FDA Loosens Approval Requirements for Several Health Care Devices

The FDA released draft guidance on a wide-ranging list of medical devices -- including those that fall into the mobile health care category -- that the agency believes do not require premarket authorization, MobiHealthNews reports (Dolan, MobiHealthNews, 8/1).

Details of Guidance

In the proposal, FDA identified several:

  • Class II medical devices that the agency says no longer need a 510(k) review to ensure their safety and effectiveness; and
  • Class I medical devices that the agency says do not meet the "reserved" criteria of the Federal Food, Drug and Cosmetic Act (Slabodkin, Health Data Management, 8/1).

Among the devices that would be affected by the guidance are several smartphone-enabled tools, such as:

  • Clinical digital thermometers;
  • Ophthalmic cameras; and
  • Stethoscopes (MobiHealthNews, 8/1).

The draft guidance states, "The FDA believes devices identified ... are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness."

It adds that the agency "intends to propose exempting these devices from premarket notification" (Motti, FierceMobileHealthcare, 8/1).

FDA also said it does not plan to enforce compliance with premarket authorization requirements for those devices and does not expect manufacturers to submit 510(k)s for such devices before a final rule is published (Health Data Management, 8/1).

However, FDA clarified that the move to exempt certain devices from premarket authorization processes would not necessarily exempt devicemakers from other regulatory steps, such as:

  • Appropriately registering and labeling their products as medical devices; or
  • Quality systems requirements (MobiHealthNews, 8/1).


Bradley Merrill Thompson, an attorney who counsels medical device makers on FDA regulations, said the draft guidance is "big news and a huge boost to the mHealth industry." He added, "It shows that FDA is being extremely practical in reviewing its own practices and updating its regulatory requirements where the risks simply do not merit the investment of regulatory resources" (Health Data Management, 8/1).

Source: iHealthBeat, Monday, August 4, 2014

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