The FDA also published an update to its Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records (Edition 4), to ensure the guidance is consistent with the new FSMA requirements.

Below are the links to the new rule and guidance documents:

• Interim Final Rule: Establishment, Maintenance, and Availability of Records: Amendment to Record
• Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
• Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) 

Also from the FDA a question and answer on the new rule:

FDA Records Access Authority Under Sections 414 and 704 Federal Food, Drug, & Cosmetic Act 

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction

This guidance document provides updated information pertaining to the Food and Drug Administration’s (FDA) authority to access and copy records under sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is a revision of FDA’s November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for records access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.”

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word shouldin Agency guidance means that something is suggested or recommended, but not required.

II. Background

The FDA Food Safety Modernization Act (FSMA) (PL 111-353) was signed into law on January 4, 2011. Section 101 of FSMA amends section 414(a) and 704(a)(1)(B) of the FD&C Act (21 U.S.C. 350c(a) and 374(a)(1)(B)). Section 414 was originally added to the FD&C Act by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188). Prior to the passage of FSMA, section 414(a) of the FD&C Act provided the Secretary (by delegation FDA) with access to records relating to food that was reasonably believed to be adulterated and present a threat of serious adverse health consequences or death to humans or animals. FSMA expands FDA’s access to records beyond records relating to the specific suspect article of food to records relating to any other article of food that the FDA reasonably believes is likely to be affected in a similar manner. In addition, FDA can now access records if FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. The Bioterrorism Act also amended section 704(a)(1)(B) of the FD&C Act to include a cross-reference to section 414. Section 101 of FSMA amends this section, which pertains to factory inspections, by updating the cross-reference to refer to the amended version of section 414(a).

FDA’s access to records under section 414 is separate from previously existing routine records access provided in commodity specific regulations, such as the Low-Acid Canned Food regulations (21 CFR part 113), the Acidified Food regulations (21 CFR part 114), the Juice Hazard Analysis and Critical Control Point (HACCP) Systems regulations (21 CFR part 120), the Fish and Fishery Products regulations (21 CFR part 123), and the Infant Formula regulations (21 CFR part 106). These commodity specific record access regulations were not amended by FSMA.

III. Questions and Answers

1. Does FDA’s records access authority under sections 414(a) and 704(a) of the FD&C Act apply to records relating to both human food and animal feed?

Yes. The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article, as defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)).

2. Does FDA’s records access authority under sections 414(a) and 704(a) apply to both domestic and foreign persons?

Yes. FDA’s records access authority under sections 414(a) and 704(a) applies to both domestic and foreign persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import articles of food when the circumstances in section 414(a)(1) or (2) of the FD&C Act are met. A person’s refusal to permit FDA to access and copy any record as required by section 414(a) or 704(a) is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)). The term “person” has the same meaning as defined in section 201(e) of the FD&C Act to include individual, partnership, corporation, and association.

FDA prefers that requested records relating to the manufacture, processing, packing, transportation, distribution, receipt, holding or importation of food that is intended for or enters the U.S. supply chain to be provided to the Agency in English.

3(a).   Under what circumstances may FDA access and copy records under section 414(a) of the FD&C Act?

FDA may access and copy records from domestic and foreign persons who manufacture, process, pack, transport, distribute, receive, hold, or import food if:

• (1) FDA has a reasonable belief that the food, and any other food that FDA reasonably believes is likely to be affected in a similar manner,

a) is adulterated, and

b) presents a threat of serious adverse health consequences or death to humans or animals.

• Or, (2) FDA believes that there is a reasonable probability that use of or exposure to the food, and any other food that the FDA reasonably believes is likely to be affected in a similar manner will cause serious adverse health consequences or death to humans or animals.

3(b). What records may FDA access and copy if the circumstances under section 414(a) of the FD&C Act are met?

• If the circumstances in (1) are met, FDA may access and copy the records that are needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals
• If the circumstances in (2) are met, FDA may access and copy the records that are needed to assist FDA in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to human or animals.

4. When is FDA likely to exercise its authority under section 414(a) and 704(a) of the FD&C Act to access and copy records?

