One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015.
To help meet that challenge in a way that benefits both government and the trade community, import entries of products regulated by FDA are submitted through an electronic system called the Automated Commercial Environment (ACE). A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States. The effective date of the rule is December 29, 2016, 30 days from the date of publication.
The trade community helped us pilot ACE, which is operated by U.S. Customs and Border Protection (CBP), from August 2015 to May 2016. In July 2016, ACE became the sole CBP-authorized system for electronic submissions of entries that contain FDA-regulated products.
The rule also includes technical revisions to certain sections of FDA regulations:
- The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws. (21 CFR 1.83 and 21 CFR 1005.2)
- FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice. (21 CFR 1.90)
- FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction. (21 CFR 1.94)
- The rule clarifies that FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule.
As a result of the more streamlined import process for FDA-regulated products provided by ACE, the rule is expected to lead to an efficient use of FDA and importer resources, and more effective enforcement of laws and regulations enforced by FDA.
Key compliance dates in the UDI final rule.
|September 24, 2014||All Class III devicesThe labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).
|September 24, 2015||Class II Implantable, life-saving, and life-preserving DevicesThe labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18.|
|A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45.Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).|
|Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.|
|September 24, 2016||Remaining Class II DevicesThese are required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.|
|The labels and packages of class II medical devices must bear a UDI. § 801.20.Dates on the labels of these devices must be formatted as required by § 801.18.Class II stand-alone software must provide its UDI as required by § 801.50(b).|
|Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.|
|September 24, 2018||All Remaining DevicesDevice that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.|
|The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.|
|Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.Class I stand-alone software must provide its UDI as required by § 801.50(b).|
|Compliance dates for all other provisions of the final rule. Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.|
These compliance dates will impact 510k and PMA submissions. Contact us and our FDA Regulatory Consultant will help you guide your firm through the new paradigm.
The purpose of the FDA Pre-Submission Program* (formerly Pre-IDE) and Meeting with FDA is to provide a mechanism for applicants through which they can request feedback from the Food and Drug Administration (FDA) regarding potential or planned
1) Medical device Investigational Device Exemption (IDE) applications,
2) Premarket Approval (PMA) applications,
3) Humanitarian Device Exemption (HDE) applications,
4) De novo Petitions (Evaluation of Automatic Class III Designations ),
5) Premarket Notification (510(k)) Submissions,
6) Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application,
FDA Feedback may include
a) Written feedback by email
b) Conference call (max 1 hour)
c) Face-to-Face Meeting (max 1 hour)
For #a and #b – Meeting minutes must be drafted and submitted for FDA review. Approved minutes become part of the Pre-Submission record
Contact Glen Feye -FDA regulatory consultant– at glen@accuratefdaconsultanting for help with planning, submitting and leading Pre Submission meeting
*Per 2012 Draft FDA Guidance titled- The Pre-Submission Program and Meetings with Food and Drug Administration Staff
IN LIMBO ON THE BORDER – by Glen Feye
FDA is the main gatekeepers for foreign Medical Devices and Drugs imported into the United States.
If your shipment is questioned by FDA and receive a “Notice of FDA Action” contact your US Agent and you may need a FDA Compliance Consultant .
If your shipment is non compliant- expect “HOLD DESIGNATED”
If the appropriate action is not taken in a timely manner- expect ” REFUSAL OF ADMISSION”
FDA wants these products out of the country or distroyed in a timely manner
1) Letter of Authorization
All FDA communications must include the Entry Number
If you are working with a third-party consultant – FDA requires a Letter of Authorization from firm
2) Current FDA Registration and Device Listing-
Note-This is an annual process- and medical devices manufacturers must pay the appropriate User Fee by the beginning of the upcoming year
3) Regulatory Status- Devices and Drugs
Define product mix. Develop a comprehensive spreadsheet which defines the following:
Define device classification based on intended use of device as well as the appropriate product code and device listing
Identify 510k or PMA number(s)
Device accessories are devices
Components are not devices
Define drug based, – obtain the NDC numbers.
Navigating through this process and getting proper communication with FDA is challenging.
Contact www.accuratefdaconsulting.com or call a FDA Consultant to get help to properly remediate these import complications