Recently, the Food and Drug Administration (FDA) opened up a public comment period, extending to mid-January, to get perspective on whether the information gathered during reclassification submissions of medical devices is necessary and useful, whether it’s gauge on timing and burden is appropriate, and how to improve on the process and minimize burden.
According to an article from MassDevice, FDA “is also looking for ideas on how to use automated collection techniques and other forms of information technology to make the submission process easier.”
The medical device reclassification process allows parties to request that a device be subject to more or less regulatory oversight. The classification system determines a device’s regulatory pathway, with Class III devices subject to the most control and Class I devices subject to “general controls” on branding, registration and other mostly administrative concerns. Bumping a device into a lower class means manufacturers can bring similar products to the U.S. market more quickly and with fewer regulatory hurdles.
Comments are due January 13, 2012 and can be submitted electronically at
http://www.regulations.gov, Docket No. FDA-2011-N-0776.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
All comments should be identified with the docket number found in brackets in the heading of this document.
For more information, contact Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-5156, Daniel.Gittleson@fda.hhs.gov.
Background
Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), subpart C, FDA has responsibility to collect data and information contained in reclassification petitions. The reclassification provisions of the FD&C Act allow any person to petition for reclassification of a device from any of the three classes, i.e., I, II, and III, to another class.
The reclassification procedure regulation requires the submission of specific data when a manufacturer is petitioning for reclassification. This includes a “Supplemental Data Sheet,” Form FDA 3427, and a “Classification Questionnaire,” Form FDA 3429. Both forms contain a series of questions concerning the safety and effectiveness of the device type.
Further, the reclassification content regulation (Sec. 860.123) requires the submission of valid scientific evidence demonstrating that the proposed reclassification will provide a reasonable assurance of safety and effectiveness of the device type for its indications for use.
Thus, the reclassification provisions of the FD&C Act serve primarily as a vehicle for manufacturers to seek reclassification from a higher to a lower class, thereby reducing the regulatory requirements applicable to a particular device type, or to seek reclassification from a lower to a higher class, thereby increasing the regulatory requirements applicable to that device type.
If approved, petitions requesting classification from class III to class II or class I provide an alternative route to market in lieu of premarket approval for class III devices. If approved, petitions requesting reclassification from class I or II, to a different class, may increase requirements.
FDA said it reviews about six reclassification submissions each year. Each submission takes about 500 hours to process, amounting to about 3,000 hours every year spent on making reclassification decisions.