FDA may request to access and copy records whenever the requirements of section 414(a)(1) or (2) are satisfied, but requests are most likely to occur when FDA becomes aware of:

• Reportable food reports, as defined in section 417(a)(2) of the FD&C Act [21 U.S.C. 350f(a)(2)]
• Foodborne outbreaks
• Epidemiological evidence which implicates food causing illness or death
• Product recalls
• Adverse event reports
• Consumer complaints
• Situations in which specific foods (or other foods that are reasonably likely to be affected in a similar manner) present a threat of serious adverse health consequences or death to humans or animals

5(a).  What are some examples of situations in which food may cause serious adverse health consequences or death to humans or animals?

The following are some examples of situations in which food may cause serious adverse health consequences or death to humans or animals:

• Peanut butter contaminated with Salmonella
• Under-processed canned chili that contains Clostridium botulinum toxin
• Smoked salmon contaminated with Listeria monocytogenes
• Cake mix that contains milk that is not declared in the ingredient statement on the label
• Candy contaminated with peanuts because of cross-contact with another food that contained peanuts as an ingredient
• Baby food that poses a choking hazard
• Horse feed contaminated with elevated levels of monensin
• Pet food contaminated with elevated levels of melamine and cyanuric acid
• Sheep feed that contains elevated levels of copper
• Swine feed that contains elevated levels of selenium

5(b). What are some examples of situations in which food is likely to be affected in a similar manner and may cause serious adverse health consequences or death to humans or animals?

The following are some examples of situations in which food can be considered likely to be affected in a similar manner and may cause serious adverse health consequences or death to humans or animals:

• Salmonella outbreak in which, based on epidemiological data, multiple foods are initially implicated as potential sources of the Salmonella
• Articles of food prepared or packed on an identical processing line as another article of food which may cause serious adverse health consequences or death to humans or animals
• Articles of food that are processed in shared-use equipment and that equipment was used to process an article of food which may cause serious adverse health consequences or death to humans or animals
• Articles of food that were prepared, packed or held under similar conditions as an article of food which may cause serious adverse health consequences or death to humans or animals

6. What records may FDA access and copy under sections 414(a) and 704(a) of the FD&C Act?

FDA’s authority under sections 414(a) and 704(a) of the FD&C Act applies to records that are required to be kept by regulation under section 414(b), as well as any other records related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of the food believed to be affected and any other article of food believed to be affected in a similar manner. This applies to records maintained by or on behalf of such person, in any format (including paper and electronic formats), and at any location. FDA recognizes that some persons store their records at a location other than the facility where the covered activities take place. Because the circumstances of each particular event vary, the scope of an FDA request for records may vary in each situation.

Examples of records that FDA can access and copy include:

• Manufacturing records
• Raw materials (ingredients and packaging) receipt records
• Product distribution records
• Product inventory records
• Test records
• Recall records
• Reportable food records
• Customer distribution lists
• Complaint and adverse event records

7. What records may FDA not access and copy under sections 414(a) and 704(a) of the FD&C Act?

FDA’s authority to access records under sections 414(a) and 704(a) of the FD&C Act does not apply to the following records:

• Records from farms, as defined in 21 CFR 1.328 – Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling produce are considered part of harvesting. The term “farm” includes:

1. Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership: and

2. Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

• Records from restaurants, as defined in 21 CFR 1.328 – Restaurant means a facility that prepares and sells food directly to consumers for immediate consumption. “Restaurant” does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers. Facilities in which food is directly provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens, are restaurants. Pet shelters, kennels, and veterinary facilities in which food is directly provided to animals are restaurants.
• Records relating to food that is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.)
• Recipes, as defined in 21 CFR 1.328 – A “recipe” is the formula, including ingredients, quantities, and instructions necessary to manufacture a food. Because a recipe must have all three elements, a list of the ingredients used to manufacture a food, without quantity information and manufacturing instructions, is not a recipe.
• Financial data
• Pricing data
• Personnel data

• Research data
• Sales data other than shipment data regarding sales

8.  What actions may FDA take when a firm refuses to permit access to records?

The refusal to permit access to or copying of records requested under section 414(a) of the FD&C Act is a prohibited act under section 301(e) of the FD&C Act [21 U.S.C. 331(e)]. In response to such a refusal, FDA may initiate civil or criminal action, as necessary. In addition, FDA may refuse admission of food offered for import into U.S. commerce by a firm that refused to permit FDA to access records.

