The Food and Drug Administration (FDA or the Agency) issued updated guidance on processes and standards for the inspections of medical device establishments.


Inspections Regulatory Backgrounds

The new approach to medical device establishment inspections is based on the rules and requirements introduced by the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52) and the appropriate provisions implemented to the Federal Food, Drug, and Cosmetic Act (FD&C Act). In particular, the document provides additional information regarding the communications methods to be used during the course of the inspection process. The present FDA guidance is a final version of another document dedicated to medical device establishment inspections issued by the Agency earlier in March 2019. 

For the purpose of this guidance, the term “standards” is related to “a level of quality or attainment” and thus should not be referred to as a “voluntary consensus standard.” 

The FDARA implemented the provision requiring the Agency to review existing processes and standards applicable to the inspection that medical device establishments should be subject to, and later replace them with uniform ones applicable in case of both domestic and foreign establishments. The appropriate requirements have been implemented in the FD&C Act. In accordance with these requirements, the Agency shall:

  • Inform the medical device establishment about the planned inspection in advance within a reasonable time,
  • Indicate the estimated time for inspection, and
  • Actively communicate with a representative of the medical device establishment, including its owners, in the course of the inspection. 

Under the FDARA, the Agency is also required to provide medical device manufacturers and other parties involved in operations with medical devices and detailed guidance describing all the aforementioned aspects related to the inspections to be held by the FDA. 

The scope of the guidance covers the inspections of medical device establishments registered under 21 CFR 607.80 and CFR 1271.1(b)(2). 

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Medical Device Establishment Inspections: New Approach

According to the information provided in the guidance, the FDA has fully reviewed all the processes and standards related to the inspection of both foreign and domestic medical device establishments dated August 2017. The scope of the review held by the Agency covered all existing guidance and manuals. On the basis of this information, the authority identified uniform processes and implemented regulatory measures necessary to remove any discrepancies between different procedures and standards. 

The Agency states that the unification of the approach to inspections and the way they should be carried out will assist medical device establishments in preparing for such inspections. 

In particular, the updated regulation on medical device establishment inspections provides several key improvements implemented by the FDA, namely: 

  1. Pre-announcement Notice and Communication. According to the new requirements, the FDA shall duly inform the medical device establishment subject to inspection in advance. An investigator shall contact the authorized representative of the establishment by telephone. Such notification should take place within a reasonable period of time before the planned date of inspection to be held by the FDA (at least 5 days in case of domestic establishment and more than 5 days for foreign). In any case, the notification should include details about the inspection (including the indication of its type and nature). If the establishment fails to acknowledge that such notification has been duly received, this should not be deemed as a reason for delay.
    When notifying the medical device establishment about the planned inspection, the FDA shall also indicate the working hours when the inspections are expected to take place and what records and additional information are to be requested by the FDA.
    It is also important to mention that the amended regulation prohibits the Agency from commencing the inspection without prior notification in accordance with the procedure described hereabove. 
  2. Standard Inspection Timeframe. As it is stated in the FDA guidance, the inspection timeframe should be in a range between three to six business days. The particular number of days needed to conduct the inspection depends on the type of inspection and its scope, and thus should be decided on a case-by-case basis. The authority shall duly inform the medical device establishment about the estimated timeframe of inspection in the course of pre-announcement. However, actual inspection time could be subject to changes due to the complexity of the case and other factors.
    In some cases, the timeframe could be extended, if such an extension is reasonably necessary, due to the additional post-market surveillance information received by the Agency. If there are no reasons justifying the extension, the inspection should be carried out within the initial timeframe announced by the FDA in the notification. According to the guidance, the Agency shall inform the medical device establishment subject to inspection without the undue delay.
    The aforementioned rules are applicable to both abbreviated and comprehensive surveillance inspections, and also to the pre-approval inspections of medical device establishments. 
  3. Communication During Inspection. The present FDA guidance also describes in detail the way the communication between the Agency and medical device establishment should be performed. First of all, an updated regulatory framework provides that regular verbal communications should take place in order to inform the establishment of the status of the inspection. The Agency shall take all reasonable efforts to discuss all important matters with the authorized representatives of the establishment (for example, on a daily basis) to avoid misunderstandings. In accordance with the guidance, such communications could be recorded by either party providing that it has been mutually agreed in advance. 

Summarizing the information provided hereabove, the present FDA guidance describes the new requirements related to the inspections of medical device establishments, introduced by the FDARA and implemented by the FD&C Act. In particular, the document provides additional details regarding three key improvements of the inspection procedures and standards: 

  • prior notifications to be submitted by the FDA before the planned inspection takes place, 
  • estimate timeframes of the inspection the FDA shall provide to the establishment and the reasons for the extension of actual timeframe, and
  • the way the communications between the Agency and the establishment should take place in the course of the inspection.

The aforementioned improvements are intended to assist medical device establishments in preparing for inspections. One of the most important novelties implemented by the updated regulation is the explicit prohibition of conducting unannounced inspections. 

As it is stated in the FDA guidance, industry representatives may provide feedback regarding the matter by submitting their comments and suggestions in the electronic form. These comments would be considered by the authority when creating the next revision of the document. 

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