FDA, Industry See Progress in MDUFA IV Negotiations.

At the second meeting it focuses on the fourth iteration of user fees for medical devices (MDUFA) agreements for 2017 as the Food and Drug Administration (FDA) and industry agreement reiterated that the overall program is improved and heads in a positive direction.
The negotiations focus on the use of a system whereby medical device companies pay fees to the FDA to register their establishments and list their devices with the agency. The fees help increase the effectiveness of the regulatory process of the FDA, with the aim of reducing the time needed to bring safe and effective devices on the market.

Negotiations

In early October, employees of the FDA Center for Devices and Radiological Health (CDRH) met with representatives of industry groups including AdvaMed Industry, Medical Imaging and Technology Alliance (MITA), the American Clinical Laboratory Association ( ACLA) and the Medical Device Manufacturers Association (MDMA)
The two sides discussed the FDA's response to an analysis of requests for pre-investigational device exemption (IDE) has asked the industry, examined CDRH information systems for pre-marketing review and discussed the implementation of the MDUFA recommendations Booz Allen Hamilton II / III evaluation and additional financial analysis.

Pre-bidding for FDI

In explaining the results of a pre-bid for FDI analysis, based on a sample audit of fiscal year 2013 and part of 2014, the FDA said it determined that the IDE with previous memories have a higher probability that the first cycle approval.
An investigational device exemption (IDE) allows the device to be used in a clinical study to collect data on safety and efficacy. Clinical trials are most often carried out in support of an application for premarket approval, while a small percentage of the 510 (k) s require clinical data to support the application.
"Although the available data support the conclusion that FDI with pre-memories have a greater chance of approval, the significance of this finding is complicated by the fact that the data shows that it may take more time to study an IDE approval when was preceded by a pre-bid, "the FDA said.
FDA noted the increase of time is often due to the pre-bid is associated with the most difficult IDE studies.
Another key finding was that the presentation of the FDA and Q-novo workload has increased. Q-arguments refer to the documents submitted by the promoters of feedback from the FDA called before a meeting IDE. And de novo sort option is an alternative way of categorizing new low to moderate risk devices that were automatically placed in Class III after receiving a "not substantially equivalent" decision in response to a (k) 510.
The FDA also describes the trend in the number of submissions and pre-submission of thematic meetings (SIMS) increase, despite an increase in submissions for which there is no charge, the FDA said it continues to meet its objectives performance.
The agency also said Examiners provide information before the presentation pre mostly for fiscal year 2015 than in previous years, when the industry enjoyed meetings.
As for the orientation, the industry also welcomed the efforts of the FDA to provide clarity through revisions guidance documents, even if "can inject more uncertainty because many are associated with new initiatives that require staff FDA and the industry time to respond. " CAWA, for example, expressed concern about the use of guidelines rather than formal comments and regulations for major policy changes.

Evaluation MDUFA

Also at the meeting, the FDA CDRH presented a summary of the implementation of a plan to address the recommendations of MDUFA II / III evaluation of Booz Allen Hamilton, which includes 11 recommendations for FDA to improve the efficiency of time and consideration a review of the presentation of the device process.
The five categories of recommendations are Quality Management, Evaluation of the review process, the evaluation of infrastructure and workload Tools, evaluation of training programs, evaluation and billing.
CDRH said it has completed the groundwork for seven of the 11 recommendations, including the four projects on the recommendation of quality management. Other preliminary actions met in December 2015, the FDA should.

Finance

The FDA said there was a decrease of the budgetary authority (BA) Credits for medical devices for the fiscal year 2013 due to the kidnapping, and the agency has met the trigger on credit line devices and radiation health budget annually MDUFA III so far.
FDA has agreed to provide additional information about the 510 (k) program novo and industry at the next meeting on 18 November.