Depending on the situation, FDA may initiate additional administrative, judicial, or other action, as appropriate, in conjunction with a records access request. These additional actions are distinct from a records access request and the existence of a records access request does not alter the process or timeframes established for these additional actions. Moreover, refusal to permit FDA access to records is not a prerequisite for using these additional actions. Such additional actions may include:

• Suspension of the food facility’s registration, thus preventing the firm from importing or exporting food or introducing food into interstate or intrastate commerce
• Administrative detention of the food to control its movement
• Seizure of the food
• Issuance of a mandatory recall order for the food
• Injunction against the firm

9.  How will FDA maintain the confidentiality of any protected information in records it obtains?

Information obtained under the records access provisions of sections 414(a) and 704(a) of the FD&C Act may include, but is not limited to, a company’s non-public confidential commercial or trade secret information. Several statutes (e.g., Trade Secrets Act (18 U.S.C. 1905), FD&C Act (21 U.S.C. 331(j)), the Freedom of Information Act, (5 U.S.C. 552) and the agency’s information disclosure regulations at 21 CFR Parts 20 and 21 govern the agency’s disclosure of information to the public. For both foreign and domestic firms, FDA personnel will comply with all applicable protections, procedures, and legal requirements against the unauthorized disclosure of non-public information, such as any trade secret or confidential commercial information. FDA personnel may disclose non-public information otherwise protected from disclosure to the public, if that disclosure is permitted by law and FDA’s procedures (see e.g. 21 U.S.C. 375(b)). For example, FDA’s regulations (set forth in 21 CFR Parts 20 and 21) permit agency officials to disclose certain non-public information to other federal, state, local, or foreign government officials, or to FDA’s contractors, when that disclosure is carried out according to law and FDA’s procedures.

The FDA is committed to protecting the nation’s public health from contaminants in our food supply and has been monitoring for arsenic content for more than 20 years.

Because arsenic is naturally occurring in soil and was used for many years in pesticides, we know there are trace amounts of arsenic in many foods. In response, FDA has expanded its surveillance activities in rice to ensure that consumers are protected. In fact, beginning in October 2011, FDA began a further study of arsenic in rice and rice products in order to determine the level and types of arsenic typically found in these products. The study is scheduled to complete in Spring 2012.

FDA is not aware of any brand of infant formula containing organic brown rice syrup (OBRS). One brand of “toddler formula” uses OBRS as a sweetener. This product is labeled for use in children older than 12 months, however the label also states that a health care professional should be consulted before using this product for infants under 12 months of age.

Arsenic in infant formula and cereal bars;
Arrests at a Butterball facility in North Carolina;
New calorie limit by Mars Inc. on chocolate candy;
Jimmy Johns E. Coli recall;
Demand for organic milk surges;
EU and US recognize organic standards as equivalent; and
‘Sin tax in Massachusetts’ tax on sugary candy and drinks.

Guest Contributior: Michael “Mick” Guerini, Microbiologist and Technical Writer

A whole-genome investigation of samples from Europe’s Escherichia coli O104:H4 outbreak linked to fenugreek sprout seeds was recently reported in the Proceedings of the National Academy of Sciences(PNAS).  Using whole-genome sequencing, a team led by researchers from Harvard School of Public Health (HSPH) and the Broad Institute traced the path of the E. coli outbreak that sickened thousands and killed over 50 people.

 “A genome contains the record of a strain’s evolutionary history, so by looking at the differences between the genomes of multiple bacteria from an outbreak we can get really useful clues about what happened in the outbreak. In this way, tracking outbreaks is like detective work, and this approach will be a powerful tool in trying to understand future outbreaks,” said lead author Yonatan Grad, a research fellow in the Center for Communicable Disease Dynamics, Department of Epidemiology at HSPH and infectious disease physician at Brigham and Women’s Hospital in Boston.

European investigators, using traditional epidemiological methods, traced the outbreaks to a shipment of seeds from Egypt that arrived in Germany in December 2009. Based on conventional molecular epidemiological analysis, the E. coli strains from the outbreaks in Germany and France appear identical.  This finding by the research team is important because it highlights the need for combining epidemiological work with molecular analysis.

