Wednesday, February 16, 2011

FDA to reclassify Medical Device Data Systems

The FDA has published a final rule to reclassify Medical Device Data Systems (MDDS) from Class III devices requiring premarket approval to Class I devices regulated under much less stringent general controls.

“An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specification, or display medical device data,” according to the rule. “An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the use (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.”

The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following:
  • Makes any modifications to the MDDS that are outside the parameters of the original manufacturer’s specifications for the device, for purposes of the user’s clinical practice or otherwise for commercial distribution.
  • Purchases hardware or software and modifies it to transfer, store, convert or display medical device data for clinical use.
  • Develops in-house software with an intended use consistent with an MDDS.
  • Develops an in-house system, using multiple components of devices, that has an intended use consistent with an MDDS.
Other key points from the preview to the MDDS final rule include the following:
  • The rule does not apply to electronic health record (EHR), personal health record (PHR), computerized physician order entry (CPOE), e-prescribing or word processing systems. Laboratory information systems and picture archiving and communication systems (PACS) are not medical device data systems either.
  • An MDDS can covert data to the HTML; PDF; or Health Level Seven International, or HL7, data formats. However, “an MDDS may not otherwise convert, alter, modify or interpret the data that is received from a medical device,” the FDA said.
  • Devices that transfer information for the purpose of information exchange, or that can generate or manipulate data on their own, are not considered medical device data systems.
  • Such devices as glucose monitors, blood pressure cuffs and active patient monitors are not MDDS. These are Class III devices because they directly support and sustain a patient’s life; as such, they remain subject to stricter regulatory control, as well as to premarket approval.
  • Devices intended for use by people who are not health care professionals (data entry clerks, for example) count as MDDS, though the FDA reserves the right, “if, through normal reporting mechanisms or otherwise, FDA determines that the use of these devices by someone other than a health care professional poses an unreasonable risk of illness or injury.”

Wednesday, January 19, 2011

FDA to Revise Device Rules, but Most are Minor for Now

In a press release today, the FDA announced that it will be making 25 changes this year to its 510(k) medical device clearance program, but will hold off on any major moves until after the release of an Institute of Medicine (IOM) report scheduled for this summer.

The agency's Center for Devices and Radiological Health said it would implement changes including the streamlining of the "de novo" review process for lower-risk devices, more clarity on when medical device manufacturers must submit clinical data in a 510(k) submission, and the creation of a council to improve regulatory science.

Most of the controversial changes to the 510(k) program proposed by the agency last year were temporarily taken off the table until the release of the IOM review slated for this summer.  They include the ability to revoke 510(K) clearances, increased post-market surveillance, and the establishment of a new classification (IIb) for medical devices that would require the submission of clinical evidence.

The agency maintains that the changes (PDF) will be a boon for the process by which the vast majority of medical devices are cleared for the U.S. market, delivering "a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly," according to a statement by Shuren.

In order to facilitate innovation in medical devices, Shuren said the FDA will:
  • Streamline the review process for innovative, lower-risk products, called the "de novo" process by Sept. 30.
  • Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency on July 31.
  • Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies by Sept. 15.
  • Establish a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science-based decision making. FDA will publish the charter for the council its website on March 31. The agency plans to publish initial results of a 510(k) audit by the council on June 15.
To bolster the safety of medical devices, Shuren said the FDA will:
  • Establish a public database of important device information, such as medical device photographs, labeling and summaries of the basis for the FDA’s decision to clear specific devices. The database will be discussed at a public meeting taking place April 7 and 8.
  • Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.

Thursday, January 6, 2011

President signs food safety legislation

President Obama signed into law Tuesday legislation that represents the first major overhaul of the nation's food-safety infrastructure since 1938.

The Food Safety Modernization Act moves the FDA away from its previous role of responding to adulterated food to a more modern one of requiring companies to stop contamination before it happens by looking for the places where things can go wrong and fixing them.

The Act also allows the agency to issue mandatory recalls and hire more food-safety inspectors.

The FDA will need to draft regulations to enforce the new law.


Some of the changes the Act puts into place:

Before Now
Surveillance Under the FDA's original statute from 1938, the focus was on responding to adulterated food once it was discovered. Under the new rules, the FDA's focus shifts to stopping outbreaks before they start, by requiring farmers to address places in production where contamination might occur and to require processors to implement written food-safety plans.
Enforcement The FDA couldn't force a company to recall tainted food; it could only seek a voluntary recall. When needed, the FDA can order the recall of tainted food.
Specific targets The FDA had to treat all foods the same, despite the fact that some are more likely to become contaminated than others. FDA can develop regulations that focus on the highest-risk foods, including fruits, vegetables and imports.
Inspections The FDA was able to inspect fewer than 20% of domestic food facilities and 1% of foreign food imports. More than half of food facilities have gone five or more years without a federal inspection, according to a 2010 report from the Health and Human Services inspector general. The FDA will be able to hire 2,500 more field safety inspectors and food-safety experts by 2014 and increase substantially domestic and foreign inspections. The riskiest domestic facilities will be inspected every three years, beginning in 2015.
Records checks For most plants, when the FDA conducted an inspection, it could only require a spot check of what was happening that day. The FDA will have access to the food-safety plan, records and test results that are linked to the safety plan.
Exemptions Big and small farms and producers were treated the same under the statute. Farmers who primarily sell to farmers' markets or to restaurants, and who sell less than $500,000 a year, don't have to follow the new regulations.

Wednesday, December 15, 2010

Dannon fined for making health claims for its yogurt product

The Dannon Company will pay a $21 million fine and stop making exaggerated health claims for two very popular Dannon products under an agreement with the federal government and attorneys general from 39 states.

