Blog – Page 13 – ComplianceAcuity

FDA to implement or reach a major milestone this year (2011) for forty-two of its prior fifty-five 510(k)-process recommendations

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January 2011

In August 2010, FDA released for public comment a two-volume set of documents entitled “[CDRH] Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled “510(k) Working Group Preliminary Report and Recommendations.” Volume II is entitled “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”

In the two volumes, the Working Group and the Task Force made fifty-five recommendations aimed at improving the 510(k) process, which is the most common path to market for medical devices. After considering public comments received, FDA unveiled on January 19, 2011, a detailed report describing its game plan for addressing the fifty-five recommendations.

Here’s a recap of the plan:

• Twenty-eight of the recommendations received overall support from public comments. Accordingly, FDA intends to promptly implement or reach a major milestone for these by the end of this calendar year 2011.

• Twelve of the recommendations received support with a caveat or modification. Accordingly, FDA intends to promptly implement or reach a major milestone for these by the end of this calendar year 2011, taking the caveats and modifications into consideration.

• Fifteen of the recommendations were the subject of “significant concerns” raised during the now-closed public comment period. For two of the fifteen, FDA intends to promptly implement or reach a major milestone by the end of this year 2011. Seven of the fifteen will be further reviewed by the nonprofit Institute of Medicine (IOM), whose feedback will be considered by the FDA in order to devise appropriate action items later. Four of the fifteen will be addressed later via device-specific guidance on a case-by-case basis. The final two of the fifteen will be addressed later after additional stakeholder feedback is obtained via public meetings.

In total, 42 of the original 55 recommendations will be implemented or have major milestones this calendar year 2011. Interestingly, the FDA work-plan for doing this has been distilled and presented as only 25 action items in FDA’s 2011 action plan summary. Therefore readers are urged to be aware of the fact that 42 of the 55 recommendations are indeed represented in the 2011 campaign, not just 25 as could easily be concluded upon first glance at the action plan and FDA’s corresponding press release.

During the 2011 portion of the campaign, FDA is focusing on the actions that will have the greatest impact on the original goal of the 2010 recommendations (i.e., fostering medical device innovation, enhancing regulatory predictability, and improving patient safety). Key examples include streamlining the de novo process, issuing guidance to provide greater clarity about the 510(k) program, improving training for CDRH staff and industry, making greater use of external experts, and making critical business process improvements in CDRH, such as establishing a Center Science Council.

Health Canada authorizes e-labeling for certain medical devices not sold to the general public

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November 2010

On November 9, Health Canada’s Therapeutic Products Directorate (TPD) issued a permissive notice immediately authorizing device manufacturers of certain categories of devices to provide, in electronic format instead of paper format, the information ordinarily found in the directions for use pursuant to Section 21(1)(i) of the Canadian Medical Devices Regulations.

The permissive notice applies only to medical devices NOT SOLD TO THE GENERAL PUBLIC. This means devices only sold to, and intended for use by, a healthcare professional; and devices that are in vitro diagnostic devices (IVDD’s) that are NOT “near patient” IVDD’s.

The permitted e-labeling formats are Compact Disk (CD) or Digital Video Disk (DVD). The CD/DVD should be easily navigable, must be clearly labeled as to its purpose, and is to accompany the device at the time of sale or delivery.

TPD has also provided an additional e-labeling alternative for two subcategories of devices not sold to the general public: Class IV devices and IVDD’s that are NOT “near patient” IVDD’s. For these subcategories, the directions for use may alternatively be provided in downloadable format from the internet assuming certain conditions are met.

The Letter of Attestation modeled in the TPD Notice is to be completed and filed in the Manufacturer’s Quality Management System, and made available for review upon request by Health Canada, a CMDCAS Registrar, or a customer.

Directions for use submitted with Medical Device License Applications must still be submitted in paper format.

Click here for a link to the permissive Notice.

Health Canada gaining ground, but still backlogged in device license application processing

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October 2010

In its September 7 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau is still wrestling with a significant increase in the volume and complexity of device license applications during the last 12-18 months.

As the Bureau grapples with the influx, the processing of Class III and IV non-IVDD device applications are taking approximately 30-days longer than the Bureau’s post-screening 60-day (class III) and 75-day (class IV) review targets in the Cardiovascular and Musculoskeletal device license evaluation Sections. The General & Restorative Section is 3 weeks behind schedule. Applications for IVDD’s are taking 1-2 weeks longer than review targets.

ComplianceAcuity has also learned that class II device license applications are taking approximately three and a half weeks (versus the Bureau’s 15-day policy target). Fax-back amendments are on schedule.

Industry has until October 4th to comment on FDA’s 510(k) recommendations released July 30th

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August 2010

The Food and Drug Administration’s (FDA’s) premarket notification (510(k)) process for the review of medical devices was established in 1976 and provides a more abbreviated mechanism of medical device premarket clearance than FDA’s Premarket Approval (PMA) process. As indicated by FDA, the 510(k) program, as it currently exists, aims to support FDA’s public health mission by meeting two important goals: making safe and effective medical devices available to consumers, and fostering innovation in the medical device industry. But in recent years, concerns have been raised within and outside of FDA about whether the current 510(k) program optimally achieves these goals.