However, by harnessing the Broad Institute’s expertise in whole-genome sequencing and analysis, the researchers were able to determine that there were small, but measurable, differences among the isolates. They made two surprising findings: All the strains connected to the larger German outbreak were found to be nearly identical, while the strains in France showed greater diversity; and the German isolates appeared to be a subset of the diversity seen in the French isolates.

“If genomes have fewer differences than we expect, like the German outbreak, it suggests that the outbreak might have passed through a bottleneck. A bottleneck might be something like disinfection procedures that killed most but not all of the bugs, or maybe passage through a single infected individual,” said Hanage.  Another hypothesis offered by the researchers is that there was uneven distribution of diversity in the original shipment of contaminated seeds.

As costs for genomic sequencing decline, these tools, combined with traditional epidemiological techniques, can provide greater insight into the emergence and spread of infectious diseases and will help guide: food safety testing guidelines, food safety regulations, food processing and manufacturing as well as preventive public health measures.

Paper cited — “Genomic Epidemiology of the Escherichia coli O104:H4 Outbreaks in Europe, 2011,” Yonatan H. Grad, Marc Lipsitch, Michael Feldgarden, Harindra M. Arachchi, Gustavo C. Cerqueira, Michael FitzGerald, Paul Godfrey, Brian J. Haas, Cheryl Murphy, Carsetn Russ, Sean Sykes, Bruce J. Walker, Jennifer R. Wortman, Sarah Young, Qiandong Zeng, Amr Abouelleil, James  Bochicchio, Sara Chauvin, Timothy DeSmet, Sharvari Gujja, Caryn McCowan, Anna Montmayeur, Scott Stellman, Jakob Frimodt-Moller, Andreas M. Petersen, Carsten Struve, Karen A. Krogfelt, Edouard Bingen, Francois-Xavier Weill, Eric S. Lander, Chad Nusbaum, Bruce W. Birren, Deborah T. Hung, William P. Hanage, Proceedings of the National Academy of Sciences, online February 6, 2012

(Source of Information — Harvard School of Public Health, February 6, 2012 Press release)

Consumer Reports cites research at Dartmouth College as finding arsenic in some foods that use organic brown rice syrup as a sweetener, including infant formula and cereal bars. As the Dr. Oz publicity of arsenic in apple juice taught us there are two types of arsenic - organic and inorganic, the latter being a human carcinogen at some threshold (read more). The majority of the detected arsenic in the Dartmouth study, a contaminant often found in rice, was the type that is known to be a human carcinogen.

Important findings of the study, published online Feb. 16 by the peer-reviewed journal Environmental Health Perspectives include:

• Two of 17 infant formulas tested listed organic brown rice syrup as the primary ingredient. One had a total arsenic concentration that was six times the federal limit of 10 parts per billion (ppb) for total arsenic in bottled or public drinking water. This is particularly worrisome for babies because they are especially vulnerable to arsenic’s toxic effects due to their small size and the corresponding arsenic consumption per pound of body weight.
• Twenty-two of 29 cereal bars or energy bars tested listed at least one of these four rice products—organic brown rice syrup, rice flour, rice grain or rice flakes – among the top five ingredients. The seven other bars were among the lowest in total arsenic, ranging from 8 to 27 ppb, while those containing syrup or other forms of rice ranged from 23 to 128 ppb.
• Tests of high-energy products known as “energy shots” that are used by endurance athletes and others showed that one of the three gel-like blocks contained 84 ppb of total arsenic, while the other two contained 171 ppb.

The Dartmouth researchers conclude that given the increasing prevalence of hidden arsenic in food, “there is an urgent need for regulatory limits on As (arsenic) in food.” They also cited Consumer Reports’ recent investigation, which found elevated levels of arsenic in apple and grape juices, as further evidence that U.S. consumers are being exposed to worrisome concentrations of arsenic in foods and beverages. Legislation was introduced Feb. 8 in the U.S. House of Representatives, the APPPLE Juice Act called on the Food and Drug Administration to establish standards for both arsenic and lead in fruit juices; there are currently no federal thresholds for arsenic in juices or most foods.

Consumer Reports cites studies by other researchers which have shown that rice can be a significant source of dietary exposure to this toxin. Rice is among the plants that take up arsenic from the soil, which can be problematic if grown in areas awhere arsenical pesticides were used.

