sen-johnny-isaksonSenator Johnny Isakson [R-GA]

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. We hope his commentary brings a useful perspective to the new bill.

Anytime there is an administration change in the federal government, thoughts turn to potential changes in the regulatory environment. With a Republican chief executive and majorities in the 115th Congress, this year is no exception. On February 15th, Senator Johnny Isakson [R-GA] introduced S.404: a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.

Section 1 of the bill (Findings) describes the situation the bill is reacting to. Among the issues citied are:

  • Lack of transparency and consistency in FDA’s medical device establishment inspections globally
  • Foreign device establishment inspections more efficient (shorter?) than domestic inspections
  • Lack of comprehensive, transparent risk-based planning of inspections
  • Lack of transparency and consistency on frequency of inspections and justification of for-cause inspection
  • Need for transparency regarding timing and nature of device establishment inspections
  • Enhanced communications before, during, and after inspections - especially relating to feedback on adverse inspections
  • Need for enhanced training of device investigators
  • Problems with export certification process

The bill proposes changes to the act focusing on three distinct areas:

  • Risk-based inspection planning
  • Improvements to the inspection process
  • Issue of Certificates to Foreign Governments (export)

There seems to be a lot to like with this bill.

jake_headshot.jpgAs an ex-FDA investigator with significant domestic and international experience, I can attest first hand to the discrepancies in duration of domestic vs. foreign establishment inspections (the latter typically takes five days max, irrespective of risk significance). I have frequently been amazed upon hearing of about three and four month domestic establishment inspections. In 20 years I think I had one inspection that lasted more than two weeks, and that was caused by some back and forth with the center. Now that I have retired and work supporting the device industry, I have first-hand knowledge of - and a new appreciation for - the heavy burden of supporting agency inspections. This is even the case when they are somewhat consistent with the QSIT methodology’s four-day routine inspection design target.  Continuous and reasonable length inspections seem to me to be a very defensible expectation. Required scheduling consideration of a firm’s participation in international audit programs (read: MDSAP, maybe even 13485?) is another interesting development. Keep an eye out for details on our upcoming MDSAP webinar as part of the R&Q Intelligence Series, March 28th.


The bill would modify the Federal Food, Drug, and Cosmetic act in specific ways. Some examples:

  • Add requirements for establishment of risk-based schedule for inspections to be applied consistently across the country.
    • Specify risk-based planning approach
    • Required consideration of firm’s participation in international device audit programs when scheduling
    • Establish a standard time frame over consecutive days to which each inspector shall adhere, unless justified
    • Identify practices for investigators and device firms to facilitate uninterrupted inspections
  • Improvements to Inspection Process for Device Establishments (requires Secretary to adopt uniform process and standards for device inspections including):
    • Notifying firm of type and nature of inspection
    • Mandatory pre-announcement
    • For other than for-cause inspections, provide estimate of time frame for the inspection, enable communications related to working hours, and advance notice of required records
    • Timely provision of feedback to FDA 483 responses (within 45 days if requested by firm)
    • Sets timelines for issue of draft and final guidance documents to implement new inspection process requirements
    • Guidance is to include standardized time frame applicable to both domestic and international device inspections – deviation from standard timeframe will require justification

On Certificate to Foreign Governments / Export issues the bill seeks to amend Section 801 of the act to require the following:

  • When export certification is denied, Secretary must provide specific information to person seeking certification including basis for denial and specific finding upon which the denial is based
  • For denials not involving injunction, seizure actions, or Class I or II recalls, Secretary must provide a ‘substantive summary of specific deficiencies
  • Requests for certification not to be denied if mutually acceptable plan of correction is available after issue of an FDA 483
  • Establish a process for review of denied certifications, and provision of new information by applicant
  • Requires publishing guidance related to new CFG process.

We’ll be watching the progress of this bill, and others, that impact our clients. We encourage you to watch the progress of this bill, too. If interested in more detail, the complete text of S.404 can be found here.

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