Dannon will stop claiming that one daily serving of Activia yogurt relieves irregularity and that its DanActive dairy drink helps people avoid catching colds or flu, the Federal Trade Commission announced on Wednesday.

"These types of misleading claims are enough to give consumers indigestion," says FTC Chairman Jon Leibowitz. "Companies like Dannon shouldn't exaggerate the strength of scientific support for their products."

The move signals a more aggressive federal watchdog roll over deceptive advertising practices by major marketers under the Obama administration
The FTC charged that Dannon's ads were deceptive because it did not have substantiation for its claims. The commission also charged that Dannon's claims that Activia and DanActive were clinically proven were false.

The FTC complaint and settlement can be downloaded from the FTC website at: http://www.ftc.gov/opa/2010/12/dannon.shtm

Here are some tips on substantiation of product claims: http://business.ftc.gov/documents/substantiation-science-compliance.

Wednesday, December 8, 2010

Court held that FDA can only regulate e-cigarettes as tobacco products

A federal appeals court ruled yesterday that the FDA can only regulate electronic cigarettes (e-cigarettes) as tobacco products and not as drug-delivery products, and therefore cannot block their import.  The ruling will allow e-cigarette maker Sottera Inc. to resume importing its NJOY products.

The FDA and other public health organizations had argued e-cigarettes should be regulated as drug-delivery devices. That would require proving that they are safe and effective as a stop-smoking aid using expensive clinical trials.

A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency's authority over tobacco.  Congress passed the Tobacco Act in 2009 to give the FDA authority to regulate tobacco products -- but not to ban them.

"The liquid nicotine in each e-cigarette is derived from natural tobacco plants."  Therefore the products are a "tobacco product" as defined by the Tobacco Act. 

However, one of the three judges on the panel appeared to be willing to reconsider this issue again if the FDA were to issue its own interpretation of "tobacco product" through the rule making process.   Also, the FDA may appeal this ruling in the Supreme Court.  In the mean time, the ruling says that the FDA can only regulate e-cigarettes as tobacco products, provided that they do not make any drug or therapeutic claims. 

The case is Sotera, Inc. v. FDA, case  no. 10-5032.  A copy of the opinion can be downloaded here.

Wednesday, November 17, 2010

FDA issues warning letters to makers of caffeinated alcoholic beverages

The FDA today issued warning letters to four companies that make caffeinated alcoholic beverages.  This came nearly a year after the agency asked 30 manufacturers to provide their rationale, and supporting data and information, for concluding that their use of caffeine in an alcoholic beverage is GRAS (generally recognized as safe) or prior sanctioned.

“FDA does not find support for the claim that the addition of caffeine to these  alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

According to the FDA, its action follows a scientific review by the Agency.  FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers.  FDA also performed its own independent laboratory analysis of these products.

Although the warning letters were sent to only four companies who did not respond to the agency's letter last year that asked for the safety data, it appears that the agency is on the path to ban all caffeinated alcoholic beverages.

Tuesday, November 2, 2010

Latest regulatory trends from RAPS conference

There were several excellent speakers at the RPAS (Regulatory Affairs Professionals Society) annual conference in San Jose last week.  They represented regulatory professionals in the private and public sectors, both domestically and abroad.  Here are some of the take-away messages from the speakers:
  • FDA is stepping up enforcement.  This shouldn't come as a surprise if you've been following the agency's enforcement actions lately.  In his speech to the food and dietary supplement industry, FDA's Chief Counsel Ralph S. Tyler stated that the agency has just began its enforcement efforts and that more are yet to come.  Among the areas of concern are the good manufacturing practices (GMP) regulations for dietary supplement products, as well as the notification requirements for new dietary ingredients.  The agency also intends to hold individual more accountable for violations, which would result in more criminal prosecutions of company executives and even employees.
  • FTC is stepping up enforcement.  Similarly, the FTC is stepping up enforcement in the area of claim substantiation.  The FTC will be looking at scientific data more closely to determine whether they support claims made about a product.   Companies should pay more attention to testimonials, because according to the government, they are never substantiated. 
  • Companies are very interested in the Chinese market, but are frustrated by the regulatory framework there.  Among the conference speakers were five officials from the Chinese State FDA (SFDA), who provided an overview of the medical device approval process in China.  This presentation was one of the popular ones at the conference, and the numbers and types of the questions asked at the end of the presentation showed many companies (large and small) are very interested in the Chinese market, and yet are frustrated with the lack of transparency in the approval process.  Here are some of the policies that can cause frustration:
    • According to a SFDA official, if a foreign company manufactures a medical device in China, the company will have to export the finished product out of China.  However, if a Chinese company puts its own label on the same product, it will be able to sell the device in China.  This policy seems to have little to do with safety and efficacy.  
    • Also according to the same official, a medical device imported into China will not receive SFDA approval if the device has not received market approval in the country of origin.  The message seemed to be: if this device is not good for your country, it's not good enough for China.
    • Questions were asked about whether the SFDA would accept data from clinical trials done outside of the China.  The answer was as clear as water - generally no, but we will decide on a case by case basis, but if we decided you need to do more clinical trials, you need to conduct them in China.  
    • Questions were asked about whether the SFDA would meet with companies to discuss their products before the companies submit their applications for approval of their products.  The answer was that the SFDA holds a "open forum" every Thursday during which anyone can participate in a Q&A session with the agency to discuss any regulatory issues.  According to the SFDA official, no appointment is required and people can participate by phone.  So much for confidentiality. 

I am still reviewing my notes and materials from the conference, and plan to blog about other interesting topics I ran across there.