FDA announces availability of e-submission process for requesting CDRH export certificates…

January 2013
On January 22, FDA announced via Federal Register the availability of an electronic submission process for requesting export certificates for products regulated by FDA’s Center for Devices and Radiological Health (CDRH). The e-process is aimed to help meet certain requirements set out by the FDA Export Reform and Enhancement Act of 1996 and other FDA requirements.

Has FDA recently rejected your medical device submission e-copy?

January 2013

If you’ve had your FDA medical device submission e-copy rejected recently by FDA, you’re probably not alone. When firms submit the mandatory e-copy of their medical device submissions, FDA now requires the e-copy to conform to a mind-boggling array of specifications. Here are links to FDA’s corresponding Federal Register announcement and guidance document.

CDRH Accepts Web-based applications for Certificates to Foreign Government

November 2012

CDRH is now accepting web-based applications for Certificates to Foreign Government. The web-based applications are to be submitted electronically through the CDRH Export Certification Application and Tracking System (CECATS). CDRH purports that use of CECATS for CFG applications will offer several benefits, including a reduction in certificate processing time (CFG’s are projected to be issued within 20 business days), real-time validation and status updates.

FDA publishes a revised UDI proposed rule

November 2012

On November 19, 2012, FDA published a revised UDI proposed rule to accommodate the enactment of FDASIA, which was signed into law (Pub. L. 112–144) on July 9, 2012. Specifically, pursuant to FDASIA, the purpose of the revised UDI proposed rule is to specify the date by which a proposed rule is required, to identify particular devices as requiring expedited implementation of UDI requirements, and to specify timeframes for publication of a final rule.

Wondering how FDA’s UDI rule might affect labelers? Here’s a non-exhaustive summary

July 2012

• This is a “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week.

• Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage.

• All devices [201(h) of the Act] will require UDI except:

– Those for purchase at retail (except prescription devices)

– Class 1 GMP-exempt

– Certain single-use class 1 devices not intended for individual sale

– Devices solely for research, teaching, or chemical analysis

– Custom, investigational, veterinary, and export-only devices

– Strategic Nat’l Stockpile devices

– Certain sec. 514 performance-standard devices

– Combination-product device-constituents that can’t be used apart from the combination

– Single-use members of convenience kits

• Class 1, 2, and 3 devices must comply by 5 years, 3 yrs, or 1 yr, respectively, after UDI final rulemaking (exception noted below).

• Shipping containers don’t need to display UDI.

• UDI’s must appear on the label and “package” (per UDI-rule definition).

• UDI’s shall have two parts: 1) Device Identifier [mandatory, fixed part identifying the labeler and the “version/ model” (special definition)]; and 2) Production Identifier (variable part for lot, expiry, etc.) when such variables are included on the label.

• Class 1 device UDI’s don’t require a Production Identifier.

• Each UDI must have a plain-text form AND a form based on AIDC technology. If the AIDC form is not conspicuous, then the label must display a special symbol.

• 2 years after the aforementioned phase-in dates, and within certain parameters, the UDI must also permanently appear DIRECTLY ON devices that are a) implantable; b) reusable and must be sterilized before each use; or c) stand-alone software.

• Each device “version/model” must bear a unique UDI. This is driven, among other things, by the fixed quantity of devices in a “package”.

• As currently worded, the proposed rule prohibits labelers from autonomously generating UDI (which may be unique for each unit or lot). Instead, EVERY UDI shall be issued by the FDA, or an FDA-accredited agency. This could have a significant operational impact on labelers, so I encourage readers to think carefully about this during the 120-day comment period.

• Dates on labels must now conform to the following format (today’s date for example): JUL 6, 2012

• UDI format must meet the criteria defined, as applicable, by a) ISO/IEC 646:1991; b) ISO/IEC 15459-2:2006(E); c) ISO/IEC 15459-4:2008; and d) ISO/IEC 15459-6:2007.

• Using various procedures, labelers must submit certain UDI data to FDA for posting in FDA’s online public “GUDID” (Global Unique Device Identification Database).

• GMP: The UDI shall be recorded on device history, complaint, and service records. Label inspection/release shall verify the correct UDI on labels.

• MDR’s & part 806 reports shall reflect the UDI of the subject device.

• Market-status updates in PMA periodic reports shall include UDI Device Identifiers (certain legacies excluded).

• Other UDI topics addressed by the rule include those related, but not limited to, combination products, convenience kits, voluntary UDI, change control, discontinuation of NHRIC and NDC numbers, and others.

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

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

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

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.