Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

FDA Explains Electronic Study Data Submission Expectations

New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format standardized study data for electronic submission.

The guidance pertains to submissions of clinical and non-clinical data related to Investigational Device Exemptions (IDEs), premarket notifications (510(k)s) and premarket approval applications (PMAs) submitted to the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research and other medical device and pharmaceutical review divisions of the FDA.

Planning and Provision of Standardized Data
First, study sponsors should include descriptions of their standardized study submission plans in their IDEs. These plans must also be included in the Data Management Plan sections of sponsors’ IDE study protocols, and lay out which data standards sponsors intend to use. (Any studies that will not be standardized should also be described, along with explanations for using non-standardized studies.)

Controlled Terminologies
Second, the guidance recommends that study sponsors utilize terminology standards such as CDRH Event Problem Codes as part of their standardized electronic submission efforts. This makes FDA analysis of study data more efficient. The FDA Study Data Standards Resources Web Page lists all terminology standards currently accepted by agency divisions.

Standardization of Previously Collected Nonstandard Data
In cases where study data elements cannot be readily converted to standardized formats, sponsors should document why such data could not be fully standardized. In addition, sponsors should identify which studies contain nonstandard data that were converted to standard formats.

Data Validation
Sponsors should also conduct data validation prior to sending their submissions to the FDA. The agency recognizes two major validation rules: technical validation rules to ensure data submitted conforms to standards, and business validation rules to ensure that data will support relevant business processes as intended.

FDA Meetings
Finally, the guidance recommends using FDA-sponsor meetings such as pre-IDE meetings to point out any outstanding study data standardization issues. In addition, sponsors and manufacturers can send technical questions at any time to CDRH and/or CBER technical support teams.

Markets: USATags: 510(k), 510k, clinical study, FDA, IDE, investigational device exemption, medical device, PMA

Author: Stewart EisenhartDate: February 22, 2012

Tighter EU Regulatory Controls Proposed following PIP Controversy

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.

Markets: EuropeTags: EC, EU, european commission, European Union, MDD, medical device, Medical Device Directives, Medical Devices Directive, PIP

Author: Stewart EisenhartDate: February 13, 2012

New FDA Informed Consent Rules Set for March 2012 Implementation

New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012.

The rules will require some clinical trial sponsors and investigators to include statements in their Informed Consent documents that clinical trial data will be entered into a database available via the website www.clinicaltrials.gov. Applicable clinical trials falling under the scope of the new rule include controlled intervention studies of device subject to FDA regulation, studies involving devices manufactured in the US, or studies conducted under Investigational Device Exemptions (IDE).

The onus is on sponsors and investigators to determine whether their clinical trials must comply with the new rules. Applicable clinical trials initiated on or after March 7, 2012 must comply with these requirements.

According to 21 CFR 50.25(c), Informed Consent documents for clinical trials falling under the new rule must include the following statement verbatim:

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Medical device clinical trials specifically excluded from the new Informed Consent rules include small feasibility trials as well as trials for prototype devices with primary measures of feasibility.

Markets: USATags: clinical trial, FDA, informed consent, medical device

Author: Stewart EisenhartDate: February 11, 2012

FDA Guidance Tackles Off-Label Information Requests in the Digital Age

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.