Blog

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.

December 2012

Link to FDA press release.

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.

August 2012

For updates from the European Commission regarding revision of the European MDD, click the link below:

http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm

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.

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.