The FDA continues to roll out new guidance documents for medical device regulations—this time presenting updated rules for postmarket surveillance.
The draft entitled “Postmarket Surveillance under Section 522 of the Federal Food, Drug and Cosmetic Act,” released by the FDA on August 16, provides a summary of the revised postmarket surveillance program, including new modifications.
The most notable change involves the time frame for postmarket surveillance of devices used primarily within the pediatric population
According to the draft, the FDA requires postmarket surveillance “for a duration of up to 36 months, unless the manufacturer and the FDA agree to extend that time frame.” Now, however, the agency can require a longer period of surveillance if the device is going to be used primarily in children . . . “if such period is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device.”
Extended post-market surveillance will likely be a condition for 510(k) clearance or PMA approval of devices, especially Class II and Class III medical devices with significant pediatric applications. The length of extended time has not defined.
The FDA indicates that the scope of Section 522 postmarket surveillance for “Class II and III devices that are expected to have a significant use in pediatric populations is not limited to devices labeled for pediatric uses; accordingly, FDA may use this authority to order surveillance of devices expected to have significant off-label use in pediatric populations.”
Pointers in the document regarding filling out postmarket surveillance study submissions include the study design, sample size calculations, and description of data collection procedures (including recruitment plans, enrollment targets, quality assurance, and control).
Comments and suggestions are welcomed within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be submitted to http://www.regulations.gov.
Once finalized, the new document will replace “Guidance for Industry and FDA Staff; Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act” issued April 27, 2006.