FDA Cedes to Industry, Extends UDI Deadline on Some Implants

The FDA is giving manufacturers of some orthopedic implants an extra two years to put unique device identifiers on their products.

The decision, announced in a letter to industry, extends the UDI compliance date to Sept. 24, 2016, for more than four dozen single-use orthopaedic implants that are sterilized before use. Items on the list include dental implants, metal surgical mesh, surgical wire, and bone staples, plates and nails. The original deadline for complying with UDI requirements was Sept. 24, 2014, for Class III implants and Sept. 24, 2015, for Class II implants.

Under the UDI final rule, devices must display a unique identifier on its packaging at all times so that the information can be entered into electronic health records. It does not require direct marking on the product. However, the surgical implants listed in the letter are typically separated from their original packaging for sterilization well before use, the FDA notes.

The agency says AdvaMed has proposed potential solutions to allow these devices to be adequately identified, but that manufacturers need extra time to thoroughly develop and validate them. “FDA is initiating this extension to allow time for the development and implementation of an alternative that would provide for more accurate and precise device identification,” the letter says.

Companies will still need to add their products to the Global Unique Device Identification Database by the original deadlines.

Tara Federici, associate vice president of technology and regulatory affairs at AdvaMed, commended the FDA’s decision, saying the extension will allow manufacturers for a small subset of products to develop approaches that satisfy the goals of the UDI rule.

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FDA Beefing Up Inspections Presence in China

The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S.

In 2013, CDER and CBER combined inspected only 62 Chinese facilities.  And so far in 2014, the agency has issued just four warning letters to Chinese manufacturers.

The FDA’s staffing announcement comes on the heels of Commissioner Margaret Hamburg’s five-day trip to China where she signed an Implementing Arrangement with the China FDA, aimed at improving coordination between the agencies on drug quality issues. She said the FDA expects to sign a similar Implementing Arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in the coming weeks.

The agreements expand on previous cooperation between the two countries, including a 2007 pact in which China agreed to begin certifying that exported drugs meet agency standards and that it would notify the FDA within 24 hours when it discovered a problem that represents a significant public health concern.

The staffing increase is long overdue, having first been authorized in 2011, Michael Burke, a partner at law firm Arnall Golden Gregory, said. The issue has been complicated by a delay by the Chinese government on issuing visas for new personnel, he added.

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EMA Urges Assessment of Cross-Contamination Risks During Manufacture of Drugs

Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline.

The European Medicines Agency recommended ways to determine threshold levels of pharmacological and toxicological values that may be present in shared facilities. The formula for determining the permitted daily exposure (PDE) amount is based on a product’s hazards, critical effects and no-observed-adverse-effect levels, as well as uncertainties, the guidance said.

A PDE is a substance-specific dose that is unlikely to case an adverse effect if an individual is exposed to this dose every day for a lifetime.

Risks should be considered on a cause-by-case basis, the agency said. Determination of health-based exposure limits may not be necessary for protein-based products because they can be degraded or inactivated by cleaning equipment with pH extremes and/or heat.

Furthermore, active substances and products must be made in dedicated facilities if scientific data does not support an acceptable level of exposure or handling risks can’t be adequately controlled.
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FDA: Meeting, Audit Needed After Inspection of Dx Maker

The FDA has requested a meeting with Express Diagnostics International, as well as an independent audit of the company’s manufacturing practices, following an inspection that uncovered problems with testing and labeling of the company’s products.

Officials from the Blue Earth, Minn., company, which makes drug abuse test kits, were asked to visit the FDA’s Minneapolis office to discuss the inspection, corrective and preventive actions related to a complaint of false positive results and practices regarding “forensic use only” labeling. “In particular, we are concerned about whether your products have the required premarket clearances for the manner in which they are being promoted and distributed,” the agency said in a Sept. 17 warning letter, recently released.

The FDA also has requested an audit and certification by an outside consultant by Dec. 12, with subsequent certifications of updated audits and corrections over the next two years. The agency will conduct a follow-up inspection to verify that Express Diagnostics has followed through on corrective actions.

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