Medical Device Blog – QA & Regulatory Updates from Emergo Group

European Union member states should take immediate steps to tighten regulatory controls over medical devices and technologies in the wake of revelations that French breast implant manufacturer Poly Implant Prothèse Company (PIP) used non-medical-grade silicone in its products.

European Health and Consumer Policy Commissioner John Dalli last week urged coordinated efforts at national levels to ensure full implementation and enforcement of existing medical device legislation to guarantee safety and improve patient confidence in the EU regulatory system.

Dalli’s specific recommendations include verification of notified body designations to evaluate whether these entities are truly designated only for assessment of medical devices and technologies, as well as making sure that Notified Bodies fully leverage their authority laid out in conformity assessments, including their power to conduct unannounced inspections.

Dalli also recommends reinforcing market surveillance processes by national regulators, especially regarding spot checks of some devices. Vigilance system functions must also be improved via granting Notified Bodies systemic access to adverse event reports and urging health care providers and patients to report adverse events to authorities.

In addition, Dalli suggests supporting development of tools to enhance traceability of medical devices in the EU, and tools such as the Unique Device Identification system for monitoring long-term safety and performance of devices.

Finally, results of a stress test being conducted to address any weaknesses in the EU system illustrated by the PIP incident will impact ongoing work to revise the EU’s Medical Devices legislation, according to the European Commission’s press release.

European medical device industry trade association Eucomed has officially expressed support for Dalli’s recommendations, and has added a few of its own as well: utilizing “only the best” Notified Bodies, developing a single approach to vigilance and market surveillance, and strengthening harmonized standards used in the EU. Furthermore, Eucomed recommends more consistent guideline implementation, added transparency and a more integrated regulatory approach.

Whether the PIP controversy significantly impacts how Europe’s Medical Device Directives are revised remains to be seen. Reactions among member states so far do not bode necessarily well for a more unified approach, however; French authorities, for example, have initially taken a much more aggressive approach to the problem than their British counterparts. 

Guidance published by the FDA in late 2011 intends to update regulatory requirements for medical device manufacturers responding to public and non-public requests for off-label information about their products.

Now that online forums, email, social networking sites and other more advanced communication methods have become more widely used, the FDA has revised its approach to off-label information requests to take into account these new electronic communication methods.

The guidance reiterates the agency’s longstanding policy that a manufacturer’s responding to unsolicited requests for off-label information in such a way that suggests an unapproved intended use for the device in question is prohibited.

Public requests for off-label information
The FDA distinguishes between public unsolicited requests for off-label information—those made in public forums and directed either to an individual firm or to a wider forum—and non-public requests, which are directed privately to individual firms using one-on-one communication methods.

The guidance includes electronic communications under the public request category; consumers more often conduct online research on medical products and technologies, and off-label use questions from consumers are often seen by other online consumers as well as firms. Concerned that manufacturers may respond to individual requests for off-label data via online, public methods—particularly if those responses include intended use information that does not square with FDA approval—the agency recommends responding privately to any public request for such information. In the event that a firm opts to respond publicly, however, the FDA guidance provides the following suggestions:

• A firm should only reply to online public unsolicited off-label information requests in terms of specific information regarding its own products—not competitors’ products
• A firm’s public  response to an information request should only consist of the firm’s contact details, not any off-label data
• Any representatives of manufacturers responding publicly to questions regarding off-label information should fully disclose their relationship to those manufacturers
• Public responses to such requests should not promote or market the device or manufacturer in question

Compliance issues
Medical device industry participants have until March to submit comments on the FDA guidance. Assuming the guidance is implemented, what will manufacturers need to do in order to comply? An analysis by MDDI suggests firms revise standard operating procedures and policies regarding electronic communications, as well as potentially rope in regulatory affairs departments for any online and social media campaigns that could result in unsolicited off-label information requests—and FDA scrutiny. 

Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical devices registered in the US or Canada to some devices approved or certified for sale in Japan.

COFEPRIS equivalence will apply to devices classified as Class II, III or IV in Japan; products registered as Class I devices in Japan must still go through the standard registration process in Mexico.

Manufacturers of qualifying devices must have either approval issued by Japan’s Ministry of Health, Labor and Welfare (MHLW) or their certificates issued by a Registered Certification Body in Japan.

Some of the documents that manufacturers must also provide in order to qualify for expedited review in Mexico are:

• Operating license
• Notification of Exportation
• Original Certificate of Free Sale
• Original Letter of Representation
• Labels and Instructions for Use

The expanded Equivalency Agreement will go into effect February 24, 2012. Interest in the Mexican market has already increased over the past year due to expedited review options for manufacturers registered in the US and Canada; similar interest from medical device companies registered in Japan will no doubt also grow once the new agreement is implemented.

The Obama Administration has announced plans to require medical device and pharmaceutical companies to report payments they make to US doctor and other health care providers for research, consulting and travel.

According to a recent New York Times report (tiered subscription required), the new rules are designed to tackle influence these payments have on doctors’ treatment decisions; payment from a medical device manufacturer to a doctor has the potential to make it likelier that that doctor will prescribe that manufacturer’s device instead of cheaper alternatives, evidence suggests.

The new rules will require companies with at least one product covered by Medicare or Medicaid to disclose all payments to doctors who are not their own employees. Payment data they provide will be published online.

Types of payments falling under these requirements include compensation for development, assessment or promotion of new products as well as royalty payments to inventors, payments to teaching hospitals for research and even “$25 worth of bagels and coffee to a doctor’s office for a meeting.” Companies’ chief executives, chief financial officers and/or chief compliance officers must attest to each report’s accuracy.

Administration officials believe more than 1,100 firms will be impacted by the new rules; failure to comply will incur penalties of up to $10,000 for each payment a firm fails to disclose. Knowingly failing to report payments will incur penalties of up to $100,000 per violation, capped at $1 million per year.

The Centers for Medicare & Medicaid Services (CMS) is accepting public comment on the rules through February 17^th, after which final rules will be implemented.