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New FDA Plan for Medical Device Approval Process

Good news for businesses looking to approve medical devices within the United States: the Food and Drug Administration (FDA) wants to speed up approval of new medical devices, bolstered by President Trump and the medical device industry. The U.S. government is known for long-term medical device approval process, as well as long processes surrounding approval of new pharmaceuticals, which patients, doctors, health professionals, and creators of new medical devices often complain about.

Why Was the Medical-Device Approval Process Sped Up?

The new Medical Device Approval Process plan was designed by the Pentagon and the FDA in an effort to expedite the FDA Approval Process of specific products meant for use by U.S. troops on the battlefield. Specifically, the Department of Defense wants to approve three products that it hopes will prevent or help prevent soldiers from bleeding out on the battlefield during conflicts. These three products are cryopreserved platelets, cold-stored platelets, and freeze-dried plasma. Moving these products to the conflict zones where they are needed requires the cooperation of the Pentagon and the Center for Biologics Evaluation and Research at the FDA, known as CBER. Previously, the FDA had refused to approve freeze-dried plasma for ten years, protesting that 2017’s National Defense Authorization Act (NDAA) did not provide strong enough testing and allowed the Pentagon to develop medical devices and treatments unrelated to the battlefield.

How Will the New Medical Device Approval Process Work?

The Pentagon and CBER’s leadership will meet quarterly to discuss new medical devices the Department of Defense considers priorities, labeling them as “breakthrough” therapies which will allow faster development and review for devices assisting soldiers with serious medical conditions. Working together, the FDA and the DoD will design the product development guidance and release more information via their government websites and in press releases following formal meetings at least every six months. The product development pipeline will also be examined during each of these meetings to determine whether changes should be made.

Why Are Healthcare Professionals Worried About the New Medical-Device Approval Process?

The new process will allow progressive medical device approvals, meaning that some devices would be allowed to go to market with initial approvals and some research, with full performance information and research conducted only after patients are already using the devices. Some physicians, such as Dr. Rita F. Redberg who edits the Journal of the American Medical Association’s (JAMA) Internal Medicine division, fears that speeding up the approval process by reducing patient safety is not a good risk. Redberg also pointed out that “most post-marketing studies are not started or not completed” and the data from these studies is never made available to healthcare professionals or their patients.

Problems with Medical Device Approval Processes in the Past

Another worrisome issue surrounding medical device approval in the United States is that the policy was already considered “lenient” prior to NDAA passage -- as a result, many patients have suffered due to health issues from devices such as the following (according to The Wall Street Journal):

  • Degenerating metal-on-metal hip replacements
  • Power morcellators (uterine-surgery devices) that spread cancer
  • Fractured defibrillator wires causing patient deaths

Scott Gottlieb, the U.S. Food and Drug Commissioner, is in favor of approving new medical devices and advances faster for patients and medical device companies, but emphasized that safety must be paramount. Presently, “dozens” of medical devices are recalled each year.

How the Medical Device Approval Process Could Help Patients

Patients waiting on the FDA Approval Process for medical devices could see the approval time reduced considerably, but may be sold devices that were not tested per the FDA’s previous policy, including patients who are not on the battlefield in the U.S. military. While the policy was intended to help battlefield patients, it will also change the policy for other medical device companies.

How the Medical Device Approval Process Could Help Medical Device Companies

Medical device companies are on the winning side of this policy change, because it will save them “millions of dollars in product testing and shave years off development times,” according to Reuters. The process will also increase sales of medical devices.

Overview of Medical Device Approval Process Changes

Currently, the FDA’s Center for Devices and Radiological Health (CDRH) regulates all medical devices sold in the U.S., including manufacturing, repackaging, relabeling and importing of such devices. Medical devices are classified as Class I, II, and III, and the following are required of medical device manufacturers in the U.S.:

  • Establishment registration
  • Medical Device Listing
  • Premarket Notification 510(k) or Premarket Approval
  • Investigational Device Exemption for clinical studies
  • Quality System regulation
  • Labeling requirements
  • Medical Device Reporting

Under the current medical device approval process, the 510(k) pathway offers companies manufacturing medical devices that are moderate risk and similar to existing marketed devices (predicates) approval; high-risk products still follow the main policy. Gottlieb believes difficulties facing companies without a predicate for the review process can hold those devices back from the market and patients, and that high-risk products could be sped to market once the amount of necessary product safety data has been re-evaluated.

While the new policies may cause risk to patients, they may also allow much-needed medical device products to reach the patients they are intended for, faster. The final rules and regulations will be decided upon by the FDA and the Department of Defense.

The Arbour Advantage with Medical Device Compliance

Arbour Group is dedicated to bringing your organization all of the necessary tools for regulatory compliance. We assist medical device and pharmaceutical companies in maintaining regulatory compliance with the FDA and other international regulatory agencies. Learn how Arbour Group can help your organization maintain it's medical device compliance.