- FDA is seeking comments from the public on information required for submitting medical device applications for pediatric populations.
- The agency is asking for input on whether the proposed collection of information is necessary for it to perform its functions, on the accuracy of the estimated burden of gathering the information, ways to enhance the usefulness of the information collected, and ways to minimize the burden on respondents.
- The information it collects will help in tracking how many devices are approved to treat, diagnose or cure a condition affecting a pediatric subpopulation and the review time for those applications, FDA said in a notice published Friday.
FDA highlighted the challenges involved in developing pediatric medical devices at a public workshop last year that underscored issues such as the difficulty in running clinical trials and the struggle to justify funding due to the small market size. The agency has provided incentives to encourage pediatric device development including grants, ways to leverage existing clinical data, acceptance of studies from outside the U.S., and early feasibility and expedited access programs.
The approval last week of a breakthrough-designated device to treat recurrent ear infections in adults and children is a bright spot in efforts to advance pediatric device treatments. Tusker Medical’s ear tube system offers a simpler procedure that can be performed in a doctor’s office and requires only local anesthesia.
Another advancement for children recently approved by FDA is CooperVision's disposable contact lens indicated for ages 8 to 12 that is designed to slow the progression of myopia, or nearsightedness.
In its notice seeking public comment on the collection of information on pediatric devices, FDA said it expects to receive about 47 original premarket approval, product development protocol or humanitarian device exemption submissions each year, basing that estimate on the average of new applications that it receives.
The agency estimates that 11 of the projected 47 submissions will lack the required pediatric use information and will therefore require PMA amendments. FDA said it also expects to receive about 928 supplements that will include required pediatric use information.
It estimated compliance requires just eight hours to organize and submit the necessary information, while supplement information can be obtained and submitted in only two hours if referencing a previous submission. The 2014 guidance document "Providing Information About Pediatric Uses of Medical Devices — Guidance for Industry and Food and Drug Administration Staff" describes how to compile and submit required pediatric use information.
FDA is asking the public to comment on four topics:
- Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether it will have practical utility.
- The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
- Ways to enhance the quality, utility and clarity of the information to be collected.
- Ways to minimize the burden of collecting information on respondents, including through the use of automated collection techniques and other forms of information technology.
Comments are due 60 days from publication of the notice in the Federal Register.