The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a “plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.” See FDA News Release, “FDA to improve most common review path for medical devices” (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of medical device reviews by CDRH.
The CDRH Plan, as proposed last August, outlines proposals for more stringent regulation, particularly regarding postmarket clinical trials. The Plan was modified prior to publication and in fact is not yet complete, since CDRH is giving the Institute of Medicine time to comment on seven recommendations prior to a final decision, and CDRH is also planning a public meeting in April to get feedback on two other proposals. The reason for the changes to the Plan, and its publication prior to issuance in final, can be explained in part by an attempt to comply with an Executive Order, issued by the White House on January 18, 2011, and discussed in the Wall Street Journal in an Op Ed piece. The Executive Order is available online and the Wall Street Journal Op Ed piece is available online.
The Executive Order provides in part:
(b) This order is supplemental to and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866 of September 30, 1993. As stated in that Executive Order and to the extent permitted by law, each agency must, among other things: (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
The revised CDRH Plan seemingly would do just that. In its News Release, CDRH highlights three of the proposals that should make it easier for industry to get products to market and protect jobs:
- Streamlining the “de novo” review process for certain innovative, lower-risk medical devices;
- Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process; and
- Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making.
The balance of the 25 proposals would clarify further the application of rules and requirements, address internal staffing needs and training, improve knowledge management, and seek to improve other programs, such as the Investigational Device Requirements. As reflected in press reports, industry spokespersons were complimentary regarding the CDRH efforts to comply with the Executive Order, while public advocacy groups were concerned that CDRH was trying to win a popularity contest.
The CDRH Plan of Action for Implementation of 510(k) and Science Recommendations is available online.