The FDA is looking to shove its medical device review process into the digital age with a draft proposal that would require medical device makers to submit review applications in digital form starting January 2013.
The eCopy system for submitting electronic applications is already online, but use is voluntary for the time being. The FDA’s latest draft guidance would require that all applications include both a paper copy and a digital copy, in hopes of streamlining the review process by allowing immediate access to submissions, rather than relying on distribution of paper copies.
If approved, the eCopy requirement would affect a large swath of medtech applications, including:
- Premarket notification submissions (510(k)s), including third party 510(k)s
- Evaluation of automatic class III designation petitions (de novos)
- Premarket approval applications (PMAs)
- Modular PMAs
- Transitional PMAs
- Product development protocols (PDPs)
- Investigational device exemptions (IDEs)
- Humanitarian device exemptions (HDEs), including Humanitarian Use Device
186 designation requests (HUDs) - Certain investigational new drug applications (INDs)
- Certain biologics license applications (BLAs)
- Pre-Submissions
The agency doesn’t expect to provide any waivers from the program, given "widespread availability of software to enable the creation of an acceptable eCopy at little to no cost," according to the draft document.
The only forms exempt from the program are Compassionate use IDE submissions, Emergency use IDE submissions and Emergency Use Authorizations, although the FDA encourages eCopy submissions for those cases when possible.
The eCopy program would not change existing rules on the quantity of copies of each submission a device maker is required to provide, the agency noted, but the companies could submit multiple electronic copies as long as at least 1 paper copy is also provided.
The public comment period for the new proposal is open for 30 the next days.