In response, the FDA announced July 30th the availability for public comment of a two-volume set of documents entitled “Center for Devices and Radiological Health Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled “510(k) Working Group Preliminary Report and Recommendations.” Volume II is entitled “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations.”

Although some in industry have rushed to conclude that the FDA recommendations represent official changes to the 510(k) process, it is noteworthy to mention that the recommendations contained in the FDA reports are preliminary, and FDA has not made any final decisions on specific changes to pursue. The program hasn’t yet been officially revamped, and no final rulemaking has taken place in the Federal Register.

Industry has been invited by FDA to comment, and to propose other recommendations and/or alternatives. But there is a relatively short window of opportunity in which to do so: only until October 4. Instructions for submitting comments can be seen in the corresponding Federal Register notice.

Health Canada decides to delay full STED implementation until July 1, 2011 for non-in vitro diagnostic Class III and IV Medical Devices

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June 2010

As ComplianceAcuity previously reported in August 2009, Health Canada’s Medical Devices Bureau issued a notice proposing to fully implement the use of the GHTF STED format for Class III and IV premarket Medical Device License Applications by July 1, 2010.

On June 17th, Health Canada announced that the full STED implementation will be delayed for an extra year, until July 1, 2011, to allow for additional work and industry feedback on the Medical Devices Bureau’s new guidance document outlining Canadian regulatory submission requirements for Class III and IV medical device license applications submitted using the STED format. The new guidance document will replace the current guidance document entitled “Guidance for Manufacturers Preparing a Premarket Application Using the Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices”.

In the interim, the Bureau will continue to accept Class III and IV premarket review documents in the usual format, as well as class III and IV non-in vitro diagnostic device applications submitted using the STED format voluntarily under the Bureau’s January 1, 2001 pilot program and corresponding fact sheet. On that note, although originally intended to run for only one year and to apply to only a specific subset of devices, the Bureau’s Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau) confirmed to DeviceWise that the pilot program has been extended indefinitely, and that it may now be used for all class III and IV non-in vitro diagnostic devices. Ms. Chandler also emphasized that the Bureau is encouraging the voluntary use of the STED format instead of the usual format.

Health Canada backlogged in processing of device license applications

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February 2010

In its February 25 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau has seen a significant increase in the volume and complexity of device license applications during the last 12-18 months.

As the Bureau grapples with the influx, the processing of Class III and IV non-IVDD device applications are taking approximately 60-days longer than the Bureau’s post-screening 60-day (class III) and 75-day (class IV) review targets in the Musculoskeletal and the General & Restorative device license evaluation Sections. The Cardiovascular Section has experienced similar backlogs recently, however is “on target” at the moment. Applications for IVDD’s are taking 6-8 months.

ComplianceAcuity has also learned that class II device license applications are taking approximately three weeks (versus the Bureau’s 15-day policy target). Fax-back amendments are on schedule.

FDA releases its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistics

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February 2010

On February 5, FDA released its final guidance document on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods. Bayesian statistics is an approach for learning from evidence as it accumulates.

In clinical trials, traditional (frequentist) statistical methods may use information from previous studies only at the design stage. Then, at the data analysis stage, the information from these studies is considered as a complement to, but not part of, the formal analysis. The Bayesian idea is to consider the prior information and the trial results as part of a continual data stream, in which inferences are being updated each time new data become available.

Health Canada requests electronic filing of some device license applications

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January 2010

Effective January 1, 2010, all Class IV medical device license applications should be submitted in both a paper and electronic format and be prepared using the specifications outlined in the December 14, 2009 guidance document “Preparation of a Premarket Review Document in Electronic Format for a Class IV Medical Device License Application”.

ComplianceAcuity complaint handling solution featured by F-D-C Reports

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January 2010

The ComplianceAcuity complaint handling solution was featured by F-D-C Reports in “The Silver Sheet” in September 2006 after the process was implemented at a large international device manufacturer during a global quality system remediation campaign spurned by an FDA warning letter.

Health Canada intends to adopt GHTF Summary Technical Documentation (STED) format for class III and IV device applications

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August 2009

The Therapeutic Products Directorate (TPD), Health Canada has announced that it intends to adopt the Global Harmonization Task Force’s STED guidance document published February 21, 2008 to encourage and support the global convergence of documentation requirements for medical devices. Adoption of the STED as a basis for demonstrating conformity to the Essential Principles of Safety and Performance of Medical Devices (or ‘Essential Principles’) will most likely occur by way of a phased-in approach. Once fully implemented (July 1, 2010), manufacturers would be expected to submit Canadian premarket applications for Class III and IV medical devices based on the STED guidance document.

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