Bioelectronics Corp (BIEL)

[srinsocal]

RecoveryRX XTRA should qualify for a "Special 510k", 30 Day process

“The Special 510(k) Program” guidance document, issued in September 2019, describes an optional pathway for manufacturers that make certain well-defined modifications to their own legally marketed device. The guidance was developed to clarify existing policy and the types of changes that are appropriate for the program in an effort to improve the efficiency of 510(k) review, consistent with the FDA’s least burdensome principles. The program allows FDA and industry to rely on previous agency review of detailed information and manufacturers to provide the minimum required information necessary to establish substantial equivalence (SE) for a modified device. As a result, special 510(k)s are processed within 30 days of receipt by the Document Control Center instead of 90 days as for Traditional or Abbreviated 510(k)s.