The US FDA announced the launch of a pilot regulatory project related to the “Software as a Medical Device” (SaMD) in the course of amendments to the medical devices certification rules.

2019 Test Plan


The development of technologies and regulatory needs are arising in connection to the widespread use of apps for medical purposes.  As a result, the US regulating authority developed a special program for certification, aimed to improve the efficiency of the registration procedure. The Software Precertification (Pre-Cent) Program is a special registration procedure developed in accordance with the specific features of the sphere to protect the public health and create favorable framework for innovative projects related to softwares.
This program uses Excellence Appraisals as the main principle in the application review.

In the beginning of implementing new principles, the FDA is going to use the De Novo classification process during the pilot program. De Novo is a special type of application created for cases when the product seeking for regulation is brand new and has no analogues present in the market. Therefore, it is necessary to define the type of the product and appropriate safety Class based on its specific features.
For example, such a procedure has been applied to the certification of smart watches with built-in cardio sensors (as a result, they were defined as Class 3 medical device). De Novo procedure will greatly benefits innovative products. In the future, Pre-Cert Program will be based on principles of De Novo registration procedure, that specifically applies to the SaMD. According to the plan, the new regulatory model would initially be tested internally by the FDA through the retrospective testing, using data on previously submitted application. Then it would proceed to go through the Pilot program, including participation of volunteer software developers.


New regulatory approach


The entire goal of the Test Plan is to define the efficiency of the proposed regulatory procedure and its applicability to the SaMD certification process. To evaluate the efficiency of the new reviewal procedure, the regulating authority will apply both procedures (Pre-Cert and standard one) and then compare the outcomes.

Testing would include these two main steps:

  1. Retrospective tests – new procedures will be applied to the FDA-reviewed applications to find out if there are any differences in reviewal results take place.
  2. Prospective test – new procedures will be applied to several new submissions for the pre-market review. The use of both evaluation types will allow the review of efficiency and applicability of the new method. At the same time, submissions suitable for such test will have to include all the information needed according to the each reviewal procedure requirement.

The final decisions during the evaluation period will be based on an official procedure.  Since the new procedure has no appropriate legal status, the decisions based on Pre-Cert evaluation would have no legal power.
The regulating authority is also going to create a mock submission to inform the potential applicants on the new requirements and information that should be provided.
The reasonability and adequacy of mock submission content would be based on the principles of scope of information that will provide enough reasonable assurance in safety and efficiency of the product.

About RegDesk

Software as a medical device products are becoming increasingly popular nowadays; many people have smartphones that could be used to collect and analyze information related to health and physical condition.  At the same time, some of such applications may fall within the scope of regulatory requirements for Class 1 or even Class 3 medical devices. Due to the innovative nature of this sphere, there is no regulatory clarity and developed framework, since all the arising issues are new to both software developers and regulating authorities. RegDesk will keep you acknowledged on the latest amendments in SaMD regulations in the USA and in all the other countries. 

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