“In the absence of regulations for levels of arsenic in food, I would certainly advise parents who are concerned about their children’s exposure to arsenic not to feed them formula where brown rice syrup is the main ingredient,” says Brian Jackson, Ph.D., lead author of this latest study and a member of Dartmouth’s Superfund Research Program, which is funded by the National Institute of Environmental Health Sciences. He noted, however, that infant formulas containing added rice starch did not appear to be a concern in terms of elevated arsenic.

Jackson also pointed out that brown rice syrup is likely to have higher arsenic concentrations than other sweeteners whether the rice is grown organically or not. “That’s because the rice takes up natural arsenic from the soil and when the rice is used to make brown rice syrup, much of that arsenic ends up there,” he said. “We focused on organic brown rice syrup because this seems to be a sweetener of choice for some organic food products.”

Food Court will update this story when it receives a comment from the FDA. Until then read more from Consumer Reports on how to avoid potential arsenic in the food supply.

***UPDATE: Read the FDA’s response to Food Court.***

The New York Times is reporting of another incident where EU approval was followed by a recall and phase out of the device. Barry Meier writes in the Times about an artificial hip implant from Johnson & Johnson that the company marketed in Europe and elsewhere overseas after the US FDA rejected its sale in the United States based on a review of company safety studies. Meier notes that J&J continued to sell a related model in the US during that same period, which earlier went on the market using a regulatory loophole (a modification of a predicate device) that did not require a similar safety review of clinical data.

During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.

The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an Articular Surface Replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.

The Times reports that the FDA expressed doubt about the safety and effectiveness of the device to J&J in 2009. In a confidential letter, the F.D.A. told Johnson & Johnson that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times. The Agency also told the company it would need added clinical data to pursue the application, a process that would probably have taken a year or more. DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.

The Times is careful to note that J&J did not break the law, merely cleverly navigate the regulatory waters. There is no requirement for a company to report FDA refusal to a EU Notified Body. Although easier to gain approval in EU (at least for the current moment) there are hidden costs to pursuing a CE mark before FDA approval. These include the cost of a recall, damage to the brand from a product problem, and potential loss of a device design due to a high failure rate. Striking the balance between arriving first-to-market with the latest technology must be balanced by the best assurance that the device is safe. A CE mark should be a strategic choice, not one of convenience.

From the FDA:

The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.

In addition to recommending new user fees to support the review of generic drugs and biosimilars, the FDA budget also contains increased funding for priorities such as import safety, medical countermeasures and research facilities to protect patients and consumers.

“These are austere budget times, and the FDA budget request reflects this reality,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “Our budget increases are targeted to strategic areas that will help speed the availability of new medical products, address the challenges of increased globalization and allow FDA to fulfill its public health duties more efficiently. With FDA-regulated products accounting for about a quarter of each dollar that Americans spend, these budget priorities will benefit patients and consumers and strengthen our economy.”

Highlights of the FDA FY 2013 budget include:

• Protecting Patients Initiative (+$364 million) recommends new user fees to support FDA generic drug activities and to support development and review of biosimilar biological products. Biosimilar biological products are highly similar to biological products that are already approved for marketing in the U.S. FDA’s budget request for these user fees is consistent with the agreement reached with industry. The initiative also includes resources to equip state-of-the-art laboratory facilities on FDA’s White Oak, Maryland campus for research to protect patients and consumers.
• Transforming Food Safety Initiative (+$253 million) will bolster FDA’s efforts to build a strong, reliable food safety system – as envisioned in the landmark Food Safety Modernization Act (FSMA). With the support of new user fees, FDA will foster a prevention-focused domestic and import food safety system to protect the health of American consumers. Under this initiative, FDA is also proposing new user fees to support its cosmetic and food contact substance programs.
• Food and Drug Inspections in China: The Transforming Food Safety and Protecting Patients Initiatives include $10 million in new resources for FDA to enhance collaboration with our Chinese counterparts and increase the agency’s presence in and expertise on China. This investment will strengthen the safety of the food and drugs produced in China for export to the United States.
• Medical Countermeasures (MCM) Initiative (+$3.5 million) will help meet America’s national security and public health requirements for MCM readiness. Congress provided new resources in FY 2012 to support FDA’s role in protecting the United States from chemical, biological, radiological and nuclear threats, and from emerging infectious diseases such as pandemic influenza. The additional resources in FY 2013 will support science and partnerships to improve MCM development timelines and the success rates for MCMs. FDA will also expand technical assistance to developers, focusing on the highest priority MCMs.
• Data Consolidation and IT Savings (-$20 million) initiative will produce savings to meet the requirements of recent executive orders that promote government efficiency and assure environmental, energy and economic performance. FDA will also reduce redundant computer equipment and achieve other IT savings.

