The Protocol Link Newsletter

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In This January 2015 Issue


 

 

 
Medical Device News You Can Use
As follows, please find a recent update from FDA to the Medical Device industry.
If you should happen to need any assistance, please contact us.
Update on UDI Implementation for Registered Medical Device Establishments (12/18/2014)
Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act), the FDA's Center for Devices and Radiological Health (CDRH) summarized recent and upcoming UDI activities and deadlines. The next two compliance dates for UDI requirements are:

* September 24, 2015 for non-Class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices
* September 24, 2016 for Class II devices

Global Unique Device Identification Database (GUDID) Data Submission
* In January 2015, FDA will begin accepting GUDID account requests from labelers of I/LS/LS devices. Later in 2015, they plan to accept GUDID account requests from labelers of class II devices. FDA strongly encourages all device labelers to take steps to ensure their readiness to meet UDI requirements well before actual data submission to GUDID. This will provide labelers with ample opportunity to assess their ability to meet requirements, including data submission to the GUDID, by their deadline and to work with FDA if they have any difficulties coming into compliance. Suggested steps are included on the UDI website.
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* Also in January, FDA will host a webinar to help Class II and I/LS/LS device labelers prepare to comply with the UDI rule. Notification of webinar specifics will be sent directly to these device labelers in early January. The webinar will include overviews of UDI requirements and how to get started with the GUDID.

UDI Policy
* FDA continues to work with industry on UDI implementation issues that surfaced in 2014, including GUDID data submission for contact lenses/IOLs and development of approaches to ensure the UDI is available at the point of use for non-sterile implants. They recognize there are several other policy issues that are of significant interest to industry; FDA hopes to address a number them in 2015, such as UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives, and issuance of additional Frequently Asked Questions (FAQs).

* The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements. Device labelers that want to retain the use of FDA-issued NHRIC or NDC labeler codes under a system for the issuance of UDIs were required to request such continued use by September 24, 2014. If you intend to retain the use of a previously issued FDA labeler code within your UDI system but have not made such a request, FDA urges you to do so as soon as possible.

UDI Adoption and Use
* FDA continues to collaborate with stakeholders, such as the Pew Charitable Trusts, the Office of the National Coordinator for Health IT (ONC), and the Brookings Institution to promote and facilitate UDI adoption in healthcare settings.

* They are working with the National Library of Medicine (NLM) to give the public search and download access to published records in the GUDID in the spring of 2015. GUDID search will allow published GUDID data to be retrieved based on parameters of interest to the user. The GUDID download function will let users download all published GUDID data at once.

Finally, FDA would like to reaffirm plans to implement this important system over several years-and underscore the fact that it fully intends to be flexible during this time. The main focus is getting the system implemented correctly and actively helping companies comply with system requirements. As with the implementation of many new systems, it can take time to understand and comply with new requirements - widespread, strict enforcement of associated deadlines and requirements is not necessarily the best way to achieve compliance at this time.

To date, industry has been very willing to work with CDRH and FDA has experienced excellent efforts and strong feedback. They urge labelers that are having difficulty fulfilling UDI requirements to let them know through the FDA UDI Help Desk.

FDA will continue to work diligently to give the medical device industry, health care systems, clinicians and patients the assistance and information needed to implement and use UDI successfully. For additional information, please see www.fda.gov/udi or contact FDA at the FDA UDI Help Desk.

Information from:
Food and Drug Administration
Center for Devices and Radiological Health

FDA Issues Two New Guidance Documents on Providing Regulatory Submissions in Electronic Format

by: Raymond Cerny 

On December 18, 2014, two new FDA Guidance Documents were finalized that have the potential to impact how you submit regulatory submissions to the FDA in the near future. The guidance documents are titled Providing Regulatory Submissions in Electronic Format-Standardized Study Data (Click here) and Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (Click here).

Section 745A(a) of the Federal Food, Drug, and Cosmetic Act, supplemented by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), requires that regulatory submissions (INDs, NDAs, ANDAs, and BLAs) be submitted in electronic format as specified by the FDA beginning no earlier than 24 months after the FDA issues a final guidance establishing the electronic format for the submission. The Guidance for Industry, entitled Providing Regulatory Submissions in Electronic Format-Standardized Study Data, is one such guidance recently finalized under these Acts. This guidance implements the electronic submission requirements of standardized clinical and nonclinical study data contained in NDAs, ANDAs, BLAs, and INDs by specifying the formatting requirements.

 

The FDA has exempted all submissions regarding "noncommercial INDs" (e.g., emergency use INDs and treatment INDs) from the requirements specified under section 745A(a). Although such submissions will be exempt, the FDA will accept their voluntary submission in a standardized electronic format as described in the relevant guidance document and Data Standards Catalog. Study data contained in electronic submissions must be in a format that the Agency can process, review, and archive as specified in the Data Standards Catalog (Click Here). 

 

The Agency may "Refuse To File" (RTF), for NDAs and BLAs, or "Refuse To Receive" (RTR), for ANDAs, for an electronic submission that does not have study data in conformance to the required standards specified in the Catalog. Therefore, for all studies with a start date of 24 months after the publication of this guidance, applicants must submit study data electronically and must use the appropriate FDA-supported standards, formats and terminologies specified in the Catalog when submitting study data. Our interpretation of this guidance places the clinical data electronic submissions requirement date at on or about September 15, 2017.

 

The second guidance document finalized by the FDA is titled Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act. This guidance describes how the FDA interprets and plans to implement the electronic submission requirements of section 745A(a) of the FD&C Act. Specifically, the FDA will issue individual guidance's for specifying the electronic formats for certain components of submissions under section 745A(a). Once the final individual guidance documents are issued, Industry will then have at least 24 months to comply with the electronic submission requirements specified in the applicable guidance, and that is pretty much all that this guidance speaks to.

 

Another electronic submissions guidance that Industry is still waiting on is titled Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Click Here) which is still in draft as of July 2014. This is the main guidance document that industry is waiting finalization of. Once approved, industry will have 24 months to comply with the requirement to submit all regulatory submissions to the FDA in electronic (eCTD) format. But at this point, we are probably looking at 2019 before electronic submission of INDs, NDAs, ANDAs, and BLAs becomes a requirement.

 

As Senior Project Manager for Protocol Link, I have been working as the Regulatory Designate for various US and International Pharmaceutical Manufacturers for the past 5 years. In that capacity, I have authored, prepared, published and submitted their regulatory submissions in the eCTD format as well as assisted them with their document life cycle management. I have also performed ongoing regulatory affairs management of their commercial products in the marketplace. Protocol Link can work alongside your core team as your RA partners to develop streamlined and effective regulatory filing strategies and ensure that your compliance elements and deadlines are achieved. We can also assist with any regulatory submission (ARs, Supplements, etc.) backlog you may have.  Please contact me at rcerny@protocollink.com.
A Word From Our Staff

"Successful organizations are built with talented people who adapt their skills and experiences in the work environment to yield Breakthrough Performances. Our success as an organization over the past 20 years is a direct result of such adaptation; listening to our clients, understanding their challenges, and implementing fresh innovative and practical approaches. This new year is a special opportunity for me to thank you for your endorsements in 2014 that made possible the accomplishments and set a resolution for 2015 to do all we can to achieve continued levels of performance." 

-Dipak Doshi, Chief Executive Officer
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