This observation by Compliance Consultants concerns the review process at the Office of Device Evaluation
(ODE) the office in the Center of Devices & Radiological Health (CDRH) that reviews all medical devices for the
FDA.
Also refer to Refuse To Accept.
When the 510(k) is reviewed, after 90 days maximum, the ODE may / does ask for additional information (A.I.). Compliance Consultants has observed that for a typical Class II non-significant risk that usually can/has been tested to a harmonized standard- before about 2004, the ODE would ask about in 8-9 questions in the first round of "request for additional information". After up to a maximum of a 180 day period (the sponsor with the assistance of (Compliance Consultants) would respond. The ODE usually would ask 2-3 more questions that are a subset of the first 8-9 questions. Possibly a third round of questions might occur where ODE would ask another round of questions that may or may not apply the earlier round of questions. After Round 3, the ODE would correspond directly with Compliance Consultants to revise minor issues in the "Indications for Use" statement or the "510(k) Summary" statement. These two documents are destined to become public documents (30 days after the determination of substantial equivalence is announced).
In today's , environment of "strengthening at the CDRH". The ODE process of a "request for additional information" appears to be almost defined by a quota formula regardless of the quality of the application or the risk of the device. The ODE asks 38 questions spanning about 7 single spaced pages. We have seen Round 2 result in sometimes as many questions as Round 1. These questions can be a valid subset or introduce new issues. There are only 2 rounds of questions. The danger is that where new question are asked in Round 2, ODE leaves no mechanism to revisit an answer and simply returns a final determination of a "yes" or "no" (determination of substantial equivalence). That means that even 510(k) applications that embody compliance to harmonized standards are at grave risk of being determined not substantially equivalent and the exact final reason may not be apparent.
There is also a notable observation that deserves presentation. The ODE is far less transparent in 2012 than earlier years. Regardless of what you might be told verbally, the 5-7 CDRH people involved in phone conferences usually are not known to you. You do not know nor will you ever know the names or their authority. So when questions are posed, it is very difficult to respond and follow up. You may have a preset agenda, then the day of the call, a new slate of people show up than are completely different. Also, the CDRH did in earlier years have exhaustive telephone lists by department - fairly transparent. In today's environment- most all FDA CDRH individuals are obscured and the real accountability is obscured.
We present these observations to educate you about this process not to criticize the fine people at CDRH. They often in confidence express the same observations. Compliance Consultants has worked with other federal regulatory agencies such as FAA, FCC and OSHA. The FDA / CDRH / ODE is much better (in our opinion) and has more published standards than most other federal regulatory agencies.
Also refer to Refuse To Accept.
When the 510(k) is reviewed, after 90 days maximum, the ODE may / does ask for additional information (A.I.). Compliance Consultants has observed that for a typical Class II non-significant risk that usually can/has been tested to a harmonized standard- before about 2004, the ODE would ask about in 8-9 questions in the first round of "request for additional information". After up to a maximum of a 180 day period (the sponsor with the assistance of (Compliance Consultants) would respond. The ODE usually would ask 2-3 more questions that are a subset of the first 8-9 questions. Possibly a third round of questions might occur where ODE would ask another round of questions that may or may not apply the earlier round of questions. After Round 3, the ODE would correspond directly with Compliance Consultants to revise minor issues in the "Indications for Use" statement or the "510(k) Summary" statement. These two documents are destined to become public documents (30 days after the determination of substantial equivalence is announced).
In today's , environment of "strengthening at the CDRH". The ODE process of a "request for additional information" appears to be almost defined by a quota formula regardless of the quality of the application or the risk of the device. The ODE asks 38 questions spanning about 7 single spaced pages. We have seen Round 2 result in sometimes as many questions as Round 1. These questions can be a valid subset or introduce new issues. There are only 2 rounds of questions. The danger is that where new question are asked in Round 2, ODE leaves no mechanism to revisit an answer and simply returns a final determination of a "yes" or "no" (determination of substantial equivalence). That means that even 510(k) applications that embody compliance to harmonized standards are at grave risk of being determined not substantially equivalent and the exact final reason may not be apparent.
There is also a notable observation that deserves presentation. The ODE is far less transparent in 2012 than earlier years. Regardless of what you might be told verbally, the 5-7 CDRH people involved in phone conferences usually are not known to you. You do not know nor will you ever know the names or their authority. So when questions are posed, it is very difficult to respond and follow up. You may have a preset agenda, then the day of the call, a new slate of people show up than are completely different. Also, the CDRH did in earlier years have exhaustive telephone lists by department - fairly transparent. In today's environment- most all FDA CDRH individuals are obscured and the real accountability is obscured.
We present these observations to educate you about this process not to criticize the fine people at CDRH. They often in confidence express the same observations. Compliance Consultants has worked with other federal regulatory agencies such as FAA, FCC and OSHA. The FDA / CDRH / ODE is much better (in our opinion) and has more published standards than most other federal regulatory agencies.
