Worldwide Medical Device Regulatory Updates

The US Food and Drug Administration is planning new premarket notification requirements for manufacturers of X-ray imaging systems used on pediatric patients.

New agency guidance argues that the general indications for use most X-ray devices currently provide on the US market do not address particular concerns regarding higher sensitivity of pediatric patients to effects of radiation emitted by these devices. If enacted into law, the new guidance could impact not only 510(k) submission requirements, but also device design issues and labeling for manufacturers whose products fall under the new proposal.

According to the guidance, manufacturers seeking 510(k) clearance for new X-ray imaging devices must either provide additional data to support safety and effectiveness in pediatric populations, or provide warning labels for their products if they intend only to target adult populations following FDA clearance.

Information that new rules would require manufacturers to include in their 510(k) premarket notification applications include clear definitions of indications for use for pediatric patients; device descriptions explaining device design features for pediatric patients; and risk assessment data that includes risks specific to pediatric populations.

Pediatric-appropriate protocols, laboratory image quality and dose assessments, and clinical image quality assessments pertaining to pediatric populations should also be included.

The FDA is accepting public comment on the guidance over the next 120 days.

The Global Harmonization Task Force (GHTF) has proposed establishing a standardized grading system for quality management system (QMS) nonconformities, along with a standardized Regulatory Audit Information Exchange Form to provide more consistent ISO 13485:2003 audit data for use between medical device market regulators.

The GHTF’s proposed Regulatory Audit Information Exchange Form includes three parts. First, a list of nonconformities from a QMS audit report is necessary to explain each nonconformity reported. (The nonconformities included in this list should match those listed in the manufacturer’s original audit report.)

Second, details of a Nonconformity Grading System should be included showing how the manufacturer’s final nonconformity grade was determined.

Third, nonconformities pertaining to country-specific medical device regulatory requirements outside the scope of ISO 13485 should be identified in order to provide regulators with a more complete picture of a particular manager’s general state of compliance.

The GHTF’s proposed Nonconformity Grading System entails a two-step approach: Step 1, involving a Nonconformity Classification Matrix to make initial evaluations, and Step 2, which applies escalation rules in order to determine a final grade.

“Currently, the significance of a nonconformity related to a medical device manufacturer’s Quality Management System (QMS) may vary between regulatory authorities and auditing organizations,” the GHTF proposal states. “All parties will benefit through the use of a standardized and transparent grading system of QMS nonconformities to communicate the findings of a regulatory audit, building the confidence necessary for the potential mutual acceptance of the results of a regulatory audit.”

Even though no current standard QMS regulation exists across medical device markets—even among the GHTF founding members, ISO 13485 is not uniformly required—establishing a single method for evaluating quality system nonconformities could lead to a more effective global regulatory approach to medical device quality systems.

In a move likely to boost interest in the Singaporean medical device market, the Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to implement new rules effective May 1 to provide expedited market access for lower-risk devices.

First, the rules will exempt all Class A medical devices (with the exception of sterile Class A products) from HSA registration requirements. Manufacturers of qualifying devices must still declare their products in their importer and manufacturer licenses, and update their lists of qualifying devices every six months to enable post-market surveillance efforts. Sterile Class A device registrations will have target timelines of 30 days, and fees for these registrations will remain at $25. The HSA estimates that 80% of all Class A devices will qualify for the new registration exemption.

Effective September 1, 2012, the HSA will also establish Immediate and Expedited Registration routes for some Class B devices.

• Immediate Registration Route: allows immediate access to the Singaporean market for Class B devices already approved by at least two independent reference regulatory agencies (US FDA, EU, Health Canada, Therapeutic Goods Administration and/or Japan’s MHLW) and marketed for at least three years with no safety issues
• Expedited Registration Route: 60-day registration periods will be available for Class B devices that have either been approved by at least two independent reference regulatory agencies or approved by one such agency and have been marketed either in Singapore or that agency’s jurisdiction for three years without any safety issues

Second, Singaporean regulators plan to implement a lower-tiered fee structure for Special Authorization Route (SAR) devices starting August 1, 2012. The SAR is designed for innovative, low-cost and low-volume devices. The HSA will temporarily offset SAR fees for all applicants subject to pending registration or change notification that have submitted their applications by December 31, 2012. In addition, eligible SAR applications that have not been approved by the HSA as of April 20, 2012 will be issued refunds.

Health Canada has announced changes to its list of recognized list of medical device standards used to demonstrate safety, effectiveness and labeling requirements of the Canadian Medical Devices Regulations in order to foster more efficient device reviews.

The changes to the Therapeutic Products Directorate’s List of Recognized Standards for medical devices have specifically been altered as follows:

• 28 new standards will be added to the List
• 10 new editions of currently recognized standards will replace previous editions
• One standard will be deleted from the List
• Two standards will be superseded

These changes are part of Health Canada’s ongoing effort to ensure standards it requires licensed medical device manufacturers to follow are up to date.