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FDA Issues New Import Data Requirements

FDA Issues New Import Data Requirements

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...

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Compliance Dates for UDI Regulatory Requirements

Compliance Dates for UDI Regulatory Requirements

Key compliance dates in the UDI final rule. Compliance Date Requirement 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...

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Strategic and Effective FDA Pre-Submissions

Strategic and Effective FDA Pre-Submissions

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...

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Our Core Team

Our experts are tireless and dedicated to delivering results.

Glen Feye, MS, and CQE

Glen Feye, MS, and CQE

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Barney King, MD, MBA

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