
Therapeutic Goods Administration of Australia (TGA), HSA and Swissmedic Singapore also recommends that surgeons do not use implants society.
FDA, meanwhile, said in October that it agreed with the recommendations made by Sientra adopt a precautionary approach until more is known about implants. Sientra temporarily halted all US sales of these devices when international regulators have expressed reservations.
Silimed, which claims to be the largest manufacturer of silicone implants and the largest manufacturer of breast implant in South America, produces a catalog of more than 5000 implants for plastic surgery, bariatric surgery (including strips and gastric balloons), urology , general surgery and other invasive silicone devices in more than 75 countries.
Therapeutic Goods Administration of Australia (TGA), HSA and Swissmedic Singapore also recommends that surgeons do not use implants society.
FDA, meanwhile, said in October that it agreed with the recommendations made by Sientra adopt a precautionary approach until more is known about implants. Sientra temporarily halted all US sales of these devices when international regulators have expressed reservations.
MHRA Update
On Friday, the MHRA warned that although Silimed said the devices pose no risk to patients, research the regulator has not yet been completed.
"We are aware that Silimed have published papers suggesting that there is no risk to patients, but has yet to be determined through our assessment test" MHRA said. "We will communicate the conclusions shortly. Meanwhile our previous advice that the devices should be quarantined still applies."
This contrasts with the warning letter Nugent of only a few days before.
"Let me recall that all regulatory agencies that have participated in the Silimed review, including the FDA, has always said that there are no reports of adverse events related to this issue and none of the patients of health risks have been identified," said Nugent . Shares of the company rose more than 10% on Friday.
"We are aware that Silimed have published papers suggesting that there is no risk to patients, but has yet to be determined through our assessment test" MHRA said. "We will communicate the conclusions shortly. Meanwhile our previous advice that the devices should be quarantined still applies."
This contrasts with the warning letter Nugent of only a few days before.
"Let me recall that all regulatory agencies that have participated in the Silimed review, including the FDA, has always said that there are no reports of adverse events related to this issue and none of the patients of health risks have been identified," said Nugent . Shares of the company rose more than 10% on Friday.
Wednesday, January 6, 2016
RAC US Exam Question No 19
Question No 19:
A US medical device contract manufacturer has customers for whom it manufactures medical device components (parts) and finished medical devices. To date, all products have been either parts for Class II medical devices or Class II finished medical devices. The manager of new business contacts the regulatory manager to assess the impact of a possible new customer involving a Class III device. What is the first question the regulatory manager should as in order to begin assessing the impact of Class III on plant operpations?A. Is it a sterile device?
B. Is it a component or device that would be manufactured?
C. Is it an implantable device?
D. Is it a single use device?
Answer: B
Sunday, January 3, 2016
FDA Warns Sun’s India Plant Over Sterility Concerns
Aseptic and sterility of serious violations, including water damage and leaks in parenteral manufacturing areas have been documented by the Food and Drug Administration (FDA) in the last warning letter to Sun Pharmaceutical manufacturing plant in Halol, India.
Since the inspection in September 2014, the FDA withheld approval of future products Halol plant.
The company was quoted in a warning letter separately in May 2014 on issues of integrity of data (records of good practice to manufacture garbage bags were found) in its manufacturing plant in Gujarat, India, which is also included in the import alert list of the FDA.
With regard to this last warning, Sun Pharma said it has already responded to comments "with a strong consolidation process is still ongoing, with major investments in automation and training to improve their quality systems."
"During the inspection, the Deputy Director General and the quality assurance (QA) manager confirmed that the discarded bottles were rejected during the filling process of the media without assignable causes recorded or documented," the FDA said.
In addition, the company did not make adequate ventilation studies to determine how the air movement and staff during aseptic operations pose a risk of infertility.
FDA asks Sun to perform a risk assessment for the practice of rejecting the means of filling bottles unlimited justification and acceptance in writing, as well as standard operating procedure revised media is filled, specifically relating to the amendments on the rejection and research of these non INTEGRAL bottles.
The company also failed to provide information on unknown impurities found within six months of accelerated stability test (for later distribution to US products), attributed to flaws in the product of degradation of the business process, but Sun It has not identified the specific impurities or its root causes.
In addition, Sun missing audit trails or other controls track people who access levels programmable logic controller or the man-machine interface equipment.
The FDA asked the company to address the "impact on the control environment since the beginning of flight and for the next six months. Include all cases that have been identified fungal or bacterial spores coaches, and also explain the extent that microbial identification were performed in these areas. "
Since the inspection in September 2014, the FDA withheld approval of future products Halol plant.
The company was quoted in a warning letter separately in May 2014 on issues of integrity of data (records of good practice to manufacture garbage bags were found) in its manufacturing plant in Gujarat, India, which is also included in the import alert list of the FDA.
With regard to this last warning, Sun Pharma said it has already responded to comments "with a strong consolidation process is still ongoing, with major investments in automation and training to improve their quality systems."
The cover letter
FDA documents many infertility, particularly in the way in which the media recordings meet failed to include a specific description by Sun rejected bottles some batches."During the inspection, the Deputy Director General and the quality assurance (QA) manager confirmed that the discarded bottles were rejected during the filling process of the media without assignable causes recorded or documented," the FDA said.
In addition, the company did not make adequate ventilation studies to determine how the air movement and staff during aseptic operations pose a risk of infertility.
FDA asks Sun to perform a risk assessment for the practice of rejecting the means of filling bottles unlimited justification and acceptance in writing, as well as standard operating procedure revised media is filled, specifically relating to the amendments on the rejection and research of these non INTEGRAL bottles.
The company also failed to provide information on unknown impurities found within six months of accelerated stability test (for later distribution to US products), attributed to flaws in the product of degradation of the business process, but Sun It has not identified the specific impurities or its root causes.
In addition, Sun missing audit trails or other controls track people who access levels programmable logic controller or the man-machine interface equipment.
Water Leaks
An FDA investigators also documented water leaks, stains and damage in the ceiling area of manufacturing parenteral personal broker. Buckets collecting water leaking from the ceiling in the manufacturing area were also found.The FDA asked the company to address the "impact on the control environment since the beginning of flight and for the next six months. Include all cases that have been identified fungal or bacterial spores coaches, and also explain the extent that microbial identification were performed in these areas. "
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