Dive Brief:
- Final guidance on a variety of topics including the Safer Technologies Program for medical devices, labeling recommendations for surgical staplers, clinical decision support software and device-specific Safety and Performance Based Pathway implementation are among FDA's priorities for the 2020 fiscal year, the agency announced Friday.
- A variety of device safety draft guidance initiatives on revising procedures for handling post-approval studies imposed by PMA order, labeling and an informed decision checklist for breast implants, and device cybersecurity management content in premarket submissions, are also top action items for FDA.
- The annual publication comes days after the White House issued an executive order aimed at limiting federal agencies' use of the documents by, among other requirements, necessitating Office of Information and Regulatory Affairs review of significant guidance documents before issuance.
Dive Insight:
The FDA relies heavily on guidance documents to explain its thinking on complex regulation to a healthcare industry hungry for the information.
The White House executive order instructs government agencies to maintain a website listing guidance documents and to state in any new guidance documents they are not legally binding. It also instructs agencies to eventually issue procedures to petition for the withdrawal or modification of guidance documents.
"All too often, guidance documents are a backdoor for regulators to effectively change the laws and vastly expand their scope and reach," President Donald Trump said at the signing of the executive order. "Guidance has frequently been used to subject U.S. citizens and businesses to arbitrary and sometimes abusive enforcement actions."
Alexander Gaffney, a healthcare regulatory expert at PwC, noted on Twitter FDA already publishes guidance agendas, collects comments and has a disclaimer noting they are not legally binding.
The Executive Order on guidance documents is out this evening. You can read it here: https://t.co/yM0p3jThUI
— Alexander Gaffney (@AlecGaffney) October 9, 2019
My top-line thought for FDA: The agency already complies with a ton of this. A few exceptions on major guidance, but not many I can think of.
FDA declined to comment on the executive order's potential impact on the agency, directing questions to the White House.
Draft guidance is also expected on "pragmatic generation of validity evidence for patient-reported outcome measures used in medical device submissions" and "distinguishing between medical device servicing and remanufacturing."
If resources permit, two additional final guidances FDA said it intends to publish in the coming year address blood glucose monitoring test systems for prescription point-of-care use and self-monitoring blood glucose test systems for over-the-counter use.
