• AdvaMed, Device Companies Claim FDA's 510(k) Pre-Review Guidance Lacks Objectivity

    Several prominent members of the medical device industry, including its largest trade group, have voiced their concerns about a new guidance document released by the US Food and Drug Administration (FDA) that would consolidate and expand the agency's pre-review policies for some medical device applications submitted through the 510(k) pathway. The guidance, Refuse to Accept (RTA) Policy for 510(k)s , is intended to make it easier for FDA to filter out inadequate sub...
  • New 510(k) Guidance Consolidates Pre-Review Policies

    A new draft guidance document published by the US Food and Drug Administration (FDA) establishes the criteria under which the agency can refuse to accept a 510(k) substantial equivalence application submitted to the agency. 510(k) applications are used to approve devices which are based upon and otherwise substantially equivalent to medical devices approved by FDA. Under the 510(k) process, devices are cleared-not approved-by the agency if they can show substantial equiv...