For more information:

The President’s FY 2013 budget for the FDA

This is perhaps the most common error made by product manufacturers and distributors. The definition of a medical device is intentionally broad and requires careful evaluation prior to the marketing and sale of a product that may be classified as a medical device. The FDA is notably monitoring and shutting down production of unapproved devices (read more).

Under the terms of the consent decree, Accurate Set must discontinue its operations until the FDA clears or approves its products, which include a variety of restorative dental products such as dental impression and repair materials. In addition, any future manufacturing must fully comply with the FDA’s quality standards.

“The FDA has very clear requirements for the clearance, approval, and production of medical devices,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

The FDA’s most recent inspection of Accurate Set, between December 2010 and January 2011, revealed significant violations of the FDA’s Quality System (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits. The QS regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices.

Investigators also found that medical devices made by the company, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.

Accurate Set and Adams have represented that they are no longer manufacturing or distributing any devices. If they decide to resume operations, they first must obtain FDA approval or clearance for their medical devices. The consent decree also requires them to comply with the QS regulation for all their devices and to retain an independent expert to inspect their operations and certify to the FDA that the necessary corrections have been made.

“This consent decree demonstrates the FDA’s commitment to protecting the public health from the dangers of unapproved and improperly manufactured medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs.

In the event of future violations, the FDA may order Accurate Set and Adams to stop manufacturing and distributing medical devices and to recall those already on the market. The FDA can take other actions to ensure that they comply with FDA regulations, and may require Accurate Set and Adams to pay damages if they fail to satisfy the decree’s provisions.

The consent decree was signed by Judge Susan D. Wigenton of the U.S. District Court for the District of New Jersey on February 7, 2012.

“As you know, we had already been working on a revision of the Medical Devices legislation and within the context of the ongoing preparatory work we had included provisions, among others, on the strengthened supervision of notified bodies, clinical investigations, vigilance and traceability,” said Dalli.

“All Member States, EFTA countries and Turkey, which is covered by a free trade agreement, must ensure that the requirements to be met by the independent notified bodies that are involved in the pre-market assessment of medical devices are rigorously and consistently applied,” Dalli went on to say.

According to the Commissioner, notified bodies must “make full use of the powers given to them under the current directives,” and taking clear aim at the PIP scandal said “unannounced inspections are an important component of their responsibilities.” Dalli said that the EC will be looking in to ways to coordinate these activities to prevent unnecessary duplication.

Dalli also called for an improved medical device vigilance system and a medical device traceability system to ensure long term safety monitoring of patients and their implanted medical devices. Dalli said that Member States are “in the process of establishing systems of Unique Device Identification (UDI).”

Politico reported last week that US efforts to implement this UDI to ensure harmonization across both the US and EU have been stalled by the Office of Management and Budget since June. Dalli’s increased emphasis on this UDI system may risk a divergence in standards if the EU is pressured to release guidelines before the US releases its guidelines.

From the Associated Press:

WASHINGTON — Home-brewed coffee lovers, take note: More than a million popular coffee makers are being recalled after dozens of reports of the brewers spraying hot liquid, coffee grounds or tea leaves onto people.

The Consumer Product Safety Commission says there have been 140 reports of problems with the Tassimo (TAH’-sih-moh) single-cup brewers dousing people, including 37 cases involving second-degree burns.

In one incident, a 10-year-old girl was hospitalized with second-degree burns to her face and neck.

CPSC says the coffee maker’s “T-disc,” the plastic disc that holds the coffee or tea, can burst while brewing.

About 835,000 coffee makers are on recall in the United States; another 900,000 in Canada.

The agency also announced the recall of 4 million packages of Tassimo espresso T-discs after 21 reports of problems.

—