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Best PracticesFDA IssuesImportMedical Devices

FDA Launches New Webpage to Promote Use of Symbols in Medical Device Labeling

posted by Jennifer Diaz April 28, 2017 0 comments

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA insigns June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

  • Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
  • Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
  • Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
  • The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

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Best PracticesCBPDepartment of Homeland SecurityImport

Do You Keep Your Manifest Information CONFIDENTIAL?

posted by Jennifer Diaz April 15, 2013 0 comments

Did you know importers and consignees can request that U.S. Customs and Border Protection (CBP) keep your manifest information confidential?

If you are currently letting your competitors know your source, read on, and learn how to keep your private data private!

Pursuant to the privacy statute, 19 C.F.R. § 103.31 (d) the public is allowed to collect manifest data (e.g., bills of lading) at every port of entry. This information is limited to vessel manifests. Air, rail, and truck manifests are not available to the general public in any form.

 

Websites such as panjiva.com, datamyne.com and importgenius.com (to name a few) collect and publish the names of importers, suppliers, and manufacturers from vessel manifest data. This can be troubling for some, as your competitors are able to access information related to the sourcing and/ or manufacturing of your products. However, an importer/shipper may make a request to CBP for confidentiality. The confidential protection is valid for 2 years, thereafter, you have to renew your request.

 

The public may obtain manifest data at every port of entry. However, Section 103.31 states that

Only the name and address of the shipper, general characteristics of the cargo, number of packages, gross weight, name of the vessel, port of exit, port of destination, and country of destination may be copied and published.

The regulation also states that

An importer or consignee may request confidential treatment of its name and address contained in inward manifests, to include identifying marks and numbers. In addition, an importer or consignee may request confidential treatment of the name and address of the shipper or shippers to such importer or consignee.

It is essential that you send in renewal requests 60 days prior to the expiration of the 2 year confidentiality period.  The importer will receive a response when the confidentiality request has been granted and it will state the effective time period.

 

CBP sent a message to trade on Feburary 7, 2013 (CSMS #13-000064), titled "improperly formatted ACE ocean manifest data resulting in release of confidential data."  CBP made it clear that after an importer requests confidentiality, and its granted by CBP, the importer must be sure the commercial party names submitted to CBP always match – CBP will not grant confidentiality if you use any variation of the name originally requested. One incorrect keystroke by an individual who is processing the information can result in a new variation of company information that is not covered by the grant of confidentiality. CBP has stated that the release of confidential data is strictly the result of improper data entry by users and not by CBP programming or system errors. 

 

To assure you send an effective request for confidentiality and so your competitors don’t have access to your private data, contact me today!

FDA IssuesFoodFSMA

On February 1, 2013 Many Food Facilities Face Suspension

posted by Jennifer Diaz January 22, 2013 0 comments

The U.S. Food and Drug Administration (FDA) extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S. 

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food, alcoholic beverages, and/or dietary supplements for consumption in the U.S. are required to register the facility with the FDA. 

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse. 

New Biennial Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 (in this case, October 22) and ending on December 31 in even numbered years. This will first occur in October-December 2012 (which FDA extended until January 31, 2013, as renewals did not start until October 22).

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 22– January 31, 2013 extended registration renewal period.

U.S. Agent

FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

  1. live or maintain a place of business in the U.S. and
  2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of "reinspection fees" of foreign facilities and failure to comply with recall orders. Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food safety. The purpose of the reinspection is to assure the issue has been remedied and food is now safely produced. Fees are adjusted each fiscal year. For FY 2013 (October 1, 2012-September 30, 2013), the fees are steep, at $221 an hour if no foreign travel is required, and $289 an hour if foreign travel is required.

Need a U.S. Agent?

The law firm Becker & Poliakoff, P.A. provides registration services and will act as a U.S. agent with the FDA for a nominal fee, but, the foreign facilities are always responsible for the payment of any reinspection fee or fee for a failure to comply with a recall order. Please visit www.FDA-USA.com for more information about how to make Becker & Poliakoff, P.A. your U.S. agent with the FDA.

Contact Jennifer Diaz with any questions  and ensure your importation are not delayed come February 1, 2013.