Factors influencing the time for FDA review of medical devices

Companies must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application (PMA) is the process by which this occurs. Companies submit a PMA after they have completed laboratory test, animal studies and human clinical trials to demonstrate the safety and effectiveness of the device for a specific condition, or therapeutic indication. Despite legislation in the early part of this decade to reduce the timeframe for FDA review of PMAs, these timeframes continue to vary dramatically and unpredictably from months to many years. The focus of this thesis is to examine factors which influence this timeframe. Hypotheses about factors that impact PMA review timeframes were developed by analyzing the review process and through interviews with industry representatives and FDA officials. The following factors were evaluated: year of submission to FDA, size of firm seeking approval, presence of prior approved PMAs by firm seeking approval, product category, first-of-a-kind device, number of amendments, expedited review status, advisory panel review, unanimous advisory panel vote, and confirmation of primary efficacy endpoints in pivotal clinical trials. The year of submission was considered a control variable. The other factors fall into one of three categories: applicant characteristics, device characteristics, and process characteristics. Analysis was limited to PMAs received by FDA from 2000 through 2005. Two levels of analysis were conducted.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2007

Author dc:creator

• Singh, Inder Raj, S.M. Massachusetts Institute of Technology

Advisor dc:contributor.advisor

• Fiona Murray and Stan Lapidus.

• Harvard University--MIT Division of Health Sciences and Technology.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/42216

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/42216