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Compliance In Focus
Posted by Brandy Chittester on Wed, Mar 13, 2013

New FDA Guidance- Help or Hurt the Device Review Process?

In response to The Medical Device User Fee Amendments of 2012 (MDUFA III), which authorizesNew Guidance  helping or hurting the FDA to collect user fees for the review of certain premarket submissions, the FDA proposed process improvements  to provide further transparency to the review process, including new communication commitments. These new communications are in the context of acceptance review, substantive interactions, and missed MDUFA goals. The communications are outlined in the MDUFA III Commitment Letter and are further described in the draft guidance released on March 5, 2013 titled Types of Communication During the Medical Device Submissions.

The guidance reviews four types of communications and the types of medical device submissions for which they apply:

1) Acceptance Review Communication

a. Premarket notification submission (510 (k)s)
b. Original premarket approval applications (original PMAs)
c. Panel-Track PMA Supplements

Purpose: To identify the lead reviewer assigned to the submission and confirm acceptance or notify the submitter that the submission was not accepted based on the review of the submission against acceptance criteria. The outcome of this review, based only on completeness and not intended to identify deficiencies, should occur with in 15 days of receipt by fax, email, or other written communication.

2) Substantive Interaction

a. 510 (k)s
b. Original PMAs
c. Panel-Track PMA Supplements
d. 180-Day PMA Supplements

Purpose: To communicate that the FDA intends to work with the applicant to resolve outstanding deficiencies or that identified deficiencies warrant a hold on the submission. Substantive Interaction should occur with in 60-90 days of receipt of the depending on the type of submission, following the acceptation and a complete review.

3) Interactive Review

a. 510 (k)s
b. Original PMAs
c. PMA Supplements
d. Original Biologics License Applications (Original BLAs)
e. BLA Supplements

Purpose: To facilitate the efficient and timely review by increasing interactions between the applicant and the FDA to exchange scientific and regulatory information and address deficiencies that are minor without placing the submission on hold.

The goal of the review is to:

  • Improve interaction
  • Decrease unnecessary delays and reduce overall time to market
  • Ensure clear communication of the FDA’s concerns noted during the review process
  • Minimize the number of review cycles
  • Minimize the number of review questions conveyed through deficiency letters
  • Ensure timely responses from applicants

Further information and details can be found in the IMARC blog titled- Can updates to the Interactive Review for medical device submissions improve approval time?

4) Missed MDUFA Decision Communications

a. 510 (k)s
b. Original PMAs
c. Panel-Track PMA Supplements

Purpose: To facilitate a timely resolution to any outstanding issues that has precluded the FDA from reaching a decision prior to the MDUFA decision goal. A communication, in writing, should occur for those submissions by 100 FDA days for 510 (k)s and 20 FDA days after the applicable FDA goal for Original PMAs and Panel-Track Supplements. The feedback should include:

  • All outstanding issues with the application preventing the decision
  • Action items for the FDA and applicant
  • The estimated completion date for the action items identified for each party
  • Proposed dates for meetings from which the applicant may choose

he guidance aims to incorporate the expanded use of the above noted communication tools to increase the efficiency and decrease the timelines of the review process.

Do you think that these new proposals will decrease time to approval or create confusion? Will these new communication tools create additional barriers to approval?

Photo Credit: Colin K

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Topics: New FDA Guidance, MDUFA, Device Review Process

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